Neurotechnology for Traumatic Brain Injury
(Cereset Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Brain State Technologies, LLC

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests if playing musical tones that mirror brain activity can help service members and their families with mild traumatic brain injury (mTBI) improve symptoms like pain and sleep problems. The tones help the brain recognize its own activity and make adjustments to function better. Music therapy has shown promising results in improving cognitive and motor functions in patients with traumatic brain injury (TBI).

Eligibility Criteria

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.

Inclusion Criteria

Identification Method Interview.

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.

+17 more

Exclusion Criteria

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.

+3 more

Participant Groups

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.

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.