rTMS treatment for depression in adults with autism
Feasibility and Efficacy of rTMS in Depression in Individuals With Autism Spectrum Disorder (ASD)
This trial will try repetitive transcranial magnetic stimulation (rTMS) and intermittent theta-burst stimulation (iTBS) to see if they reduce major depressive episodes in adults with autism spectrum disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hospital Center Guillaume Régnier Academic / other |
| Locations | 1 site (Rennes) |
| Trial ID | NCT07258914 on ClinicalTrials.gov |
What this trial studies
Adults with a confirmed diagnosis of autism spectrum disorder and a current major depressive episode will receive a course of noninvasive brain stimulation using either standard rTMS or intermittent theta-burst stimulation. Treatments are delivered at a hospital rTMS clinic over multiple sessions, with clinicians monitoring side effects and depressive symptoms. Key eligibility includes age 18–65, a MADRS score >20, stable treatment for at least one month, and no contraindications to rTMS or MRI. The trial will track changes in depression ratings and feasibility/tolerability outcomes before, during, and after the stimulation course.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–65 with a psychiatrist-confirmed autism diagnosis, a current major depressive episode (MADRS >20), stable treatments for at least one month, and no contraindications to rTMS/MRI who can give informed consent.
Not a fit: Patients with certain psychiatric comorbidities (like active mania or psychosis), pregnancy, a history of epilepsy, implanted electronic or metallic devices that contraindicate rTMS/MRI, or those unable to attend repeated clinic sessions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could reduce depressive symptoms in adults with ASD and offer an alternative to medications that are often less effective or poorly tolerated in this population.
How similar studies have performed: Previous small open-label studies (fewer than 20 patients) have reported encouraging pre–post improvements using left dorsolateral prefrontal cortex stimulation and theta-burst protocols, but evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with a diagnosis of ASD validated by a psychiatrist or line 2 * Patient aged 18 to 65... * Patients suffering from EDM (MADRS greater than 20) * No change in treatment in the month prior to inclusion * Patients affiliated with or entitled to social security * Patients who have received informed information about the study and have signed a consent form to participate in the study Exclusion Criteria: * Patients with psychiatric comorbidity (decompensated manic state, schizophrenic disorder) * Pregnancy at the time of inclusion * Patients with contraindications to rTMS and MRI (history of epilepsy, neurological stimulator, pacemaker, cardiac defibrillator, cardiac prosthesis, vascular prosthesis, intracranial clips or clamps, cerebrospinal fluid shunt, metal fragments in the eyes, claustrophobia) * Adults under legal protection (legal guardianship, curatorship, trusteeship), persons deprived of their liberty, persons hospitalised under compulsion (SDT, SDRE).
Where this trial is running
Rennes
- Centre Hospitalier Guillaume Régnier — Rennes, France (Recruiting)
Study contacts
- Principal investigator: Cécilia NAUCZYCIEL, Doctor — Centre Hospitalier Guillaume Régnier
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.