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Neurotechnology
Neurotechnology for Traumatic Brain Injury (Cereset Trial)
N/A
Waitlist Available
Research Sponsored by Brain State Technologies, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have symptoms related to concussion or TBI, not healthy controls Age 18 years or older.
1 Must have symptoms related to concussion or TBI, not healthy controls Age 18 years or older.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up lower the score three months after enrollment
Awards & highlights
Cereset Trial Summary
This trial is testing a new treatment for concussion symptoms that involves 10 sessions of mirroring brain waves with musical tones, or 5 sessions of that plus electrical stimulation.
Who is the study for?
This trial is for adults over 18 who've had a mild traumatic brain injury (mTBI) between 3 months and 10 years ago, with persistent symptoms like pain or sensory issues. It's open to military members, retirees, or their dependents. Participants must not use alcohol/recreational drugs during the study and be willing to pause certain medications.Check my eligibility
What is being tested?
The study tests two interventions: Cereset sessions where musical tones mirror one's brain activity, and HIRREM-SOP which adds low-level electrical scalp stimulation. Participants are randomly assigned to either just acoustic stimulation or combined with electrical stimulation across multiple sessions.See study design
What are the potential side effects?
Potential side effects aren't specified but may include discomfort from wearing headgear for acoustic and electrical stimulation, possible headaches or dizziness post-session due to changes in brain activity patterns.
Cereset Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older with symptoms from a concussion or TBI.
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I am 18 or older with symptoms from a concussion or TBI.
Select...
I have ongoing symptoms like headaches or dizziness due to a brain injury.
Select...
I have symptoms like headaches or dizziness due to a brain injury, confirmed by a test score of 23 or higher.
Select...
My last traumatic brain injury was between 3 months and 10 years ago.
Select...
I am 18 or older with symptoms from a concussion or TBI.
Cereset Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ decrease in the score three months following enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~decrease in the score three months following enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neurobehavioral Symptom Inventory (NSI)
Secondary outcome measures
HIT-6 Headache Impact Test
PATIENT'S GLOBAL IMPRESSION OF CHANGE (PGIC) SCALE
PCL-5 The PTSD Checklist for DSM-5
+2 moreOther outcome measures
Automated Neuropsychological Assessment Metrics (ANAM)
Defense and Veterans Pain Rating Scale
Insomnia Severity Index
Cereset Trial Design
2Treatment groups
Active Control
Group I: Cereset 2xActive Control1 Intervention
Participants randomized to the Cereset 2x group will be seated in a comfortable zero-gravity chair identical to those in the HIRREM-SOP arm. They will listen to a pattern of musical notes linked to their brain activity patterns, but also receive intermittent very low level electrical stimulation of the scalp linked to brain activity. This group will only have 5 sessions,
Group II: HIRREM-SOP or CeresetActive Control1 Intervention
HIRREM-SOP is a novel, noninvasive, closed-loop, BrainEcho, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time. This group will have 10 sessions.
Find a Location
Who is running the clinical trial?
Brain State Technologies, LLCLead Sponsor
1 Previous Clinical Trials
32 Total Patients Enrolled
Womack Army Medical CenterFED
18 Previous Clinical Trials
16,215 Total Patients Enrolled
Uniformed Services University of the Health SciencesFED
116 Previous Clinical Trials
91,336 Total Patients Enrolled
1 Trials studying Chronic Pain
716 Patients Enrolled for Chronic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to avoid alcohol and drugs during and 3 weeks after the study.I agree not to start any as-needed medications listed by the study while participating.It's been 3 months to 10 years since my last traumatic brain injury.I experience headaches, chronic pain, or changes in my senses like hearing or vision.I am 18 or older with symptoms from a concussion or TBI.I am 18 or older with symptoms from a concussion or TBI.I agree to not consume alcohol or use recreational drugs during and up to 3 weeks after the study.You have had a moderate or severe traumatic brain injury in the past.I have been diagnosed with a severe mental health condition or have thoughts of harming myself or others.I cannot attend study visits or sit for up to two hours.You currently have a problem with drinking alcohol or using drugs.I am willing to stop taking certain medications, like painkillers or sleep aids, as required for the study.My last traumatic brain injury was between 3 months and 10 years ago.I have symptoms like headaches or dizziness due to a brain injury, confirmed by a test score of 23 or higher.I have ongoing symptoms like headaches or dizziness due to a brain injury.I understand the study's purpose and can give informed consent.My last traumatic brain injury was between 3 months and 10 years ago.I cannot hear and repeat phrases spoken at a normal volume.I am 18 or older with symptoms from a concussion or TBI.You have a history of mild traumatic brain injury (TBI) confirmed by a specific interview conducted by the Ohio State University.You have a history of mild traumatic brain injury confirmed by a test from Ohio State University.You are currently serving or have served in the military, or are a family member of someone who has served.
Research Study Groups:
This trial has the following groups:- Group 1: Cereset 2x
- Group 2: HIRREM-SOP or Cereset
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical research opening its doors to participants at the present time?
"Affirmative, the online evidence indicates that recruitment is underway for this clinical trial which was initially launched on August 28th 2018. The last update was made on March 29th 2022 and 110 patients are being sought at 2 different medical sites."
Answered by AI
What is the total size of this clinical trial's subject pool?
"Affirmative. Information found on clinicaltrials.gov suggests that this medical trial is proactively recruiting participants from two different sites, with a target of 110 enrollees in total. The study was initially posted on August 28th 2018 and last amended March 29th 2022."
Answered by AI
Who else is applying?
What state do they live in?
California
Virginia
Florida
How old are they?
18 - 65
What site did they apply to?
Uniformed Services University
Womack Army Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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