Neurofeedback Technology (GZNT) for Persistent Post-Concussive Symptoms in Soldiers (GZNT)
Traumatic Brain Injury
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring mTBI, cognition disorders, post-concussive syndrome, neuroplasticity, EEG, biofeedback, stress disorder/post-traumatic, depression
Eligibility 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.
Sites / Locations
- Warrior Recovery Center, Bldg 1040
Arms of the Study
Arm 1
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.