Can a personalized mix of nerve stimulation and therapy rewire the brain for better mental health?

NCT ID NCT07812987

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 17, 2026 · Updated 3 times

Summary

Researchers are testing a personalized, non-drug treatment for adults with ongoing depression, anxiety, trauma-related symptoms, sleep problems, attention difficulties, or substance-use concerns. Instead of assigning treatment by diagnosis alone, the study selects approaches based on each person's symptoms, body signals, and clinical presentation. Treatment may include noninvasive nerve stimulation, sensory stimulation, regulated breathing, and a form of psychotherapy that helps process memories. The study measures whether these personalized approaches produce rapid and lasting improvements, and whether those improvements show up in brain, heart, cognitive, and inflammatory signals.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A personalized combination of noninvasive vagus nerve stimulation, sensory stimulation, regulated breathing, and AIP-informed integrative psychotherapy
What this could lead to
If it works, this could offer a drug-free, personalized way to ease depression, anxiety, trauma symptoms, and sleep problems, and give doctors objective signals to track how well treatment is working.
What could go wrong
This is an early study with no control group, so improvements may come from the therapy itself, the passage of time, or placebo effects. The personalized approach is complex and may not work the same way for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 to 70 years at the time of consent * Able to understand the study and provide signed informed consent * Willing and able to comply with study procedures and follow-up assessments for approximately 12 months * Presence of clinically significant behavioral-health symptoms and/or functional impairment in at least one of the following domains, as determined by clinical interview and standardized measures: * Depressive symptoms * Anxiety symptoms * Trauma- and stressor-related symptoms * Substance-related symptoms not requiring immediate detoxification * Attentional/impulsivity or executive-function symptoms * A formal DSM-5 diagnosis is not required if symptoms and impairment are clinically meaningful and appropriate for outpatient behavioral-health intervention * Medically stable, in the judgment of the investigator, for outpatient behavioral-health treatment and applicable noninvasive neuromodulation or multisensory entrainment * If taking psychotropic or other relevant medications, on a stable dose for at least 4 weeks before baseline, with no planned changes during the acute intervention phase except as clinically necessary * Sufficient proficiency in English or another IRB-approved language to understand study procedures and provide informed consent, with approved translated materials or interpreter support when available * If of reproductive potential, agrees to applicable pregnancy-prevention requirements during the acute intervention phase * Willing to follow study lifestyle and safety requirements, including restrictions on alcohol and substance use before study sessions and applicable post-session safety recommendations Exclusion Criteria: * History of seizure disorder or other condition that, in the investigator's judgment, would make exposure to stroboscopic or patterned light stimulation unsafe * Severe photosensitivity or light sensitivity that could be worsened by exposure to flashing or patterned light * Implanted electronic or other medical device that is incompatible with study neuromodulation procedures * Unstable or clinically significant cardiovascular, neurologic, or other medical condition that could make study participation unsafe * Unstable or high-risk psychiatric condition, including: * Recent suicide attempt or current imminent suicide risk * Active psychosis * Uncontrolled mania or other acute psychiatric instability requiring a higher level of care * Pregnant or breastfeeding at screening or during participation * Acute intoxication or inability/unwillingness to comply with study safety restrictions regarding alcohol or non-prescribed/recreational substance use before study sessions * Unstable or rapidly changing psychotropic medication regimen at baseline * Concurrent participation in another interventional trial targeting behavioral health or neuromodulation that, in the investigator's judgment, would confound study outcomes or create a safety concern * Any other medical, psychiatric, cognitive, or behavioral condition that, in the investigator's judgment, would prevent safe participation or meaningful completion of study procedures

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Tactical Mind Research Coalition

    Tampa, Florida, 33618, United States

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