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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in scores on the 17-item Hamilton Rating Scale for Depression (HRSD-17)

Secondary study objectives

Change in scores on the Beck Scale for Suicide Ideation (BSI)

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.

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