Rewiring reward: brain stimulation aims at a different region for Hard-to-Treat depression
NCT ID NCT05487911
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 64 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Menninger Clinic
RECRUITINGHouston, Texas, 77035, United States
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