Theta Burst Stimulation for Refractory Depression in Autism Spectrum Disorder

NCT06670040 | Active Not Recruiting

• 1 other identifier: 2023-0682
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the efficacy of accelerated theta burst stimulation (aTBS) in reducing depressive symptoms in autism spectrum disorder (ASD)

Conditions

ASD; Autism Spectrum Disorder; Autism; Depression - Major Depressive Disorder; MDD

Keywords

ASD; Autism; Autism Spectrum Disorder; MDD; Depression; TMS; TBS; Transcranial Magnetic Stimulation; Theta Burst Stimulation; Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• 17-item Hamilton Rating Scale for Depression (HDRS)

  The HDRS is a 17-item rating scale administered by a trained rater following a semi-structured interview. Scores of 0-7 are generally within the normal range, and a score of 20 or higher indicates moderate depression severity. Research suggests that a decrement of 7 points on the HAMD-17 represents minimally clinically important differences from patient perspectives. HDRS will be assessed at screening, baseline and all follow up visits.

  Completed at Screening, baseline, 2-week, 6-week, and 12-week follow up

• NIH Toolbox Cognition Battery

  The NIH Toolbox was designed to serve as a brief, convenient set of measures to supplement other outcome measures in epidemiologic and longitudinal research and clinical trials.

  Completed at Screening, 2-week, 6-week, and 12-week follow up

Secondary Outcomes (1)

• Electroencephalography (EEG)

  Completed at baseline, 2-week, 6-week, and 12-week follow up

Study Arms (2)

Sham controlled

SHAM COMPARATOR

Sham aTBS targeting the left dorsolateral prefrontal cortex, 5 sessions per day for 5 days. If participants in the sham group do not show a significant treatment response by the 12-week follow-up - defined as a 50% reduction from baseline on the HDRS- they will then become eligible for and offered active, open-label treatment.

Procedure: Transcranial Magnetic Stimulation Sham

Active TBS Treatment

ACTIVE COMPARATOR

Active aTBS targeting the left dorsolateral prefrontal cortex, 5 sessions per day for 5 days.

Procedure: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation PROCEDURE

All TBS sessions will be delivered at the same site, intensity (up to 90% RMT), pattern and duration. Treatment conditions differ only in the amount of intracranial activation induced (i.e., negligible activation in sham condition). TBS sessions consist of triplet 50 Hz bursts repeated every 200 msec (5 Hz), delivered to the left DLPFC in an intermittent (2 seconds on/8 seconds off) pattern for a total of 600 pulses per session; duration of 3 minutes 9 seconds.

Active TBS Treatment

Transcranial Magnetic Stimulation Sham PROCEDURE

We will use a robust sham technique that suitably replicates the sensory experience (auditory and peripheral activation) of active TBS with minimal intracranial activation. The Magstim Horizon™ sham coil will be utilized for treatment delivery. This sham coil is visually identical to the active coil and replicates the sounds and sensation of the magnetic stimulation. All sham treatment will be delivered at the same site, intensity (up to 90% RMT), pattern and duration. Treatment conditions differ only in the amount of intracranial activation induced (i.e., negligible activation in sham condition). TBS sessions consist of triplet 50 Hz bursts repeated every 200 msec (5 Hz), delivered to the left DLPFC in an intermittent (2 seconds on/8 seconds off) pattern for a total of 600 pulses per session; duration of 3 minutes 9 seconds

Sham controlled

Eligibility Criteria

• Age: 13 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Fluent in English and able to volunteer in the informed consent process and provide spontaneous narrative description of key elements, risks, and benefits of the study.
• Aged 13-26, inclusive.
• Full-scale intelligence quotient ≥ 70.
• Diagnosis of ASD using criteria from Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). Diagnosis will be confirmed by study psychologist/social worker and supported by scoring in the ASD on the Autism Diagnostic Observation Schedule (ADOS-2).
• Diagnosis of MDD based on psychologist diagnosis and DSM-5-based structural diagnostic interview determine via KSADS
• Exhibiting treatment resistance to at least one antidepressant drug treatment of adequate dose and duration.
• Symptoms of moderate to severe depression according to Hamilton Depression Rating Scale ≥ 20 which must be maintained through lead-in period.
• Participants are not required to discontinue current interventions but must agree to attempt to keep medications and other interventions stable during the study.

You may not qualify if:

• Participation in an investigational drug trial within the past three months.
• Active substance use disorder (excluding tobacco use) within the past 6 months.
• Contraindications to Transcranial Magnetic Stimulation including, but not limited to, a history of epilepsy, the presence of metallic foreign bodies, or implanted medical devices (e.g. pacemaker, medical pump).
• Actively suicidal (i.e., suicidal ideation with plan and intent) or deemed at high risk for suicide.
• Current use of anticonvulsant, barbiturate, lithium, or benzodiazepine medications.
• Prior rTMS treatment.
• For female subjects of childbearing potential, a positive urine pregnancy test.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45224, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Depression; Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Rana Elmaghraby, MD

  Cincinnati Childrens Hospital Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: It's a randomized controlled trial with active accelerated Theta Burst Stimulation (aTBS) treatment and sham controlled group

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: November 1, 2024
• Study Start: September 16, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the completion of data collection

Locations

US (1)