NCT05271357

Transcranial Magnetic Stimulation for Depression in Autism Spectrum Conditions

Theta Burst Stimulation for Refractory Depression in Autism Spectrum Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 12 Years – 26 Years
• Healthy volunteers: Not accepted

Summary

In this research study the investigators aim to learn more about the therapeutic effects of a newer form of non-invasive transcranial magnetic stimulation (TMS), called theta burst simulation (TBS), on refractory depression in Autism Spectrum Conditions.

Detailed description

The overarching goal of this study is to examine treatment effects and elucidate the physiological biomarkers of a newer form of non-invasive brain stimulation therapy on refractory depression in a sample of participants with ASC (autism spectrum condition). Aim 1: To compare the efficacy of 30-sessions of bilateral (BL) versus unilateral (UL) Theta Burst Stimulation to the dorsolateral prefrontal cortex (DLPFC) on depression severity in youth/young adults with ASC and co-occurring refractory major depressive disorder (MDD). Aim 2: To identify physiological markers of target engagement of successful response to either UL or BL on depression severity in youth with ASC and co-occurring refractory MDD. These physiological markers include high-resolution electroencephalography (EEG) markers, social eye-tracking, and handgrip strength (collected via NIH toolbox's motor toolbox domain). Aim 3: To identify feasibility of BL and UL in participants with ASC including systematic measures of safety and tolerability. This includes clinical measures such as rate of hospitalization and medication use.

Conditions

• Autism Spectrum Disorder
• Major Depressive Disorder

Interventions

Type	Name	Description
PROCEDURE	Bilateral TMS	Stimulation begins with continuous TBS to the right dorsolateral prefrontal cortex (DLPFC) (120 seconds of uninterrupted bursts; 600 pulses per session) followed by intermittent TBS to the left DLPFC (2 seconds on and 8 seconds off; 600 pulses per session); total duration of 3 min 9 seconds per hemisphere.
PROCEDURE	Unilateral TMS	Stimulation involves only intermittent TBS to the left DLPFC (2 seconds on and 8 seconds off; 600 pulses per session); total duration of 3 min 9 seconds.

Timeline

• Start date: 2021-11-24
• Primary completion: 2023-02-23
• Completion: 2023-02-23
• First posted: 2022-03-09
• Last updated: 2024-02-07

Locations

1 site across 1 country: United States