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

NCT02509689 | Completed

• 1 other identifier: W91YTZ-13-P-0703
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

mTBI; cognition disorders; post-concussive syndrome; neuroplasticity; EEG; biofeedback; stress disorder/post-traumatic; depression

Outcome Measures

Primary Outcomes (1)

• Altered Electrocortical Patterns

  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 Outcomes (2)

• Effects on Attention

  3 months post treatment

• Effects on Memory

  3 months post treatment

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Interventions

Global Z-Score Neurofeedback Training BEHAVIORAL

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.

Single Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Defense and Veterans Brain Injury Center: lead

Study Sites (1)

Warrior Recovery Center, Bldg 1040

Fort Carson, Colorado, 80913, United States

Location

Related Publications (3)

• 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.

  PMID: 31603218 RESULT

• 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.

  PMID: 33196305 RESULT

• 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.

  PMID: 35392637 RESULT

Related Links

• Changes in EEG Activity Following Live Z-Score Training Predict Changes in Persistent Post-concussive Symptoms: An Exploratory Analysis

MeSH Terms

Conditions

Brain Injuries, Traumatic; Cognition Disorders; Post-Concussion Syndrome; Combat Disorders; Depression

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurocognitive Disorders; Mental Disorders; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Behavioral Symptoms; Behavior

Study Officials

• Renee M Pazdan, MD

  The Defense and Veterans Brain Injury Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: July 28, 2015
• Study Start: December 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: March 1, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-03

Locations

US (1)