Recruiting

rTMS

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT04972136

Conditions

Autism Spectrum Disorder

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 16 - 35

Healthy Volunteers: Not accepted

Interventions

Active Bilateral Theta Burst Stimulation

Sham Bilateral Theta Burst Stimulation

Study Details

Brief summary:

The current clinical trial is focused on evaluating the efficacy of rTMS for treatment of depression in youth and young adults (hereafter called transition aged youth, TAY) with autism spectrum disorder (ASD). The motivation to undertake the current efficacy study is driven by: (1) the substantial impact of depression on TAY with ASD (based on prevalence and contribution to disability/impairment); (2) lack of evidence-based treatments for depression in autism (there are no current trials rigorously evaluating any treatment for depression, i.e., psychotherapeutic, pharmacotherapeutic, brain stimulation); (3) rTMS has demonstrated efficacy in non-autistic individuals to improve symptoms of depression and may be better tolerated in youth than medication treatment; (4) a prior pilot rTMS study focused on treatment of executive function deficits in autism indicated that high frequency rTMS delivered using a rigorous randomized control trial (RCT) protocol can be feasibly implemented in TAY with autism, is well tolerated (mild to moderate adverse effects and low drop out), and has the potential to improve symptoms of depression.

Conditions

Autism Spectrum Disorder

Major Depressive Disorder

Study ID

NCT04972136

Start date

Jan 14, 2021

Status verified date

Mar, 2026

Completion date

Jan 14, 2027

Anticipated

Primary completion date

Jan 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 35

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active 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).

sham comparator: Sham bilateral theta burst stimulation

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.

Interventions

Active Bilateral Theta Burst Stimulation

A total of 30 active BL-TBS sessions. Stimulation will begin with right DLPFC (cTBS) followed by left DLPFC (iTBS)

Sham Bilateral Theta Burst Stimulation

A total of 30 sham BL-TBS sessions. Stimulation will begin with right DLPFC (cTBS) followed by left DLPFC (iTBS)

Primary outcome measure

  • Change in scores on the 17-item Hamilton Rating Scale for Depression (HRSD-17) [ Time Frame: Baseline, end of weeks 1, 2, 3, 4, 5, and 6 of treatment, and at 1-week, 4-weeks and 12-weeks post-treatment. ]

Central Contacts and Locations

Central contacts

Viviane Grassmann, PhD

416-535-8501AutismTMS@camh.ca

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M6J 1H4

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

  • Autism Spectrum Disorder
  • Major Depressive Disorder
  • rTMS (Repetitive Transcranial Magnetic Stimulation)
  • MRI (Magnetic Resonance Imaging)
  • Suicidal and Self-Injurious Behaviour
  • Adaptive Functioning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2026-03-19.