What side effects are associated with this type of intervention?

Acoustic Stimulation, which involves real-time feedback of brain activity through musical tones, has not been widely reported to have significant side effects. Electrical Stimulation, such as Transcutaneous Electrical Nerve Stimulation (TENS) and other forms of neuromodulation, can cause mild side effects including a warm sensation, numbness, redness, itching, tingling, muscle spasm, and localized pain. These side effects are generally mild and transient, with no serious adverse events reported.

What prior FDA approvals exist?

The FDA has approved several neurostimulation and neuromodulation treatments for chronic pain. Transcranial magnetic stimulation (TMS) is one such treatment, approved for conditions like migraine, which involves using magnetic fields to stimulate nerve cells in the brain. Another approved method is vagus nerve stimulation (VNS), which involves electrical impulses to the vagus nerve to alleviate pain. Additionally, spinal cord stimulation (SCS) is used for chronic pain management, delivering electrical pulses to the spinal cord to block pain signals. These treatments are similar to the acoustic and electrical stimulation methods being studied, as they all involve modulating neural activity to manage pain.

What other types of research exist?

Promising novel alternatives for chronic pain treatment in 2024 include: 1) Noninvasive Vagus Nerve Stimulation (nVNS), which has shown efficacy in reducing pain through modulation of the autonomic nervous system. 2) Remote Electrical Neuromodulation (REN), which involves nonpainful electrical stimulation to alleviate pain. 3) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain and has been effective in treating various pain conditions. These methods offer non-invasive options with growing evidence of their effectiveness in pain management.

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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.

Must not have

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

Physically unable to come to the study visits, or to sit in a chair for up to two hours

Timeline

Screening 3 weeks

Treatment Varies

Follow Up lower the score three months after enrollment

Awards & highlights

No Placebo-Only Group

Summary

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).

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 or older with symptoms from a concussion or TBI.

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with a severe mental health condition or have thoughts of harming myself or others.

Select...

I cannot attend study visits or sit for up to two hours.

Select...

I cannot hear and repeat phrases spoken at a normal volume.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and decrease in the score three months following enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neurobehavioral Symptom Inventory (NSI)

Secondary study objectives

HIT-6 Headache Impact Test

PATIENT'S GLOBAL IMPRESSION OF CHANGE (PGIC) SCALE

PCL-5 The PTSD Checklist for DSM-5

+2 more

Other study objectives

Automated Neuropsychological Assessment Metrics (ANAM)

Defense and Veterans Pain Rating Scale

Insomnia Severity Index

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Acoustic Stimulation involves real-time feedback of brain activity through musical tones, which aims to modulate brain activity and potentially reduce pain perception by promoting neuroplasticity and altering pain-related neural pathways. Electrical Stimulation, such as very low-level electrical stimulation of the scalp linked to brain activity, works by directly influencing neural circuits involved in pain processing, potentially reducing pain through mechanisms like inhibition of pain signals and enhancement of endogenous pain control systems. These treatments are significant for chronic pain patients as they offer non-pharmacologic options that target the central nervous system, potentially providing relief without the side effects associated with medications.

Long-term experience of neuromodulation in TACs.