Brain zaps tailored to you: new hope for stubborn depression?
NCT ID NCT05144789
First seen Jun 26, 2026 · Last updated Jul 30, 2026 · Updated 3 times
Summary
This study tested a personalized brain stimulation technique called accelerated intermittent theta burst stimulation (aiTBS) in 79 people with treatment-resistant depression. The goal was to see if targeting specific brain areas could ease symptoms like loss of pleasure (anhedonia). Participants received either active stimulation or a sham procedure, and their depression levels were measured before and after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- accelerated intermittent theta burst stimulation (aiTBS) using a transcranial magnetic stimulation device
- What this could lead to
- If successful, this could point toward a new, personalized brain stimulation treatment for people with hard-to-treat depression who don't respond to standard therapies.
- What could go wrong
- This is a small, early-stage study with only 79 participants. The results may not apply to everyone with depression, and the effects might not last long-term.
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
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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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70 people
The number who actually took part.
- Started
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May 2022
- Finished
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Dec 2025
- 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 80 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. Male or Female, between the ages of 18 and 80 at the time of screening. 2. Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments and aiTBS interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information. 3. Currently diagnosed with Major Depressive Disorder (MDD)and meets criteria for a Major Depressive Episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5). 4. The patient has demonstrated a failure of one or more trials of a pharmacological medication as treatment for MDD. 5. MADRS score of ≥20 at screening (Visit 1). 6. TMS naive. 7. Access to ongoing psychiatric care before and after completion of the study. 8. Must be on a stable antidepressant therapeutic regimen for 6 weeks prior to study enrollment and agree to continue this regimen throughout the study period. 9. In good general health, as evidenced by medical history. 10. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation. 11. Agreement to adhere to Lifestyle Considerations throughout study duration. Exclusion Criteria: 1. Pregnancy 2. History of or current psychotic disorder or bipolar disorder 3. Severe borderline personality disorder 4. Diagnosis of Intellectual Disability or Autism Spectrum Disorder 5. Primary psychiatric condition other than MDD requiring treatment except stable comorbid anxiety disorder 6. Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal 7. Urine screening test positive for illicit substances 8. Acute suicide risk based on clinical judgement or a suicide attempt within the past 6 months 9. Any history of ECT (greater than 8 sessions) without meeting responder criteria 10. Recent (within 4 weeks of any clinical effect) or concurrent use of rapid acting antidepressant agent (i.e., ketamine or a course of ECT) 11. History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma 12. Untreated or insufficiently treated endocrine disorder. 13. Contraindication to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion) 14. Contraindication to MRI (ferromagnetic metal in their body) 15. Treatment with an investigational drug or other intervention within the study period 16. Depth-adjusted aiTBS treatment dose \> 65% maximum stimulator output (MSO) 17. Unstable symptoms between screening and baseline as defined by a ≥ 30% change in MADRS score. 18. Any other condition deemed by the PD to interfere with the study or increase risk to the participant
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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
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Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine
Stanford, California, 94305, United States
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