- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02615535
Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury
Neurofeedback-enhanced Mindfulness Meditation for the Treatment of Affective and Attentional Disturbances in Patients With Traumatic Brain Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Twenty subjects in total will participate in this study. Subjects will be randomized to focused-attention meditation training with or without the neurofeedback device, MUSE. Subjects will be asked to practice ~10 min of daily meditation for 6-8 weeks. Neuropsychological testing will be performed at the beginning of the study and after six weeks of training. At this time point, those randomized to the non-MUSE group will be given a device and asked to train for an additional two weeks. At the conclusion of the study, all subjects will also undergo a brief telephone or in-person exit interview regarding their experiences using the MUSE device.
Primary endpoint: change in Neurobehavioral Symptom Inventory
Secondary endpoints: change in the following: Wechsler Adult Intelligence Scale-IV Digit Span and Symbol-Digit Coding, Trail-Making Test, Beck Anxiety Inventory, Beck Depression Inventory, Cognitive and Affective Mindfulness Scale-Revised, percentage of EEG activity associated with alpha, beta, or theta activity.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Charlestown, Massachusetts, United States, 02129
- Spaulding Rehabilitation Hospital Boston
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- history of mild-moderate traumatic brain injury
- impaired attention or concentration
- >1 year since traumatic brain injury
- ability to participate in neurofeedback and mindfulness meditation
- daily access to a smart phone
- on stable dosage of neuropsychological medications with no significant changes planned for the duration of the study
- no prior history of a meditation practice
Exclusion Criteria:
- severe mental illness or psychological symptoms (severe depression, suicidality, disabling anxiety, PTSD, psychosis, dissociation)
- significant pre-morbid learning disability
- current or recent (in past year) history of significant drug or alcohol abuse
- medical illness severe enough to result in an attentional disorder
- neurodegenerative disease
- non-fluency in English.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EEG neurofeedback-assisted meditation
EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.
|
meditation with auditory feedback regarding EEG status
Other Names:
|
Active Comparator: Non-EEG feedback-assisted meditation
Non-EEG neurofeedback assisted meditation.
Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.
|
meditation without auditory feedback regarding EEG status
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Neurobehavioral Symptom Inventory
Time Frame: baseline and six weeks
|
Measures common symptoms after head injury.
This scales ranges from 0-4 on 22 items, for a minimum score of 0 and a maximum score of 88.
Higher scores mean a greater severity of symptoms.
|
baseline and six weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Wechsler Adult Intelligence Scale-IV Digit Span
Time Frame: baseline and six weeks
|
Tests participants digit span, repeating forward sequences of digits from 2 to 8. Scale ranges from 0 to 16.
Higher scores mean a better outcome.
|
baseline and six weeks
|
Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding
Time Frame: baseline and six weeks
|
A subject is provided with a key matching nine numbers to nine unique symbols.
Numbers are then provided in random order and subjects have 120 seconds to match as many numbers with symbols as possible.
All correct responses are scored.
Scores range from 0 to 135.
Scores are later scaled from 1 to 19.
Higher scores mean a better outcome.
|
baseline and six weeks
|
Change in Trail Making Test
Time Frame: baseline and six weeks
|
Subjects are asked to sequence numbers and letters represented on a page as quickly as then can.
Results are measured in seconds, ranging from 0 (hypothetically) to an infinite number (hypothetically).
Results are scaled from 1 to 19.
Lower scores mean a better outcome.
|
baseline and six weeks
|
Change in Beck Anxiety Inventory
Time Frame: baseline and six weeks
|
Subjects rate on a 0-3 likert scales responses to questions about anxiety.
Scores range from 0-63.
Lower scores mean a better outcome.
|
baseline and six weeks
|
Change in Beck Depression Inventory-II
Time Frame: baseline and six weeks
|
Subjects respond to questions on a Likert scale from 0-3 regarding depressive symptoms.
There are 21 items.
Scores range from 0-63.
Lower scores mean a better outcome.
|
baseline and six weeks
|
Change in Cognitive and Affective Mindfulness Scale-Revised
Time Frame: baseline and six weeks
|
Subjects answer questions regarding mindfulness on a Likert Scale from 1-4.
There are twelve questions total.
Scores range from 4-48.
Higher scores mean a better outcome.
|
baseline and six weeks
|
Change in Percentage of EEG Activity Associated With Alpha, Beta, and Theta Rhythms as Measured by Surface Electrodes on the MUSE Device
Time Frame: baseline and at six weeks
|
Change in "percent Calm" as determined by Muse device.
Equations behind this algorithm to determine "Calm" are proprietary and were not shared by the device manufacturer.
Ranges from 0% to 100%.
Higher scores mean a better outcome.
|
baseline and at six weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mel B Glenn, MD, Spaulding Rehabilitation Hospital
Publications and helpful links
General Publications
- Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015.
- Chiesa A, Calati R, Serretti A. Does mindfulness training improve cognitive abilities? A systematic review of neuropsychological findings. Clin Psychol Rev. 2011 Apr;31(3):449-64. doi: 10.1016/j.cpr.2010.11.003. Epub 2010 Dec 1.
- Brandmeyer T, Delorme A. Meditation and neurofeedback. Front Psychol. 2013 Oct 7;4:688. doi: 10.3389/fpsyg.2013.00688. eCollection 2013. No abstract available.
- Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.
- Polich G, Gray S, Tran D, Morales-Quezada L, Glenn M. Comparing focused attention meditation to meditation with mobile neurofeedback for persistent symptoms after mild-moderate traumatic brain injury: a pilot study. Brain Inj. 2020 Aug 23;34(10):1408-1415. doi: 10.1080/02699052.2020.1802781. Epub 2020 Aug 12.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
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
- 2015P002184
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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 Traumatic Brain Injury
-
Fondazione per la Ricerca Ospedale MaggioreCompletedBrain Injuries, Traumatic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateItaly
-
Toronto Rehabilitation InstituteCentre for Aging and Brain Health Innovation; Ontario Neurotrauma FoundationUnknownBrain Injuries, Traumatic | Brain Injury, Chronic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateCanada
-
Hospital Sirio-LibanesUniversity of Sao Paulo; Ministry of Health, Brazil; Hospital Sao Rafael; PROAD... and other collaboratorsRecruitingBrain Injury Traumatic Severe | Brain Injury Traumatic Moderate | Post Traumatic EpilepsyBrazil
-
University of TurkuTurku University Hospital; The Finnish Funding Agency for Technology and Innovation... and other collaboratorsCompletedBrain Injuries | TBI (Traumatic Brain Injury) | Brain Injuries, Traumatic | Traumatic Brain Injury | Injury, Brain, TraumaticFinland
-
Children's Hospital Medical Center, CincinnatiUniversity of CincinnatiCompletedBrain Injury Traumatic MildUnited States
-
BrainScope Company, Inc.RecruitingTBI (Traumatic Brain Injury) | Concussion, Brain | MTBI - Mild Traumatic Brain Injury | Closed Head InjuryUnited States
-
Institut National de la Santé Et de la Recherche...Institut National de Recherche en Informatique et en AutomatiqueNot yet recruitingTBI (Traumatic Brain Injury)France
-
University of Sao Paulo General HospitalUnknownTraumatic Brain Injury | Severe Brain Injury | Closed Traumatic Brain InjuryBrazil
-
First Affiliated Hospital Xi'an Jiaotong UniversityXijing Hospital; Second Affiliated Hospital of Wenzhou Medical University; Central... and other collaboratorsRecruitingMTBI - Mild Traumatic Brain Injury | Moderate Traumatic Brain InjuryChina
-
First Affiliated Hospital Xi'an Jiaotong UniversityHealth Science Center of Xi'an Jiaotong University; The Second Affiliated Hospital...RecruitingMTBI - Mild Traumatic Brain InjuryChina
Clinical Trials on EEG neurofeedback-assisted meditation
-
Steinn SteingrimssonRecruiting
-
Children's Hospital Medical Center, CincinnatiThe Society for Pediatric AnesthesiaActive, not recruiting
-
Radboud University Medical CenterCompleted
-
University of North Carolina, WilmingtonCompleted
-
Tel-Aviv Sourasky Medical CenterUnknownDepression | Premenstrual Dysphoric Disorder (PMDD)Israel
-
Tel-Aviv Sourasky Medical CenterUnknownDepression | StressIsrael
-
Centre Hospitalier Universitaire de BesanconPlateforme NeuraxessRecruitingEmotional Regulation | Risk-TakingFrance
-
University of ConnecticutUnknown
-
Rennes University HospitalUnknown
-
Wyss Center for Bio and NeuroengineeringEcole Polytechnique Fédérale de LausanneCompleted