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Could a headset prevent suicide? small study tests home brain stimulation

NCT ID NCT05280756

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether a home-based brain stimulation device (tDCS) could help prevent suicidal thoughts in adults recently discharged from the hospital for mood disorders. Thirty-three participants used the headset for 30 minutes a day over two weeks, supervised remotely. The main goal was to see if people could stick with the treatment at home, not yet to prove it works.

What this could mean

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

Active substance
transcranial direct current stimulation (tDCS) device
What this could lead to
If it works, this could offer a safe, home-based option to reduce suicide risk after a hospital stay.
What could go wrong
This is a very small feasibility study (33 participants) testing only whether people can use the device at home, not whether it truly prevents suicidal thoughts. Results may not apply broadly.

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

33 people

The number who actually took part.

Started

Sep 2023

Finished

Jun 2024

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 65 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 between 18 and 65 years * diagnosis of mood or bipolar disorder registered in the electronic hospital medical record * history of suicidal ideation and/or suicidal behavior at the time of admission registered in the electronic hospital medical record * absent of suicidal ideation at the time of enrollment (defined as questions 1 and 2 of the C-SSRS answered "no") * ability and willingness to provide information and permission to contact at least one person in the case of a need to contact them to promote subject safety or inability to reach the subject for follow-up * a living situation with access to a private space suitable for the administration of the RS-tDCS sessions in the next three weeks * agree to use a medically acceptable form of birth control while receiving the treatment if you are an individual able to become pregnant * living in Monroe County region, as this is the area covered by the Mobile Crisis Team, a URMC psychiatric emergency team serving anyone within Monroe County * device or computer with internet access for a URMC-approved remote RS-tDCS supervision * ability to manage proper use of the device in a practice session Exclusion Criteria: * acute psychiatric instability or substance abuse (e.g., psychotic symptoms, alcohol misuse in the previous three months, use of any illicit drugs in the previous three months) * unstable medical condition with reduction of functional capacity * history of epilepsy or seizures in the last year * history of neurodegenerative diseases registered in the electronic hospital medical record * presence of or implanted any ferromagnetic metal in the head or the neck * pregnant or breastfeeding or willingness to become pregnant in the next month * history of head trauma (e.g., head injury, brain injury) or neurosurgery * history of skin disorder or sensitive skin area near stimulation locations * the presence of pacemaker * current treatment with electroconvulsive therapy or transcranial magnetic stimulation

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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

  • University of Rochester

    Rochester, New York, 14642, United States

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