- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03777267
Cereset Research Exploratory Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary objective of this open label exploratory study is to evaluate the effect of CR to improve autonomic cardiovascular regulation in participants with symptoms of stress, anxiety, or insomnia.
The secondary objective is to evaluate the effect of CR on a variety of self-reported symptom inventories.
Tertiary objectives are to explore the impact of selected medications on outcomes associated with use of CR, the effect size in subgroups of participants who also report specific co-morbid symptoms or conditions of interest, and any unexpected challenges or barriers for working with the same. The latter includes those with TBI, PTSD, hypertension, hot flashes, chronic pain, or prior stroke.
Methods: This will be a single site, open label, pilot clinical trial, enrolling people aged 11 or older, who have self-reported symptoms of stress, anxiety, or insomnia, and meet a threshold score on self-reported inventories. Up to 150 participants will be enrolled. Participants will receive between 6 and 12 sessions of audible tones echoing current brainwave activity (CR). Participants will continue their other current care throughout the study. There will be pre- and post-intervention data collection of physiological outcomes (BP, HR, and measures of autonomic cardiovascular regulation assessed by heart rate variability and baroreflex sensitivity), which will alse serve as the primary outcome. Secondary outcomes to be collected include symptom inventories for insomnia (Insomnia Severity Index, ISI; Pittsburgh Sleep Quality Index, PSQI), depression (Center for Epidemiological Studies- Depression Scale, CES-D), anxiety (Generalized Anxiety Disorder-7, GAD-7), stress (Perceived Stress Scale, PSS), traumatic stress (PTSD Checklist for civilians, PCL-C, or military, PCL-M), , and overall quality of life (QOLS). Other secondary outcome inventories will be collected for physical activity (International Physical Activity Questionnaire, IPAQ-SF), and physical activity satisfaction questions, as well. Participants who also self-report having specific co-morbid symptoms or conditions of interest may complete additional condition-specific outcome measures. All measures will be collected at an enrollment visit (V1), and the intervention will begin 0-14 days thereafter. Mean contrasts will be used to compare the changes in measures of autonomic cardiovascular regulation from V1 to V3, the primary outcome, as well as for secondary outcomes. Linear mixed models, which can accommodate within-subject correlations due to repeated assessments over time, will be used to generate point estimates for effect size along with 95% confidence intervals.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Study Coordinator
- Phone Number: 336-716-9447
- Email: wfhirrem@wakehealth.edu
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27104
- Recruiting
- Department of Neurology, Wake Forest School of Medicine
-
Contact:
- Study Coordinator
- Phone Number: 336-716-9447
- Email: wfhirrem@wakehealth.edu
-
Principal Investigator:
- Charles Tegeler, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects must have the ability to comply with basic instructions and be able to sit still comfortably with the sensor leads attached
- Subjects experiencing symptoms of stress, anxiety, or insomnia, who meet threshold scores on one or more self-reported inventories for the same. This includes the Insomnia Severity Index (ISI, ≥ 8), the Perceived Stress Index (PSS, ≥ 14), or the Generalized Anxiety Disorder 7-item (GAD-7, ≥ 5) scale.
Exclusion Criteria:
- Unable, unwilling, or incompetent to provide informed consent/assent.
- Physically unable to come to the study visits, or to sit comfortably in a chair for up to 1.5 hours.
- Severe hearing impairment (because the subject will be using ear buds during CR).
- Anticipated and ongoing use of alcohol or recreational drugs.
- Weight is over the chair limit (285 pounds).
- Currently in another active intervention research study.
- Prior use of HIRREM, Brainwave Optimization, Cereset, or a wearable configuration of the same (B2, or B2v2).
- Prior use of electroconvulsive therapy (ECT).
- Prior use of transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), alpha stimulation, neurofeedback, biofeedback, or deep brain stimulation (DBS) within one month before enrollment.
- Known seizure disorder.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: Active CR
For this single arm, open label, exploratory trial this will be the intervention arm using active CR.
|
The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR).
This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM.
The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed.
Four sensors are applied to the scalp at a time.
However, only two sensors are actively echoing feedback.
The software automatically switches from one sensor pair to the other when needed.
This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Heart Rate Variability
Time Frame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval (SDNN, milliseconds).
For calculation of SDNN, the R-R intervals are visually inspected, and data considered as artifact is manually removed.
Heart rate are acquired from 10 minute recordings of noninvasive finger arterial pressure measurements and ECG with participants lying quietly, supine.
Systolic BP and beat to beat, RR intervals files generated via the data acquisition system (BIOPAC acquisition system and Acknowledge 4.2 software, Santa Barbara, CA), at 1000 Hz, are analyzed using Nevrokard BRS software (Nevrokard BRS, Medistar, Ljubljana, Slovenia).
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis.
|
Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
Change in Baroreflex Sensitivity
Time Frame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
BRS calculated by this method is based on quantification of sequences of at least three beats (n) in which SBP consecutively increases (UP sequence) or decreases (DOWN sequence), which are accompanied by changes in the same direction of the RRI of subsequent beats (n+1).
The software scans the RRI and SBP records, identifies sequences, and calculates linear correlation between RRI and SBP for each sequence.
The mean of all individual regression coefficients (slopes), a measure of sequence BRS, is calculated for Sequence UP, DOWN and ALL (ms/mmHg).
Blood pressure and heart rate are acquired from 10 minute recordings of noninvasive finger arterial pressure measurements and ECG with participants lying quietly, supine.
Systolic BP and beat to beat, RR intervals files generated via the data acquisition system (BIOPAC acquisition system and Acknowledge 4.2 software, Santa Barbara, CA), at 1000 Hz, are analyzed using Nevrokard BRS software (Nevrokard BRS, Medistar, Ljubljana, Slovenia).
|
Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
Change in Blood Pressure
Time Frame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
BP measurements will be obtained using an automate oscillometric blood pressure device.
Three samples will be obtained and the last two averaged to get the value that will be used as the reading for that visit.
|
Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
Change in Blood Pressure Variability
Time Frame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
Systolic BP and beat to beat, RR intervals (RRI) files generated via the data acquisition system (BIOPAC acquisition system and software, Santa Barbara, CA) at 1000 Hz are analyzed using Nevrokard SA-BRS software (by Nevrokard Kiauta, d.o.o., Izola, Slovenia) for measures BPV.Frequency Method.
Power spectral densities of SBP and RRI oscillations are computed by 512 points Fast Fourier Transform (FFT) and integrated over specified frequency ranges (LF: 0.04-0.15
Hz; HF: 0.15-0.4
Hz).
|
Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Insomnia Severity Index (ISI)
Time Frame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
The severity of insomnia symptoms is measured using the ISI with each data collection visit.
The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28.
Higher scores indicate the strength of the insomnia severity.
|
Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
Change in Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
The PSQI is a 19 item inventory that assesses sleep quality over a 1-month time interval.
Items are weighted on a 0-3 interval scale.
A global PSQI score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
|
Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
Change in Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression.
Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off.
Higher scores indicate the presence of more symptomatology.
|
Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
Change in Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
The GAD-7 is a seven item screening tool for anxiety that is widely used in primary care.
Scores range from 0-21.
A lower score denotes a lower level of anxiety.
|
Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
Change in Perceived Stress Scale (PSS)
Time Frame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
The PSS is a ten-item psychological instrument for measuring the perception of stress.
It is a measure of the degree to which situations in one's life are appraised as stressful.
Scores range from 0-40.
A lower score denotes a lower level of perceived stress.
|
Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
Change in Quality of Life Scale (QOLS)
Time Frame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
The QOLS is a 16-item scale that was modified from a 15-item scale used in chronic disease patients.
Topics include different components of daily life such as relationships, community engagement, personal fulfillment, and recreation.
Each item is scaled from 1 to 7 and a sum score is calculated to represent higher levels of satisfaction in life (range is 16-112).
|
Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
Change in PTSD Checklist for Civilians (PCL-C)
Time Frame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
The PCL-C measures the American Psychiatric Association's Diagnostic and statistical manual of mental disorders (DSM-IV) Criteria B, C, & D of PTSD symptoms based on traumatic life experience related to civilians.
Seventeen items are rated on a Likert scale with a composite score range of 17 to 85.
A score of 44 or higher correlates with probability of civilian-related PTSD.
|
Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
Change in International Physical Activity Questionnaire (IPAQ-SF)
Time Frame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
This is a four item questionnaire asking about physical activity in the last 7 days.
Scores are calculated and categorized as low, moderate, or high.
A higher score denotes more physical activity.
|
Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
Change in HIRREM Physical Activity Satisfaction Questions
Time Frame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
This is a four item questionnaire asking about the participants level of satisfaction with their physical activity.
Responses range from 0-6 for each question, yielding scores ranging from 0-24.
Higher scores denote a higher level of satisfaction.
|
Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Charles Tegeler, MD, Wake Forest University Health Sciences
Publications and helpful links
General Publications
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
- Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
- Beauchaine TP, Thayer JF. Heart rate variability as a transdiagnostic biomarker of psychopathology. Int J Psychophysiol. 2015 Nov;98(2 Pt 2):338-350. doi: 10.1016/j.ijpsycho.2015.08.004. Epub 2015 Aug 11.
- Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998 Sep 14;158(16):1789-95. doi: 10.1001/archinte.158.16.1789.
- Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.
- Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30.
- Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
- Riemann D, Spiegelhalder K, Feige B, Voderholzer U, Berger M, Perlis M, Nissen C. The hyperarousal model of insomnia: a review of the concept and its evidence. Sleep Med Rev. 2010 Feb;14(1):19-31. doi: 10.1016/j.smrv.2009.04.002. Epub 2009 May 28.
- Blanchard EB, Jones-Alexander J, Buckley TC, Forneris CA. Psychometric properties of the PTSD Checklist (PCL). Behav Res Ther. 1996 Aug;34(8):669-73. doi: 10.1016/0005-7967(96)00033-2.
- Smarr KL, Keefer AL. Measures of depression and depressive symptoms: Beck Depression Inventory-II (BDI-II), Center for Epidemiologic Studies Depression Scale (CES-D), Geriatric Depression Scale (GDS), Hospital Anxiety and Depression Scale (HADS), and Patient Health Questionnaire-9 (PHQ-9). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S454-66. doi: 10.1002/acr.20556. No abstract available.
- Fortunato JE, Tegeler CL, Gerdes L, Lee SW, Pajewski NM, Franco ME, Cook JF, Shaltout HA, Tegeler CH. Use of an allostatic neurotechnology by adolescents with postural orthostatic tachycardia syndrome (POTS) is associated with improvements in heart rate variability and changes in temporal lobe electrical activity. Exp Brain Res. 2016 Mar;234(3):791-8. doi: 10.1007/s00221-015-4499-y. Epub 2015 Dec 8.
- Bradley KA, Bush KR, Epler AJ, Dobie DJ, Davis TM, Sporleder JL, Maynard C, Burman ML, Kivlahan DR. Two brief alcohol-screening tests From the Alcohol Use Disorders Identification Test (AUDIT): validation in a female Veterans Affairs patient population. Arch Intern Med. 2003 Apr 14;163(7):821-9. doi: 10.1001/archinte.163.7.821.
- Tsuji H, Larson MG, Venditti FJ Jr, Manders ES, Evans JC, Feldman CL, Levy D. Impact of reduced heart rate variability on risk for cardiac events. The Framingham Heart Study. Circulation. 1996 Dec 1;94(11):2850-5. doi: 10.1161/01.cir.94.11.2850.
- Burckhardt CS, Anderson KL. The Quality of Life Scale (QOLS): reliability, validity, and utilization. Health Qual Life Outcomes. 2003 Oct 23;1:60. doi: 10.1186/1477-7525-1-60.
- Kemp AH, Griffiths K, Felmingham KL, Shankman SA, Drinkenburg W, Arns M, Clark CR, Bryant RA. Disorder specificity despite comorbidity: resting EEG alpha asymmetry in major depressive disorder and post-traumatic stress disorder. Biol Psychol. 2010 Oct;85(2):350-4. doi: 10.1016/j.biopsycho.2010.08.001. Epub 2010 Aug 11.
- Metzger LJ, Paige SR, Carson MA, Lasko NB, Paulus LA, Pitman RK, Orr SP. PTSD arousal and depression symptoms associated with increased right-sided parietal EEG asymmetry. J Abnorm Psychol. 2004 May;113(2):324-9. doi: 10.1037/0021-843X.113.2.324.
- Hale TS, Smalley SL, Walshaw PD, Hanada G, Macion J, McCracken JT, McGough JJ, Loo SK. Atypical EEG beta asymmetry in adults with ADHD. Neuropsychologia. 2010 Oct;48(12):3532-9. doi: 10.1016/j.neuropsychologia.2010.08.002. Epub 2010 Aug 10.
- Hale TS, Smalley SL, Dang J, Hanada G, Macion J, McCracken JT, McGough JJ, Loo SK. ADHD familial loading and abnormal EEG alpha asymmetry in children with ADHD. J Psychiatr Res. 2010 Jul;44(9):605-15. doi: 10.1016/j.jpsychires.2009.11.012. Epub 2009 Dec 16.
- Hale TS, Smalley SL, Hanada G, Macion J, McCracken JT, McGough JJ, Loo SK. Atypical alpha asymmetry in adults with ADHD. Neuropsychologia. 2009 Aug;47(10):2082-8. doi: 10.1016/j.neuropsychologia.2009.03.021. Epub 2009 Apr 5.
- Lazarev VV, Pontes A, Mitrofanov AA, deAzevedo LC. Interhemispheric asymmetry in EEG photic driving coherence in childhood autism. Clin Neurophysiol. 2010 Feb;121(2):145-52. doi: 10.1016/j.clinph.2009.10.010. Epub 2009 Dec 1.
- Stroganova TA, Nygren G, Tsetlin MM, Posikera IN, Gillberg C, Elam M, Orekhova EV. Abnormal EEG lateralization in boys with autism. Clin Neurophysiol. 2007 Aug;118(8):1842-54. doi: 10.1016/j.clinph.2007.05.005. Epub 2007 Jun 19.
- Thibodeau R, Jorgensen RS, Kim S. Depression, anxiety, and resting frontal EEG asymmetry: a meta-analytic review. J Abnorm Psychol. 2006 Nov;115(4):715-29. doi: 10.1037/0021-843X.115.4.715.
- Avram J, Baltes FR, Miclea M, Miu AC. Frontal EEG activation asymmetry reflects cognitive biases in anxiety: evidence from an emotional face Stroop task. Appl Psychophysiol Biofeedback. 2010 Dec;35(4):285-92. doi: 10.1007/s10484-010-9138-6.
- Spironelli C, Penolazzi B, Angrilli A. Dysfunctional hemispheric asymmetry of theta and beta EEG activity during linguistic tasks in developmental dyslexia. Biol Psychol. 2008 Feb;77(2):123-31. doi: 10.1016/j.biopsycho.2007.09.009. Epub 2007 Oct 2.
- Moscovitch DA, Santesso DL, Miskovic V, McCabe RE, Antony MM, Schmidt LA. Frontal EEG asymmetry and symptom response to cognitive behavioral therapy in patients with social anxiety disorder. Biol Psychol. 2011 Jul;87(3):379-85. doi: 10.1016/j.biopsycho.2011.04.009. Epub 2011 May 13.
- Rabe S, Beauducel A, Zollner T, Maercker A, Karl A. Regional brain electrical activity in posttraumatic stress disorder after motor vehicle accident. J Abnorm Psychol. 2006 Nov;115(4):687-98. doi: 10.1037/0021-843X.115.4.687.
- Marzano C, Ferrara M, Sforza E, De Gennaro L. Quantitative electroencephalogram (EEG) in insomnia: a new window on pathophysiological mechanisms. Curr Pharm Des. 2008;14(32):3446-55. doi: 10.2174/138161208786549326.
- Cohen H, Benjamin J, Geva AB, Matar MA, Kaplan Z, Kotler M. Autonomic dysregulation in panic disorder and in post-traumatic stress disorder: application of power spectrum analysis of heart rate variability at rest and in response to recollection of trauma or panic attacks. Psychiatry Res. 2000 Sep 25;96(1):1-13. doi: 10.1016/s0165-1781(00)00195-5.
- Katz-Leurer M, Rotem H, Keren O, Meyer S. Heart rate and heart rate variability at rest and during exercise in boys who suffered a severe traumatic brain injury and typically-developed controls. Brain Inj. 2010 Feb;24(2):110-4. doi: 10.3109/02699050903508234.
- Beckham JC, Taft CT, Vrana SR, Feldman ME, Barefoot JC, Moore SD, Mozley SL, Butterfield MI, Calhoun PS. Ambulatory monitoring and physical health report in Vietnam veterans with and without chronic posttraumatic stress disorder. J Trauma Stress. 2003 Aug;16(4):329-35. doi: 10.1023/A:1024457700599.
- Spiegelhalder K, Fuchs L, Ladwig J, Kyle SD, Nissen C, Voderholzer U, Feige B, Riemann D. Heart rate and heart rate variability in subjectively reported insomnia. J Sleep Res. 2011 Mar;20(1 Pt 2):137-45. doi: 10.1111/j.1365-2869.2010.00863.x.
- Tobaldini E, Nobili L, Strada S, Casali KR, Braghiroli A, Montano N. Heart rate variability in normal and pathological sleep. Front Physiol. 2013 Oct 16;4:294. doi: 10.3389/fphys.2013.00294.
- Dekker JM, Schouten EG, Klootwijk P, Pool J, Swenne CA, Kromhout D. Heart rate variability from short electrocardiographic recordings predicts mortality from all causes in middle-aged and elderly men. The Zutphen Study. Am J Epidemiol. 1997 May 15;145(10):899-908. doi: 10.1093/oxfordjournals.aje.a009049.
- Lee EA, Bissett JK, Carter MA, Cowan PA, Pyne JM, Speck PM, Theus SA, Tolley EA. Preliminary findings of the relationship of lower heart rate variability with military sexual trauma and presumed posttraumatic stress disorder. J Trauma Stress. 2013 Apr;26(2):249-56. doi: 10.1002/jts.21797.
- Shah AJ, Lampert R, Goldberg J, Veledar E, Bremner JD, Vaccarino V. Posttraumatic stress disorder and impaired autonomic modulation in male twins. Biol Psychiatry. 2013 Jun 1;73(11):1103-10. doi: 10.1016/j.biopsych.2013.01.019. Epub 2013 Feb 21.
- Minassian A, Geyer MA, Baker DG, Nievergelt CM, O'Connor DT, Risbrough VB; Marine Resiliency Study Team. Heart rate variability characteristics in a large group of active-duty marines and relationship to posttraumatic stress. Psychosom Med. 2014 May;76(4):292-301. doi: 10.1097/PSY.0000000000000056.
- Park J, Marvar PJ, Liao P, Kankam ML, Norrholm SD, Downey RM, McCullough SA, Le NA, Rothbaum BO. Baroreflex dysfunction and augmented sympathetic nerve responses during mental stress in veterans with post-traumatic stress disorder. J Physiol. 2017 Jul 15;595(14):4893-4908. doi: 10.1113/JP274269. Epub 2017 Jun 14.
- Park JE, Lee JY, Kang SH, Choi JH, Kim TY, So HS, Yoon IY. Heart rate variability of chronic posttraumatic stress disorder in the Korean veterans. Psychiatry Res. 2017 Sep;255:72-77. doi: 10.1016/j.psychres.2017.05.011. Epub 2017 May 9.
- Minassian A, Maihofer AX, Baker DG, Nievergelt CM, Geyer MA, Risbrough VB; Marine Resiliency Study Team. Association of Predeployment Heart Rate Variability With Risk of Postdeployment Posttraumatic Stress Disorder in Active-Duty Marines. JAMA Psychiatry. 2015 Oct;72(10):979-86. doi: 10.1001/jamapsychiatry.2015.0922.
- Pyne JM, Constans JI, Wiederhold MD, Gibson DP, Kimbrell T, Kramer TL, Pitcock JA, Han X, Williams DK, Chartrand D, Gevirtz RN, Spira J, Wiederhold BK, McCraty R, McCune TR. Heart rate variability: Pre-deployment predictor of post-deployment PTSD symptoms. Biol Psychol. 2016 Dec;121(Pt A):91-98. doi: 10.1016/j.biopsycho.2016.10.008. Epub 2016 Oct 20.
- Kleiger RE, Miller JP, Bigger JT Jr, Moss AJ. Decreased heart rate variability and its association with increased mortality after acute myocardial infarction. Am J Cardiol. 1987 Feb 1;59(4):256-62. doi: 10.1016/0002-9149(87)90795-8.
- Carnethon MR, Golden SH, Folsom AR, Haskell W, Liao D. Prospective investigation of autonomic nervous system function and the development of type 2 diabetes: the Atherosclerosis Risk In Communities study, 1987-1998. Circulation. 2003 May 6;107(17):2190-5. doi: 10.1161/01.CIR.0000066324.74807.95. Epub 2003 Apr 14.
- Chandra P, Sands RL, Gillespie BW, Levin NW, Kotanko P, Kiser M, Finkelstein F, Hinderliter A, Pop-Busui R, Rajagopalan S, Saran R. Predictors of heart rate variability and its prognostic significance in chronic kidney disease. Nephrol Dial Transplant. 2012 Feb;27(2):700-9. doi: 10.1093/ndt/gfr340. Epub 2011 Sep 12.
- Marsac J. [Heart rate variability: a cardiometabolic risk marker with public health implications]. Bull Acad Natl Med. 2013 Jan;197(1):175-86. French.
- Thayer JF, Hansen AL, Saus-Rose E, Johnsen BH. Heart rate variability, prefrontal neural function, and cognitive performance: the neurovisceral integration perspective on self-regulation, adaptation, and health. Ann Behav Med. 2009 Apr;37(2):141-53. doi: 10.1007/s12160-009-9101-z. Epub 2009 May 8.
- Nolan RP, Jong P, Barry-Bianchi SM, Tanaka TH, Floras JS. Effects of drug, biobehavioral and exercise therapies on heart rate variability in coronary artery disease: a systematic review. Eur J Cardiovasc Prev Rehabil. 2008 Aug;15(4):386-96. doi: 10.1097/HJR.0b013e3283030a97.
- Lee SW, Gerdes L, Tegeler CL, Shaltout HA, Tegeler CH. A bihemispheric autonomic model for traumatic stress effects on health and behavior. Front Psychol. 2014 Aug 1;5:843. doi: 10.3389/fpsyg.2014.00843. eCollection 2014.
- Bellesi M, Riedner BA, Garcia-Molina GN, Cirelli C, Tononi G. Enhancement of sleep slow waves: underlying mechanisms and practical consequences. Front Syst Neurosci. 2014 Oct 28;8:208. doi: 10.3389/fnsys.2014.00208. eCollection 2014.
- Gerdes L, Gerdes P, Lee SW, H Tegeler C. HIRREM: a noninvasive, allostatic methodology for relaxation and auto-calibration of neural oscillations. Brain Behav. 2013 Mar;3(2):193-205. doi: 10.1002/brb3.116. Epub 2013 Jan 14.
- Sterling P. Allostasis: a model of predictive regulation. Physiol Behav. 2012 Apr 12;106(1):5-15. doi: 10.1016/j.physbeh.2011.06.004. Epub 2011 Jun 12.
- Tegeler CH, Kumar SR, Conklin D, Lee SW, Gerdes L, Turner DP, Tegeler CL, C Fidali B, Houle TT. Open label, randomized, crossover pilot trial of high-resolution, relational, resonance-based, electroencephalic mirroring to relieve insomnia. Brain Behav. 2012 Nov;2(6):814-24. doi: 10.1002/brb3.101. Epub 2012 Oct 28.
- Tegeler CH, Tegeler CL, Cook JF, Lee SW, Pajewski NM. Reduction in menopause-related symptoms associated with use of a noninvasive neurotechnology for autocalibration of neural oscillations. Menopause. 2015 Jun;22(6):650-5. doi: 10.1097/GME.0000000000000422.
- Tegeler CH, Tegeler CL, Cook JF, Lee SW, Gerdes L, Shaltout HA, Miles CM, Simpson SL. A Preliminary Study of the Effectiveness of an Allostatic, Closed-Loop, Acoustic Stimulation Neurotechnology in the Treatment of Athletes with Persisting Post-concussion Symptoms. Sports Med Open. 2016 Dec;2(1):39. doi: 10.1186/s40798-016-0063-y. Epub 2016 Sep 14.
- Tegeler CL, Gerdes L, Shaltout HA, Cook JF, Simpson SL, Lee SW, Tegeler CH. Successful use of closed-loop allostatic neurotechnology for post-traumatic stress symptoms in military personnel: self-reported and autonomic improvements. Mil Med Res. 2017 Dec 22;4(1):38. doi: 10.1186/s40779-017-0147-0.
- Tegeler CH, Shaltout HA, Tegeler CL, Gerdes L, Lee SW. Rightward dominance in temporal high-frequency electrical asymmetry corresponds to higher resting heart rate and lower baroreflex sensitivity in a heterogeneous population. Brain Behav. 2015 Jun;5(6):e00343. doi: 10.1002/brb3.343. Epub 2015 May 1.
- Lee SW, Laurienti PJ, Burdette JH, Tegeler CL, Morgan AR, Simpson SL, Gerdes L, Tegeler CH. Functional Brain Network Changes Following Use of an Allostatic, Closed-Loop, Acoustic Stimulation Neurotechnology for Military-Related Traumatic Stress. J Neuroimaging. 2019 Jan;29(1):70-78. doi: 10.1111/jon.12571. Epub 2018 Oct 10.
- Tegeler CL, Howard LJ, Schmidt KD, Cook JF, Kumar S, Simpson SL, Lee SW, Gerdes L, Tegeler CH. 0389 USE OF A CLOSED-LOOP ACOUSTIC STIMULATION NEUROTECHNOLOGY IMPROVES SYMPTOMS OF MODERATE TO SEVERE INSOMNIA: RESULTS OF A PLACEBO-CONTROLLED TRIAL. Sleep. 2017;40:A145-A.
- Shaltout HA, Tegeler CL, Lee SW, Tegeler CH. 0363 IN SUBJECTS WITH INSOMNIA, USE OF A CLOSED-LOOP ACOUSTIC STIMULATION NEUROTECHNOLOGY IMPROVES HEART RATE VARIABILITY AND BAROREFLEX SENSITIVITY: RESULTS OF A PLACEBO-CONTROLLED CLINICAL TRIAL. Sleep. 2017;40:A135-A
- Kaplan NM RB. Technique of blood pressure measurement in the diagnosis of hypertension. UpToDate. Barkris GL, Sheridan AM, eds. Waltham, MA; 2010.
- Radloff LS. The CES-D Scale: A Self-Report Depression Scale for Research in the General Population. Applied Psychological Measurement. 1977;1:385-401.
- FW W, BT L, DS H, JA H, TM K. The PTSD Checklist (PCL): Reliability, validity, and diagnostic utility. 9th Annual Meeting of the International Society for Traumatic Stress Studies. San Antonio, TX.
- Offenbacher M, Sauer S, Kohls N, Waltz M, Schoeps P. Quality of life in patients with fibromyalgia: validation and psychometric properties of the German Quality of Life Scale (QOLS-G). Rheumatol Int. 2012 Oct;32(10):3243-52. doi: 10.1007/s00296-011-2184-4. Epub 2011 Oct 30.
- Bradley KA, DeBenedetti AF, Volk RJ, Williams EC, Frank D, Kivlahan DR. AUDIT-C as a brief screen for alcohol misuse in primary care. Alcohol Clin Exp Res. 2007 Jul;31(7):1208-17. doi: 10.1111/j.1530-0277.2007.00403.x. Epub 2007 Apr 19.
- Burckhardt CS, Woods SL, Schultz AA, Ziebarth DM. Quality of life of adults with chronic illness: a psychometric study. Res Nurs Health. 1989 Dec;12(6):347-54. doi: 10.1002/nur.4770120604.
- Eckner JT, Kutcher JS, Richardson JK. Pilot evaluation of a novel clinical test of reaction time in national collegiate athletic association division I football players. J Athl Train. 2010 Jul-Aug;45(4):327-32. doi: 10.4085/1062-6050-45.4.327.
- Wolynczyk-Gmaj D, Szelenberger W. Waking EEG in primary insomnia. Acta Neurobiol Exp (Wars). 2011;71(3):387-92. doi: 10.55782/ane-2011-1860.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00055280
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neurological Diseases or Conditions
-
University of LeedsThe Royal College of Surgeons of EnglandCompletedSurgery | Surgery--Complications | Outcome, Fatal | Neurological Disorder | Morality | Neurological Morbidity | Neurological Complication | Comorbidities and Coexisting Conditions | Neurological Diseases or Conditions | Neurological Procedural Complication
-
Hospices Civils de LyonActive, not recruitingNeurological Diseases or Conditions | Neurological Diseases Associated to Anti GFAP AntibodiesFrance
-
Madonna Rehabilitation HospitalActive, not recruitingNeurological Injury | Neurological Diseases or ConditionsUnited States
-
Hospital General Universitario de CastellónTerminatedNeurological Diseases or ConditionsSpain
-
Sintetica SASintesi Research SrlCompletedNeurological Complication, in Particular TNS or CESBelgium
-
University Hospital, CaenCompletedPhysical Disability | Neurological Diseases or ConditionsFrance
-
IRCCS Eugenio MedeaCompletedNeurological Diseases or ConditionsItaly
-
University of FribourgInsel Gruppe AG, University Hospital BernRecruitingFunctional Neurological Symptom Disorder | Neurological Diseases or ConditionsSwitzerland
-
BioSerenityUnknownHealthy Volunteers Without Any Cardiac or Any Neurological DisordersFrance
-
King's College Hospital NHS TrustKing's College LondonRecruitingNeurological DisorderUnited Kingdom
Clinical Trials on Active CR
-
University of BathRoyal United Hospitals Bath NHS Foundation TrustRecruitingCardiovascular DiseasesUnited Kingdom
-
GlaxoSmithKlineActive, not recruiting
-
PfizerCompletedRheumatoid ArthritisUnited States
-
University of CalgaryUniversity of British Columbia; Alberta Health servicesRecruitingObesity | Atrial FibrillationCanada
-
Columbia UniversityNational Institutes of Health (NIH); National Center for Advancing Translational...SuspendedMyocardial Infarction | Acute Coronary SyndromeUnited States
-
Jing MaUnknownHeart Failure | Acute Myocardial InfarctionChina
-
University of North Carolina, Chapel HillCompleted
-
Zimmer BiometCompletedOsteoarthritis | Total Knee ArthroplastyUnited States
-
Beijing Anzhen HospitalBeijing Chao Yang Hospital; Beijing Luhe HospitalNot yet recruitingST-elevation Myocardial Infarction | Multivessel Coronary DiseaseChina
-
Centre for Addiction and Mental HealthCAMH FoundationActive, not recruitingMild Cognitive Impairment | Major Depressive Disorder | tDCS | Transcranial Direct Current Stimulation | Alzheimer's DementiaCanada