Rewiring reward: brain stimulation aims at a different region for Hard-to-Treat depression

NCT ID NCT05487911

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 13, 2026 · Last updated Oct 13, 2026

Summary

Researchers at Baylor College of Medicine are studying whether repetitive transcranial magnetic stimulation (rTMS) can ease depression when aimed at the orbitofrontal cortex, a brain region involved in reward processing. Standard rTMS targets a different area and helps only some patients. The trial enrolls 50 adults aged 18 to 64 with depressive symptoms, including some with opioid use disorder or suicidal thoughts. Participants receive up to 20 or 25 rTMS sessions over several days or weeks, and researchers measure changes in brain connectivity along with depression, craving, and suicidal behavior.

What this could mean

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

Active substance
repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique
What this could lead to
If it works, targeting the orbitofrontal cortex could offer another option for people whose depression has not responded to standard treatments.
What could go wrong
This is a small study of 50 people, and rTMS to the usual brain target helps only some patients. Stimulating a different region may not improve symptoms, and the approach is still experimental.

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 50 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Aug 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 64 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: 1. Be male or female aged 18-64 years old. 2. Has depressive symptoms according to the PHQ-9 or MADRS or HDRS or SHAPS 3. Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures 4. Female subjects must be non-nursing and not pregnant at the times of fMRI experiments and TMS treatment 5. Has no contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.); Meets the pre-screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI) 6. Has no contraindications to TMS (any types of non-removable metal in their head except the mouth, or within 12 inches of the coil, etc.); Meets the pre-screening TMS safety questionnaire (Transcranial Magnetic Stimulation Adult Safety Screen - TASS) 7. stabilized with medication treatments (e.g., methadone or buprenorphine) or abstinent from opioids if patients are seeking transition to naltrexone 8. urine toxicity test is negative for specific drugs (e.g., opioids) Exclusion Criteria: 1. In the opinion of the clinician and/or the research team, be expected to fail to complete the study protocol due to not tolerable to receive TMS 2. Unable to understand the design and requirements of the study; 3. Unable to sign informed consent for any reason 4. Has an unstable medical condition, including AIDS, acute hepatitis, active TB, unstable cardiac disease, unstable diabetes, hepatic or renal insufficiency 5. Female subjects who are pregnant or nursing 6. Contraindications to MRI (pacemaker, cochlear implants, metal in the eye, other metal implants, etc.): Do not meet the pre-screening MRI questions provided by the CAMRI at BCM 7. Contraindications to TMS (any types of non-removable metal in their head except the mouth, or within 12 inches of the coil, etc.): Do not meet the pre-screening TMS safety questionnaire (TASS). Additional exclusion criteria for the TMS experiments are based on the recommendations described by the international consensus panel on brain stimulation 8. Non-English speaking subjects (we do not have the staff and/or resources to include other languages); 9. Unstable with medication treatments (e.g., methadone or buprenorphine) 10. urine toxicity test is positive for specific drugs (e.g., opioids) 11. currently on seizure medications (e.g., Depakote)

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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.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • The Menninger Clinic

    RECRUITING

    Houston, Texas, 77035, United States

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