Cincinnati, Ohio 45229

  • Major Depressive Disorder

Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Have been diagnosed on the autism spectrum - Have been diagnosed with depression and have failed one or more evidence-based antidepressant treatments (e.g. a Selective Serotonin Reuptake Inhibitor, talk therapy like Cognitive Behavioral Therapy) - Do not have an intellectual disability Exclusion Criteria: - Substance use disorder - Presence of metallic foreign bodies or implanted medical devices - History of epilepsy - Prior rTMS treatment - For female subjects of child bearing potential, current pregnancy


NCT ID:

NCT05271357


Primary Contact:

Principal Investigator
Ernest Pedapati, MD
Children's Hospital Medical Center, Cincinnati

Elizabeth J Blank
Phone: 513-803-8635
Email: Elizabeth.blank@cchmc.org


Backup Contact:

Email: Grace.westerkamp@cchmc.org
Grace Westerkamp


Location Contact:

Cincinnati, Ohio 45229
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 28, 2022

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