Using Transcranial Magnetic Stimulation to Treat Depression in Autism
Neuromodulation for Depression in Autism Spectrum Disorder
NA · Yale University · NCT06142955
This study is trying out a new brain treatment to see if it can help people with autism who also have depression feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Yale University (other) |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06142955 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of intermittent Theta Burst Stimulation (iTBS) using Transcranial Magnetic Stimulation (TMS) on individuals with Autism Spectrum Disorder (ASD) who also experience depression. Participants will undergo two sessions, one week apart, where they will receive either active TMS or sham stimulation, with assessments of cognitive and behavioral functions, as well as neural responses through EEG and eye-tracking. The study aims to provide preliminary insights into the efficacy of TMS as a treatment for depression in this population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 40 with a diagnosis of Autism Spectrum Disorder and a depression score of at least 20 on the HDRS-17.
Not a fit: Patients with significant head trauma, serious brain illnesses, or major psychiatric disorders that interfere with study measures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a novel treatment option for managing depression in individuals with Autism Spectrum Disorder.
How similar studies have performed: While TMS has been explored in various contexts, this specific application for treating depression in Autism Spectrum Disorder is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals from Yale University and the surrounding community who are between the ages of 18 and 40 years old with or without a diagnosis of depression. Or individuals between the ages of 18 and 40 years old with a diagnosis of autism spectrum disorder, autistic disorder, PDD NOS, or Asperger syndrome with or without a diagnosis of depression. * A depression score on the HDRS-17 of at least 20 will be used as a cut-off for depression. * Participants are unmedicated or on stable medication treatment for at least two weeks. * Willingness and ability to participate in an EEG and eye-tracking procedure. * Provision of signed and dated informed consent. Exclusion Criteria: * Participants reporting significant head trauma or serious brain illness. * Participants unable to provide signed informed consent. * Participants with major psychiatric illness that would preclude completion of study measures. Participants with diagnosis of a psychotic or bipolar illness with be excluded. * Participants with a history of serious medical illness, stroke, seizures, epileptiform EEG abnormalities, or family history of epilepsy. * Participants taking prescription medications that may affect cognitive processes under study. * Participants taking any medication that may increase their risk of seizures. * Participants who have taken alcohol or recreational drugs within the preceding 24 hours prior to the scheduled study visit as determined by the urine toxicology test. * Participants with a history of substance or alcohol abuse or dependence in the past 6 months. * Participants with a significant risk of suicide or a h/o suicide attempt in the last 6 months. Participants with active suicidal ideation will be excluded from the study. * Females of known/suspected pregnancy or who test positive on a pregnancy test. * Participants with a history of metalworking or injury by shrapnel or metallic objects. * Participants with a history of prior TMS therapy or use of an investigational drug within 12 weeks of visit * Participants with an IQ below 80 (as confirmed by the WASI, Wechsler Abbreviated Scale of Intelligence)
Where this trial is running
New Haven, Connecticut
- Yale Psychiatric Hospital — New Haven, Connecticut, United States (RECRUITING)
Study contacts
- Principal investigator: Sherab Tsheringla, MD — Yale University
- Study coordinator: Sherab Tsheringla, MD
- Email: sherab.tsheringla@yale.edu
- Phone: 2032158046
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.
Conditions: Autism Spectrum Disorder