- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02509689
Neurofeedback Technology (GZNT) for Persistent Post-Concussive Symptoms in Soldiers (GZNT)
Feasibility Study of a Novel Neurofeedback Technology (GZNT) for Persistent Post-Concussive Symptoms in Soldiers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Research Design: This will be a single group design, treatment effect and feasibility study to demonstrate GZNT technology, examining electrocortical changes, and comparing emotional/vocational functioning, and post concussive symptoms before and after intensive GZNT treatment, and at three months follow-up. Up to 50 subjects with a history of traumatic brain injury and persistent cognitive and emotional symptoms will be enrolled following screening and baseline evaluation. Resting and event-related EEG (electroencephalograph) recordings, a physiological stress evaluation, neuropsychological tests, self-report symptom scales, and psychosocial/vocational functioning measures will be performed at each evaluation. All subjects will receive the study treatment intervention. Subjects will be scheduled to receive twenty treatment sessions of GZNT over a six week period, but will be counted as having completed treatment if they attend fifteen or more sessions. At least twenty-five subjects will need to complete treatment to meet statistical requirements for the study hypotheses.
Primary outcome measures will include electrocortical indices under resting and mental task states and will evaluate the degree of neuro-physiological and cortical functional connectivity change following treatment as a proxy measure for neuroplastic response to the GZNT training. Secondary outcomes will include physiological stress response (as an objective measure of emotional regulation), neuropsychological test performance (as an objective measure of cognition), and self-reported symptom and emotional well-being measures. Feasibility outcomes will include number of visits completed within the six weeks, number and reason for drop-outs, adverse event profiles, and patient satisfaction questionnaires.
Methodology/Technical: For this pilot study, the investigators will require twenty-five patients to complete the study. The investigators will therefore recruit as many as are necessary to achieve this goal, to a maximum of 50 patients. However, since this is a feasibility study, the dropout rate and reasons for drop outs will be monitored and reported. Completion of a minimum of fifteen study treatment visits will satisfy requirements for "study completion." (This is based on clinical experience data with this technology.) Therefore, only those who complete fourteen or fewer sessions within the six week study treatment time window will be counted as drop outs. The planned total number of study sessions for the study will be twenty. Data analysis will be carried out on pre and post metrics for the group who completed the trial, and secondary analyses will be carried out on all subjects using an intention-to-treat paradigm, to evaluate feasibility, and acceptance of this intervention.
Subjects will be recruited from the Warrior Recovery Center, the Soldier Readiness Center, and Evans Army Hospital Primary Care Clinics. Subjects will be pre-screened by signing an initial consent and completing a preliminary set of self-report forms, followed by a review of medical records in order to determine eligibility. Following eligibility determination, full consent discussion will be held, and baseline evaluations will be completed and study visits scheduled.
For this pilot efficacy/feasibility study, all study subjects will receive the study treatment intervention. Dose exposure will begin at 10 minutes of GZNT at the first session and progress to a maximum of thirty minutes of training by the sixth or seventh visit, and continue at thirty minutes per visit for the remainder of the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Fort Carson, Colorado, United States, 80913
- Warrior Recovery Center, Bldg 1040
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Mild to Moderate Traumatic brain injury patients at least three months and not more than 5 years post-injury with recovery to a Rancho los Amigos level of seven or eight (alert and oriented);
Brain injury documented in the medical record by a history of an injury event and at least one of the following:
- loss of consciousness of any duration after the injury event;
- post-traumatic amnesia after the injury event;
- alteration in mental status (dazed/confused) after the injury event;
- physical evidence of brain trauma (MRI/CT hemorrhage/contusion);
- Persistent symptoms thought to be related to or co morbid with the brain injury event, to include two or more complaints related to problems with attention, memory, concentration, speed of processing, judgment, executive control, depression, anxiety, agitation, irritability, impulsivity, or aggression, headaches, and sleep disturbance;
- Evidence of emotional problems as defined by scores on the Post-Traumatic Stress Disorder Checklist, Military version (PCL-M) of 33 or more, or 9 or more on the Patient Health Questionnaire (PHQ-9);
- Military or Veteran beneficiary;
- Males and females aged 18-50.
Exclusion Criteria:
- Current/prior (last six months) unstable medical or psychiatric condition that could confound the effect of the TBI event on brain function (e.g. clear anoxic episode, cardiac arrest, current uncontrolled diabetes, psychosis)
- A previous history of severe TBI prior to the current injury;
- Current (last three months) active suicidal or homicidal ideation or intent;
- Current (last month) drug/alcohol abuse or dependence as determined by clinical assessment in addition to the AUDIT-C screening tool. Patients with problem drinking as defined by a score of 6 or higher on the AUDIT-C will not be eligible to participate due to concerns regarding the neurotoxic effects of alcohol following TBI. Those with scores of 4 or 5 will be counseled to reduce their intake of alcohol during the time course of the study, and a clinical determination will be made by the PI or Sub-I as to whether they can be included in the study.
- Use of certain medications due to potential interference with assessments and treatment response: benzodiazepines - excluded; narcotic analgesics - allowed only if occasional use, and not within 24 hrs of any evaluation or treatment session; nootropic medications - excluded.
- Participation in a concurrent drug or treatment trial;
- Any physical impairment that prevents the patient from being able to complete the assessment or treatment tasks (including sensory functions) or failure on effort measures at baseline evaluation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Arm
The experimental intervention in this study, Global Z-Score Neurofeedback Training, is a non-pharmacological EEG Biofeedback training process using a specific new technology that allows for the training to be semi-automated and to train based on referencing EEG activity in 19 sites on the scalp, whilst comparing in real time to a database of non-clinical normative EEG data. Subjects will be scheduled to receive 20 treatment sessions of GZNT over a six-week period, aiming for four treatment visits per week, but allowing for some missed appointments due to holidays and duty obligations. Training will be conducted for a continuous time which will begin at 10 minutes in the first session, and progress to a maximum of 30 minutes by the sixth or seventh session, and then remain at 30 minutes of training per session for the remainder of the sessions. |
The experimental intervention in this study, Global Z-Score Neurofeedback Training, is a non-pharmacological EEG Biofeedback training process using a specific new technology that allows for the training to be semi-automated and to train based on referencing EEG activity in 19 sites on the scalp, whilst comparing in real time to a database of non-clinical normative EEG data. Subjects will be scheduled to receive 20 treatment sessions of GZNT over a six-week period, aiming for four treatment visits per week, but allowing for some missed appointments due to holidays and duty obligations. Training will be conducted for a continuous time which will begin at 10 minutes in the first session, and progress to a maximum of 30 minutes by the sixth or seventh session, and then remain at 30 minutes of training per session for the remainder of the sessions. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Altered Electrocortical Patterns
Time Frame: 3 months post treatment
|
EEG measures - Global Z-Score metric for 5 variables in 4 frequency bands - measure std diff within subject and for group
|
3 months post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects on Attention
Time Frame: 3 months post treatment
|
Event-Related Potentials, Event-Related DeSynchronization patterns, and Behavioral Response Data from Attention Network Task
|
3 months post treatment
|
Effects on Memory
Time Frame: 3 months post treatment
|
WAIS-IV Letter Number Sequencing, HVLT-R (auditory), BVMT-R (visual), WMS-IV Logical Memory test.
|
3 months post treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Renee M Pazdan, MD, The Defense and Veterans Brain Injury Center
Publications and helpful links
General Publications
- Hershaw JN, Hill-Pearson CA, Arango JI, Souvignier AR, Pazdan RM. Semi-Automated Neurofeedback Therapy for Persistent Postconcussive Symptoms in a Military Clinical Setting: A Feasibility Study. Mil Med. 2020 Mar 2;185(3-4):e457-e465. doi: 10.1093/milmed/usz335.
- Hershaw J, Hill-Pearson CA, Arango JI, Souvignier AR, Pazdan RM. Changes in attentional processing following neurofeedback in patients with persistent post-concussive symptoms: a pilot study. Brain Inj. 2020 Dec 5;34(13-14):1723-1731. doi: 10.1080/02699052.2020.1812720. Epub 2020 Nov 16.
- Hershaw JN, Hill-Pearson CA. Changes in EEG Activity Following Live Z-Score Training Predict Changes in Persistent Post-concussive Symptoms: An Exploratory Analysis. Front Neurol. 2022 Mar 21;13:714913. doi: 10.3389/fneur.2022.714913. eCollection 2022.
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
- W91YTZ-13-P-0703
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
-
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
-
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
-
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
-
Institut National de la Santé Et de la Recherche...Institut National de Recherche en Informatique et en AutomatiqueNot yet recruitingTBI (Traumatic Brain Injury)France
-
BrainScope Company, Inc.RecruitingTBI (Traumatic Brain Injury) | Concussion, Brain | MTBI - Mild Traumatic Brain Injury | Closed Head InjuryUnited States
-
University of Sao Paulo General HospitalUnknownTraumatic Brain Injury | Severe Brain Injury | Closed Traumatic Brain InjuryBrazil
-
Queen Mary University of LondonCompleted
-
Northeastern UniversityBrandeis UniversityRecruitingTraumatic Brain Injury | Mild Traumatic Brain Injury | TBI | Moderate Traumatic Brain InjuryUnited States
Clinical Trials on Global Z-Score Neurofeedback Training
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingHead and Neck CarcinomaUnited States
-
Karolinska InstitutetRegion Stockholm; Stiftelsen Sunnerdahls Handikappfond; Swedish Foundation for... and other collaboratorsCompletedAttention Deficit DisorderSweden
-
Jürgen WeissUnknown
-
University Hospital, LimogesCompletedSjogren's Syndrome | Digestive System AbnormalitiesFrance
-
University of HartfordCompleted
-
Taipei Medical UniversityRecruiting
-
Chang Gung Memorial HospitalNot yet recruitingPost Operative Pain | Pain, Shoulder
-
University of MinnesotaCompletedDepression | Suicide, Attempted | Suicide, IdeationUnited States
-
Osaka UniversityJapan Agency for Medical Research and DevelopmentUnknown
-
Leiden University Medical CenterCompletedElevated EEG Theta/Beta Ratio