Detection and Amelioration of Gamma Oscillation Abnormalities in Blast-Related Brain Injury

NCT03836976 | Recruiting

• 2 other identifiers: N3162-PI21RX003162
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Combat Veterans of post-9/11 conflicts have experienced serious cognitive and emotional problems resulting from exposure to blasts. Recent work suggests that a critical factor influencing the consequences of blast exposure is distance from the blast, rather than the presence or absence of concussion symptoms. Exposure to blasts from a distance of \<10 m has been associated with significantly greater cognitive and neural problems than exposure to blasts from \>10 m. So far, the effects of blast-related brain injury on the brain are poorly understood, as to date the effects of blast exposure have received little research focus. The investigators propose to use oscillations in the gamma band (30-100 Hz) of the electroencephalogram (EEG; brain waves) to detect and remediate neural circuit dysfunction related to blast injury in Veterans. If successful, this project could lead to new approaches to detect and remediate the effects of blast exposure on Veterans and aid in their functional recovery.

Conditions

mTBI

Keywords

mild traumatic brain injury; EEG; neuroplasticity; gamma oscillation

Outcome Measures

Primary Outcomes (4)

• Change in evoked gamma power of conditioned vs. unconditioned tones

  Evoked power of the early auditory-evoked gamma oscillation for conditioned vs. unconditioned tones relative to baseline at 0 min after conditioning stimulation.

  0 minutes

• Change in evoked gamma power of conditioned vs. unconditioned tones

  Evoked power of the early auditory-evoked gamma oscillation for conditioned vs. unconditioned tones relative to baseline at 20 min after conditioning stimulation.

  20 minutes

• Change in spontaneous gamma power

  Spontaneous broadband gamma power relative to baseline at 0 min after conditioning stimulation.

  0 minutes

• Change in spontaneous gamma power

  Spontaneous broadband gamma power relative to baseline at 20 min after conditioning stimulation.

  20 minutes

Study Arms (1)

All participants

EXPERIMENTAL

All participants receive auditory gamma sensory stimulation.

Other: Auditory gamma sensory stimulation

Interventions

Auditory gamma sensory stimulation OTHER

Gamma-conditioning stimulation will be administered in 2 blocks of 3 min each. During each block, participants will be presented with a continuous tone at the CF (500 or 1200 Hz) that will be amplitude modulated at 40 H

All participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Research participants will be 50 veterans
• Ages 18-65 years
• Have experienced blast exposure
• Recruited from the VA Translational Research Center for TBI and Stress Disorders (TRACTS) at the VA Boston Healthcare System (VABHS)
• Half of the participants will have experienced blast exposure from a Close distance (\<10 m)
• Half of the participants will have experienced blast exposure from a Far distance (\>10 m)
• These groups will be matched on age and female/male ratio

You may not qualify if:

• History of neurological illness
• Huntington's
• Parkinson's
• dementia, etc
• History of seizure disorders unrelated to head injury
• Current diagnosis of schizophrenia, bipolar, or other psychotic disorder
• Self-reported severe depression or anxiety requiring hospitalization overnight, or current active homicidal and/or suicidal ideation with intent requiring crisis intervention
• Cognitive disorder due to general medical condition other than TBI
• Unstable psychological diagnosis (suspected psychotic or personality disorder) that would interfere with accurate data collection, determined by consensus of at least three doctoral-level psychologists.
• Current alcohol or drug dependence, or abuse within the last 6 months (DSM-IV criteria)
• Hearing impairments as assessed by audiometry

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Kevin M. Spencer, PhD

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin M Spencer, PhD

CONTACT

(774) 826-1375; Kevin.Spencer@va.gov

Study Design

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

Model Details: Single arm. All participants will receive auditory gamma-frequency sensory stimulation.

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 11, 2019
• Study Start: December 2, 2019
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)