rTMS for Depression in Young Adults With Autism

NCT04972136 | Recruiting

• 1 other identifier: 141/2019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  The investigators will evaluate the changes in the severity of symptoms of depression before, during, and after rTMS treatment. HRSD-17 scores range from 0 to 52, with higher scores indicating greater severity of depressive symptoms (worse outcome).

  Baseline, end of weeks 1, 2, 3, 4, 5, and 6 of treatment, and at 1-week, 4-weeks and 12-weeks post-treatment.

Secondary Outcomes (1)

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

  Baseline, end of weeks 1, 2, 3, 4, 5, and 6 of treatment, and at 1-week, 4-weeks and 12-weeks post-treatment.

Study Arms (2)

Active bilateral theta burst stimulation

ACTIVE COMPARATOR

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).

Device: Active Bilateral Theta Burst Stimulation

Sham bilateral theta burst stimulation

SHAM COMPARATOR

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.

Device: Sham Bilateral Theta Burst Stimulation

Interventions

Active Bilateral Theta Burst Stimulation DEVICE

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

Also known as: X100 with a B65-type coil (Magventure Inc.)

Active bilateral theta burst stimulation

Sham Bilateral Theta Burst Stimulation DEVICE

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

Also known as: X100 with a B65-type coil (Magventure Inc.)

Sham bilateral theta burst stimulation

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Depressive Disorder, Major; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Depressive Disorder; Mood Disorders; Behavioral Symptoms; Behavior

Study Officials

• Stephanie H Ameis, MD, MSC

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Viviane Grassmann, PhD

CONTACT

416-535-8501; AutismTMS@camh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: July 22, 2021
• Study Start: January 14, 2021
• Primary Completion (Estimated): January 14, 2027
• Study Completion (Estimated): January 14, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)