Post-Concussion SymptomsCeresetNCT03649958
Neurotechnology Following Traumatic Brain Injury
A study testing HIRREM-SOP or Cereset and Cereset 2x in people with Post-Concussion Symptoms and Insomnia, run by Brain State Technologies, LLC at 2 sites in United States.
Trial summary
This two-part study seeks to improve symptoms such as pain and sleep problems after concussion, or mild traumatic brain injury (mTBI). Study I evaluates symptoms of mTBI through a series of 10 office sessions in which musical tones are echoed, or mirrored back in real time, to reflect one's own brain activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Concussion Symptoms, Insomnia, Pain, Chronic
- What is being tested?
- HIRREM-SOP or Cereset and Cereset 2x
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Aug 2018to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 Must have symptoms related to concussion or TBI, not healthy controls Age 18 years or older.
- 2 Active duty or retired military service member, or dependent beneficiary.
- 3 History of mild TBI, confirmed by administration of the Ohio State University TBI
- Identification Method Interview.
- 4 At least three months, and no more than ten years, since their most recent TBI.
- 5 Persistent symptoms temporally related, or otherwise attributable to, the TBI, such as
Show all 33Show fewer
- headache or chronic pain, sensory disturbance including auditory, visual or other sensory
- symptoms, balance difficulties, or dizziness. After obtaining informed consent, sufficient
- severity of symptoms for entry into the study will be confirmed by administration of the
- Neurobehavioral Symptom Inventory (NSI), with a score of 23 or higher required for
- 6 Willingness to be randomly assigned to one of the two treatment groups and to provide
- data for all study measures.
- 7 Willingness to abstain from alcohol or recreational drug use throughout the intervention
- period and up to 3 weeks after completion of the final office-based intervention session.
- This abstention period is intended to support the stabilization of new brain activity
- patterns that may result from the intervention.
- 8 For individuals using any of the following medication classes (either regularly scheduled
- or PRN), a willingness both to discontinue or hold those medications at least five (5) halflives
- prior to the initiation of study procedures, and throughout the period of participation
- in the study, as well as to sign a release enabling contact between study staff and their
- prescribing provider, to ensure that the prescriber deems that holding said medication
- during the study period is permissible and reasonable: benzodiazepines, opioids, antipsychotics,
- mood-stabilizers, anti-convulsants, non-benzodiazepine sleep aids (including
- but not limited zolpidem, eszoplicone, zaleplon, trazadone, and diphenhydramine), other
- prescribed sedative-hypnotics, or medical marijuana or cannabinoid medication.
- 9 Willingness to abstain from initiation of PRN/as needed usage of the above listed
- medications throughout the period of study participation. This criterion only applies to
- new PRN prescription or usage. There is no requirement to abstain from a new, regularly scheduled prescription for one of the above medications during the course of the study, if the participant's provider
- deems such usage to be indicated. The potential impact of the initiation of any such
- medications during the study will be assessed by conducting sensitivity analyses after the
- completion of the study.
- 10 Willingness to alert study investigators of any changes in their medication usage
- throughout the course of their study participation.
Who cannot join
- 1 Unable or unwilling to demonstrate an understanding of the nature and intent of the
- study, and/or to complete informed consent procedures.
- 2 A history of moderate or severe TBI.
- 3 The diagnosis of a psychotic disorder (including schizophrenia and schizoaffective
- disorder), severe depression (PHQ-9 score > 20), bipolar disorder, or active suicidal or
- homicidal ideation.
Show all 9Show fewer
- 4 Physically unable to come to the study visits, or to sit in a chair for up to two hours.
- 5 Inability to hear and repeat a phrase spoken at normal conversational volume.
- 6 Meeting criteria for a current alcohol or substance use disorder.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Uniformed Services University
Bethesda, Maryland, 20814
Womack Army Medical Center
Fort Bragg, North Carolina, 28310
About this study
Official title: Randomized Controlled Trials of Closed-loop Allostatic Neurotechnology to Improve Sensory Function and Pain Management After Traumatic Brain Injury
This two-part study seeks to improve symptoms such as pain and sleep problems after concussion, or mild traumatic brain injury (mTBI).
Study I evaluates symptoms of mTBI through a series of 10 office sessions in which musical tones are echoed, or mirrored back in real time, to reflect one's own brain activity. Those who take part in the study will be randomly assigned to receive either tones that are based on their brain activity/brainwaves, or random tones.
Study II evaluates symptoms of mTBI through either 10 office sessions of the same acoustic stimulation linked to brain activity/brainwaves as Study I compared to 5 office sessions of acoustic stimulation plus intermittent very low level electrical stimulation of the scalp linked to brain activity.
Read the detailed description
Persistent symptoms after concussion or mild traumatic brain injury (mTBI), such as pain and sleep difficulties, may be related to altered patterns of brain electrical activity, including changes in amplitude and frequency. The purpose of these two studies is to evaluate a noninvasive, closed-loop, acoustic stimulation neurotechnology, High resolution, relational, resonance-based, electroencephalic mirroring, with standard operating procedures, HIRREM-SOP. This intervention is intended to improve symptoms by supporting self-optimization of brain electrical activity. Put more simply, musical tones will be played to echo, or mirror one's own brainwaves, in real time, allowing opportunity for auto-calibration, self-adjustment, and equilibration of that brain activity. The hypothesis is that over the course of ten 90-minute sessions, symptoms related to mTBI, will improve much more with musical tones linked to brainwaves than with random tones.
Participants will be enrolled at Uniformed Services University/Walter Reed National Military Medical Center in Bethesda, MD, and Womack Army Medical Center, Fort Bragg, NC.
The 106 participants in the first part of the study can be active duty or recently retired service members, or their family members, who have had a mTBI at least three months and not more than ten years ago, with related symptoms. Participants will be randomized to either musical tones that reflect their own brain activity, or random tones. A technologist will oversee each session in which the tones are presented. Participants and those analyzing outcomes will be blinded to the nature of the acoustic stimuli received. The primary outcome will be the change in Neurobehavioral Symptom Inventory scores at three months, and the final follow-up will occur be at six months. Changes in sleep, pain, dizziness, and general quality of life will also be measured.
Study II will recruit up to 100 participants with the goal of randomizing 86 participants to one of the two interventional arms equally across the same locations with the same inclusions criteria. This study seeks to establish a non-inferiority for the shorter course intervention. The primary outcome measure will continue to be the NSI score measured post-intervention and at 3-months. Changes in sleep, pain, dizziness, and general quality of life will also be measured.
- Conditions
- Post-Concussion Symptoms, Insomnia, Pain, Chronic, Depressive Symptoms
- Being tested
- HIRREM-SOP or Cereset, Cereset 2x
- Keywords
- concussion, mTBI, headache, insomnia, PTS, anxiety, pain, depression, sleep
- Medical subject headings
- Post-Concussion Syndrome, Sleep Initiation and Maintenance Disorders, Chronic Pain, Depression, Brain Concussion, Headache, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIRREM-SOP or CeresetDevice
HIRREM-SOP for ten 90 minute sessions
Cereset 2xDevice
Cereset 2x for five 90 minute sessions
| Study group | Role | What they receive |
|---|---|---|
| HIRREM-SOP or Cereset | Active comparator | 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. Receives: Device: HIRREM-SOP or Cereset |
| Cereset 2x | Active comparator | 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, Receives: Device: Cereset 2x |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurobehavioral Symptom Inventory (NSI)
0 = None - Rarely if ever present; not a problem at all and 4= Very Severe - Almost always present and I have been unable to perform at work, school or home due to this problem; I probably cannot function without help.
Measured: decrease in the score three months following enrollment
Secondary outcomes (5)
PATIENT'S GLOBAL IMPRESSION OF CHANGE (PGIC) SCALE
- No change (or condition has gotten worse) (1); to
- A great deal better and a considerable improvement that has made all the difference (7)
Measured: Score increases three months after enrollment
HIT-6 Headache Impact Test
based on scale from never (6 pts) to always (13 pts)
Measured: improve headache patterns by decreasing point score 3 months after enrollment
The Dizziness Handicap Inventory ( DHI )
To each item, the following scores can be assigned:
No=0 Sometimes=2 Yes=4
Scores:
Scores greater than 10 points should be referred to balance specialists for further evaluation.
16-34 Points (mild handicap) 36-52 Points (moderate handicap) 54+ Points (severe handicap) Scores are assigned No=0 Sometimes=2 Yes=4; total greater than 10 requires further evaluation and 54+ severe handicap
Measured: Lower the point total for those whose base line is greater than 10 pts at evaluation 3 months following enrollment
PCL-5 The PTSD Checklist for DSM-5
Questions scored as 0=not at all; to, 4=Extremely
Measured: Lower the score three months after enrollment
Patient Health Questionnaire-9 (PHQ-9)
Frequency of being bothered by the conditions where 0=not at all; to 3=nearly every day
Measured: Lower the score three months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start28 Aug 2018
- Primary completion30 Sep 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-Concussion SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain State Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Uniformed Services University of the Health Sciences, Womack Army Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649958
- Sponsor's protocol ID
- MED-83-8754
- Other IDs
- W81XWH1720057
- Acronym
- Cereset
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2018
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tegeler CL, Haight TJ, Cole WR, Shaltout HA, Choi YS, Harris TE, Rachels N, Bellini PG, Roy MJ, Tegeler CH. Acoustic neuromodulation with or without micro-voltage tACS reduces post-concussive symptoms. Brain Inj. 2025 May 12;39(6):496-508. doi: 10.1080/02699052.2024.2445709. Epub 2025 Feb 6.
PubMed 39913294Cole WR, Tegeler CL, Choi YS, Harris TE, Rachels N, Bellini PG, Haight TJ, Gerdes L, Tegeler CH, Roy MJ. Randomized, controlled clinical trial of acoustic stimulation to reduce postconcussive symptoms. Ann Clin Transl Neurol. 2024 Jan;11(1):105-120. doi: 10.1002/acn3.51937. Epub 2023 Nov 22.
PubMed 37990636
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trials of Closed-loop Allostatic Neurotechnology to Improve Sensory Function and Pain Management After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03649958
- Acronym / sponsor ID
- Cereset / MED-83-8754
- Conditions
- Post-Concussion Symptoms, Insomnia, Pain, Chronic, Depressive Symptoms
- Keywords
- concussion, mTBI, headache, insomnia, PTS, anxiety, pain, depression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Brain State Technologies, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Uniformed Services University of the Health Sciences, Womack Army Medical Center
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 28 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This two-part study seeks to improve symptoms such as pain and sleep problems after concussion, or mild traumatic brain injury (mTBI).
Study I evaluates symptoms of mTBI through a series of 10 office sessions in which musical tones are echoed, or mirrored back in real time, to reflect one's own brain activity. Those who take part in the study will be randomly assigned to receive either tones that are based on their brain activity/brainwaves, or random tones.
Study II evaluates symptoms of mTBI through either 10 office sessions of the same acoustic stimulation linked to brain activity/brainwaves as Study I compared to 5 office sessions of acoustic stimulation plus intermittent very low level electrical stimulation of the scalp linked to brain activity.
Detailed description
Persistent symptoms after concussion or mild traumatic brain injury (mTBI), such as pain and sleep difficulties, may be related to altered patterns of brain electrical activity, including changes in amplitude and frequency. The purpose of these two studies is to evaluate a noninvasive, closed-loop, acoustic stimulation neurotechnology, High resolution, relational, resonance-based, electroencephalic mirroring, with standard operating procedures, HIRREM-SOP. This intervention is intended to improve symptoms by supporting self-optimization of brain electrical activity. Put more simply, musical tones will be played to echo, or mirror one's own brainwaves, in real time, allowing opportunity for auto-calibration, self-adjustment, and equilibration of that brain activity. The hypothesis is that over the course of ten 90-minute sessions, symptoms related to mTBI, will improve much more with musical tones linked to brainwaves than with random tones.
Participants will be enrolled at Uniformed Services University/Walter Reed National Military Medical Center in Bethesda, MD, and Womack Army Medical Center, Fort Bragg, NC.
The 106 participants in the first part of the study can be active duty or recently retired service members, or their family members, who have had a mTBI at least three months and not more than ten years ago, with related symptoms. Participants will be randomized to either musical tones that reflect their own brain activity, or random tones. A technologist will oversee each session in which the tones are presented. Participants and those analyzing outcomes will be blinded to the nature of the acoustic stimuli received. The primary outcome will be the change in Neurobehavioral Symptom Inventory scores at three months, and the final follow-up will occur be at six months. Changes in sleep, pain, dizziness, and general quality of life will also be measured.
Study II will recruit up to 100 participants with the goal of randomizing 86 participants to one of the two interventional arms equally across the same locations with the same inclusions criteria. This study seeks to establish a non-inferiority for the shorter course intervention. The primary outcome measure will continue to be the NSI score measured post-intervention and at 3-months. Changes in sleep, pain, dizziness, and general quality of life will also be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| HIRREM-SOP or Cereset | Active comparator | Device: HIRREM-SOP or CeresetHIRREM-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. |
| Cereset 2x | Active comparator | Device: Cereset 2xParticipants 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, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- 1 Must have symptoms related to concussion or TBI, not healthy controls Age 18 years or older.
- 2 Active duty or retired military service member, or dependent beneficiary.
- 3 History of mild TBI, confirmed by administration of the Ohio State University TBI
- Identification Method Interview.
- 4 At least three months, and no more than ten years, since their most recent TBI.
Key exclusion criteria (9 listed)
- 1 Unable or unwilling to demonstrate an understanding of the nature and intent of the
- study, and/or to complete informed consent procedures.
- 2 A history of moderate or severe TBI.
- 3 The diagnosis of a psychotic disorder (including schizophrenia and schizoaffective
- disorder), severe depression (PHQ-9 score > 20), bipolar disorder, or active suicidal or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIRREM-SOP or CeresetHIRREM-SOP for ten 90 minute sessions | Device | HIRREM-SOP or Cereset |
| Cereset 2xCereset 2x for five 90 minute sessions | Device | Cereset 2x |
Primary outcome
Neurobehavioral Symptom Inventory (NSI)
Time frame: decrease in the score three months following enrollment
0 = None - Rarely if ever present; not a problem at all and 4= Very Severe - Almost always present and I have been unable to perform at work, school or home due to this problem; I probably cannot function without help.
5 secondary outcomes
PATIENT'S GLOBAL IMPRESSION OF CHANGE (PGIC) SCALE
Time frame: Score increases three months after enrollment
HIT-6 Headache Impact Test
Time frame: improve headache patterns by decreasing point score 3 months after enrollment
The Dizziness Handicap Inventory ( DHI )
Time frame: Lower the point total for those whose base line is greater than 10 pts at evaluation 3 months following enrollment
PCL-5 The PTSD Checklist for DSM-5
Time frame: Lower the score three months after enrollment
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Lower the score three months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Derived from this study: PubMed 39913294Tegeler CL, Haight TJ, Cole WR, Shaltout HA, Choi YS, Harris TE, Rachels N, Bellini PG, Roy MJ, Tegeler CH. Acoustic neuromodulation with or without micro-voltage tACS reduces post-concussive symptoms. Brain Inj. 2025 May 12;39(6):496-508. doi: 10.1080/02699052.2024.2445709. Epub 2025 Feb 6.
- Derived from this study: PubMed 37990636Cole WR, Tegeler CL, Choi YS, Harris TE, Rachels N, Bellini PG, Haight TJ, Gerdes L, Tegeler CH, Roy MJ. Randomized, controlled clinical trial of acoustic stimulation to reduce postconcussive symptoms. Ann Clin Transl Neurol. 2024 Jan;11(1):105-120. doi: 10.1002/acn3.51937. Epub 2023 Nov 22.
- Individual participant dataSharing planned: No
Related trials for Post-Concussion Symptoms
Not yet recruiting
Electroencephalography Markers of Brain Stimulation in Post-Concussion Patients
Patients With Persistent Post-concussion Symptoms
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
Recruiting
Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury
Traumatic Brain Injury
Active, not recruiting
Move&Connect: A Program for Youth With Concussion and Their Caregivers.
Post-Concussion Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIRREM-SOP or Cereset and Cereset 2x in people with Post-Concussion Symptoms and Insomnia, run by Brain State Technologies, LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurobehavioral Symptom Inventory (NSI) (time frame: decrease in the score three months following enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03649958, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.