Neurofeedback Technology (GZNT) for Persistent Post-Concussive Symptoms in Soldiers
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Post-Concussion Syndrome
Study type: Interventional

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.
    

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.
    

Intervention name(s): Global Z-Score Neurofeedback Training
Intervention type(s): Behavioral
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mTBI; cognition disorders; post-concussive syndrome; neuroplasticity; EEG; biofeedback; stress disorder/post-traumatic; depression