Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neurofeedback Technology (GZNT) for Persistent Post-Concussive Symptoms in Soldiers (GZNT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02509689
Recruitment Status : Active, not recruiting
First Posted : July 28, 2015
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
The Defense and Veterans Brain Injury Center

Brief Summary:
A new technology called Global Z-Score Neurofeedback Technology (GZNT) has been identified that can overcome an existing barrier to the use of neurofeedback as a treatment technique in a military setting. Neurofeedback, or EEG Biofeedback, is a form of biofeedback that uses the brain's own electrical activity as the training parameter. With sufficient practice, the brain can learn to change its own activity through finely tuned feedback using computerized sounds, graphs and animations. Previous attempts at using neurofeedback as a treatment modality have been subject to a lack of standardization and have required significant expertise on the part of the provider. This new GZNT technology allows neurofeedback to be administered in a standardized and semi-automated fashion, which, if effective, will represent a significant advance toward providing this promising treatment modality to Service Members in a military or VA setting. This study will determine feasibility and preliminary evidence of efficacy for this neurofeedback technology in a pilot study of soldiers with medical issues associated with Traumatic Brain Injury (TBI). GZNT technology has the potential to provide a cost-efficient, non-invasive/non-pharmacological approach to recovery from impact and/or blast-induced brain injury, and holds promise to simultaneously address emotional symptoms that are often a part of the post-concussion symptom picture.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Behavioral: Global Z-Score Neurofeedback Training Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of a Novel Neurofeedback Technology (GZNT) for Persistent Post-Concussive Symptoms in Soldiers
Actual Study Start Date : December 2014
Actual Primary Completion Date : October 2017
Estimated Study Completion Date : July 2019

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.

Behavioral: Global Z-Score Neurofeedback Training

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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Effects on Attention [ Time Frame: 3 months post treatment ]
    Event-Related Potentials, Event-Related DeSynchronization patterns, and Behavioral Response Data from Attention Network Task

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509689


Locations
Layout table for location information
United States, Colorado
Warrior Recovery Center, Bldg 1040
Fort Carson, Colorado, United States, 80913
Sponsors and Collaborators
The Defense and Veterans Brain Injury Center
Investigators
Layout table for investigator information
Principal Investigator: Renee M Pazdan, MD The Defense and Veterans Brain Injury Center

Layout table for additonal information
Responsible Party: The Defense and Veterans Brain Injury Center
ClinicalTrials.gov Identifier: NCT02509689     History of Changes
Other Study ID Numbers: W91YTZ-13-P-0703
First Posted: July 28, 2015    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

Keywords provided by The Defense and Veterans Brain Injury Center:
mTBI
cognition disorders
post-concussive syndrome
neuroplasticity
EEG
biofeedback
stress disorder/post-traumatic
depression

Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Post-Concussion Syndrome
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Concussion
Head Injuries, Closed
Wounds, Nonpenetrating