Transcranial Magnetic Stimulation for Depression in Autism Spectrum Conditions

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder; Major Depressive Disorder
• Interventions: Procedure: Unilateral TMS; Procedure: Bilateral TMS

• Registration Number: NCT05271357
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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.

Study Timeline

• Study First Submitted: 2021-10-28
• Study Start: 2021-11-24
• Study First Submitted QC: 2022-03-04
• Study First Posted: 2022-03-09
• Primary Completion: 2023-02-23
• Study Completion: 2023-02-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unilateral	Unilateral TMS	Theta burst stimulation (TBS)
Bilateral	Bilateral TMS	Theta burst stimulation (TBS)

Primary Outcome Measures

Name	Time	Method
Change-from-baseline at 4 weeks in mean Hamilton Depression Rating Scale (HDRS-17) score.	4 weeks post-treatment	The HDRS-17 is a valid and reliable measure that assesses severity of, and change in, depressive symptoms. HDRS-17 scores range from 0-52, with scores of 0-7 indicating absence or remission of depression, 7-17 indicating mild depression, 18-24 indicating moderate depression, and scores at or over 25 indicating severe depression.
Change-from-baseline at 4 weeks in mean and Beck Depression Inventory (BDI-II) scores.	4 weeks post-treatment	The BDI-II is a valid and reliable measure for assessing the severity of depressive symptoms. BDI-II scores range from 0-63, with scores of 0-10 indicating absence or remission of depression, 11-16 indicating mild mood disturbance, 17-20 indicating borderline clinical depression, 21-30 indicating moderate depression, 31-40 severe depression, and scores over 40 indicating extreme depression.

Secondary Outcome Measures

Name	Time	Method
Change-from-baseline at 4 weeks in handgrip strength or relative handgrip strength.	4 weeks post-treatment	Handgrip strength is particularly novel and has been shown to be negatively associated with depressive symptoms, making muscle strength a possible clinical marker of poor mental health. The grip strength test from NIH Toolbox's motor domain will be used to collect a digital reading of force in pounds from each participant.
Change-from-baseline at 4 weeks in physiological markers via the use of high-resolution electroencephalography (EEG).	4 weeks post-treatment	EEG offers a real-time image of cortical excitability and connectivity. We will use power spectral analysis to assess changes in event-related gamma and alpha activity.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States