rTMS for Depression in Young Adults With Autism (rTMS-MDD)
Autism Spectrum Disorder, Major Depressive Disorder
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Major Depressive Disorder, rTMS (Repetitive Transcranial Magnetic Stimulation), MRI (Magnetic Resonance Imaging), Suicidal and Self-Injurious Behaviour, Adaptive Functioning
Eligibility Criteria
Inclusion Criteria:
- Fluent in English
- ASD diagnosis confirmed by the clinician/clinical team, and IQ> or =70
- Able to participate in the informed consent process, provide voluntary informed consent and provide a spontaneous narrative description of the key elements of the study
- Clinical stability: determined by a physician, no switch of psychotropic medications or increase in dosage in the last 30 days; no change in other therapeutic interventions in last 30 days
- BDI-II score ≥21 that is sustained over a lead-in period of two weeks
- Global Assessment of Function (GAF) scores (≤60) that is sustained over a lead-in period of two weeks AND/OR VABS-III below adequate functioning at baseline assessment.
Exclusion Criteria:
- A history of a DSM-5 substance use disorder (other than tobacco) within the past six months; or a positive baseline urine drug screen
- Significantly debilitating medical or neurologic illness, or acute or unstable medical illnesses as determined by study physician
- Metal implants or a pace-maker, claustrophobia that would preclude the MRI scan
- Actively suicidal (i.e., suicidal ideation with plan and intent) or high risk for suicide as assessed by a study psychiatrist
- History of seizures
- Taking benzodiazepines at a dose greater or equal to 2mg Lorazepam or any anticonvulsant medication
- Prior rTMS treatment
- Pregnancy
Sites / Locations
- Centre for Addiction and Mental HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Active bilateral theta burst stimulation
Sham bilateral theta burst stimulation
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).
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.