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Brain Stimulation

rTMS for Depression in Autism (rTMS-MDD Trial)

N/A
Recruiting
Led By Stephanie H Ameis, MD, MSC
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, end of weeks 1, 2, 3, 4, 5, and 6 of treatment, and at 1-week, 4-weeks and 12-weeks post-treatment.
Awards & highlights

rTMS-MDD Trial Summary

This trial is testing whether a brain stimulation treatment called rTMS can help improve symptoms of depression in people with autism. The motivation for the trial is that depression is common and often disabling in people with autism, and there are no current trials testing any treatment for depression in autism. A previous pilot study suggested that rTMS may be a feasible and well-tolerated treatment for depression in people with autism.

Who is the study for?
This trial is for young adults with autism who are also dealing with depression. They should be fluent in English, able to consent, clinically stable without medication changes for a month, and have an IQ of 70 or above. Those who are actively suicidal, pregnant, have seizures history or recent substance abuse can't participate.Check my eligibility
What is being tested?
The study tests rTMS (a type of brain stimulation) to see if it helps improve depression symptoms in autistic youth. Participants will receive either the real rTMS treatment or a sham (fake) version to compare outcomes in a controlled setting.See study design
What are the potential side effects?
rTMS may cause mild to moderate side effects like discomfort at the stimulation site, headache, lightheadedness or seizures very rarely. It's generally well tolerated by participants.

rTMS-MDD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, end of weeks 1, 2, 3, 4, 5, and 6 of treatment, and at 1-week, 4-weeks and 12-weeks post-treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, end of weeks 1, 2, 3, 4, 5, and 6 of treatment, and at 1-week, 4-weeks and 12-weeks post-treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in scores on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
Secondary outcome measures
Change in scores on the Beck Scale for Suicide Ideation (BSI)

rTMS-MDD Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active bilateral theta burst stimulationActive Control1 Intervention
An X100 stimulator with a B65 A/P type coil (Magventure Inc.) will be used. The coil is positioned under MRI guidance using real-time neuronavigation using Brainsight [x,y,z= -38, 44, 26(left), +38, 44, 26 (right). BL-TBS will be delivered at 90% RMT, corrected for scalp to cortex distance, to targeted left and right DLPFC sites, differing only in stimulation pattern and total number of pulses (triplet 50 Hz bursts, repeated at 200 msec (i.e., 5 Hz); right DLPFC (continuous TBS, cTBS): 120 seconds uninterrupted bursts (total of 600 pulses); left DLPFC (intermittent TBS, iTBS: 2 seconds on and 8 seconds off; 600 pulses per session; total duration of 3 min 9 seconds/hemisphere).
Group II: Sham bilateral theta burst stimulationPlacebo Group1 Intervention
An X100 stimulator with a B65 A/P type coil (Magventure Inc.) will be used with the active coil facing away from the scalp, for sham stimulation. The coil is positioned under MRI guidance using real-time neuronavigation using Brainsight [x,y,z= -38, 44, 26(left), +38, 44, 26 (right). To reproduce the nociceptive qualities of the stimulation, the B65-type stimulation coil - sham side - includes a built in electrical stimulator in the coil connector which "fires" a synchronous electrical pulse along with the TMS stimulus through electrodes mounted on the forehead or near the area of stimulation, to generate auditory and somatosensory (vibration) stimuli.

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
354 Previous Clinical Trials
81,040 Total Patients Enrolled
84 Trials studying Depression
19,047 Patients Enrolled for Depression
Stephanie H Ameis, MD, MSCPrincipal InvestigatorCentre for Addiction and Mental Health

Media Library

Active Bilateral Theta Burst Stimulation (Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04972136 — N/A
Depression Research Study Groups: Sham bilateral theta burst stimulation, Active bilateral theta burst stimulation
Depression Clinical Trial 2023: Active Bilateral Theta Burst Stimulation Highlights & Side Effects. Trial Name: NCT04972136 — N/A
Active Bilateral Theta Burst Stimulation (Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04972136 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project accepting participants aged 30 and above?

"As indicated by the inclusion criteria, this study is recruiting patients between 16 and 29 years of age. Additionally, there are 583 trials for individuals under 18 and 1491 studies open to participants over the age of 65."

Answered by AI

Are participants able to join the clinical trial at this juncture?

"As shown on clinicaltrials.gov, this study is actively recruiting participants and was last updated on July 12th 2021. The trial originally began accepting applications in January 14th 2021."

Answered by AI

How many individuals have been recruited to partake in this investigation?

"Affirmative. According to records hosted on clinicaltrials.gov, this medical research is actively enrolling participants as of July 12th 2021; the study was first publicly posted in mid-January of this year and requires 80 volunteers from a single site."

Answered by AI

Could I be a suitable candidate to join this investigation?

"This trial is enrolling 80 adolescents and young adults with autism spectrum disorder between 16-29 years old. Applicants must demonstrate stability through a physician's judgement, preserve an unchanging regimen of psychotropic medications for 30 days prior to application, score at least 21 on the Beck Depression Inventory II (BDI-II) over two weeks leading up to enrollment, or receive below adequate functioning scores on the Vineland Adaptive Behavior Scales III (VABS-III)."

Answered by AI

Who else is applying?

What site did they apply to?
Centre for Addiction and Mental Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
rTMS for Depression in Young Adults With Autism
Stephanie Ameis 2021. "rTMS for Depression in Young Adults With Autism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04972136.
All > Asd > Autism
~36 spots leftby Jan 2027
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