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Gamma Wave Therapy for Traumatic Brain Injury (DAGABBI Trial)
N/A
Recruiting
Led By Kevin M. Spencer, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 18-65 years
Be older than 18 years old
Must not have
Cognitive disorder due to general medical condition other than TBI
Self-reported severe depression or anxiety requiring hospitalization overnight, or current active homicidal and/or suicidal ideation with intent requiring crisis intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minutes
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether using gamma waves can help improve symptoms for veterans who have experienced blast-related brain injuries.
Who is the study for?
This trial is for post-9/11 combat veterans aged 18-65 who have experienced blast exposure and are part of the VA Boston Healthcare System. It includes those exposed to blasts from less than or more than 10 meters away, with groups matched by age and gender. Veterans must not have severe mental health issues, neurological illnesses, substance abuse problems, or hearing impairments.
What is being tested?
The study tests auditory gamma sensory stimulation as a potential treatment for cognitive and emotional problems caused by blast-related brain injuries in veterans. The focus is on detecting and improving abnormalities in brain wave patterns known as gamma oscillations.
What are the potential side effects?
Since this trial involves non-invasive auditory stimulation rather than medication, traditional side effects like you might see with drugs are not expected. However, participants may experience discomfort or other sensations related to the auditory stimulus.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a cognitive disorder not caused by traumatic brain injury.
Select...
I have severe depression or anxiety that required hospitalization or have had serious thoughts of harming myself or others.
Select...
I have a history of neurological illnesses like Huntington's or Parkinson's.
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I have had seizures not caused by a head injury.
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I have been diagnosed with schizophrenia, bipolar, or another psychotic disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in evoked gamma power of conditioned vs. unconditioned tones
Change in spontaneous gamma power
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: All participantsExperimental Treatment1 Intervention
All participants receive auditory gamma sensory stimulation.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,733 Total Patients Enrolled
Kevin M. Spencer, PhDPrincipal InvestigatorVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been exposed to a sudden, intense burst of energy or pressure, like from an explosion.I have a cognitive disorder not caused by traumatic brain injury.Half of the participants have been close to an explosion within 10 meters.I am between 18 and 65 years old.I have severe depression or anxiety that required hospitalization or have had serious thoughts of harming myself or others.This means there are more rules about who can't join the study.You have struggled with alcohol or drug addiction in the past 6 months.My age and gender will be matched with others in the study.I have a history of neurological illnesses like Huntington's or Parkinson's.I have had seizures not caused by a head injury.You have trouble hearing according to a hearing test.You have a mental health condition that might make it hard to collect accurate information, as decided by at least three psychologists with a doctoral-level degree.Half of the participants must have been far away (more than 10 meters) from a blast.I have been diagnosed with schizophrenia, bipolar, or another psychotic disorder.Initial exclusion criteria for TRACTS are:
Research Study Groups:
This trial has the following groups:- Group 1: All participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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