Transcranial Magnetic Stimulation for Depression in Autism Spectrum Conditions

Major Depressive Disorder Clinical Trial

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Official title:

Theta Burst Stimulation for Refractory Depression in Autism Spectrum Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05271357
• Other study ID #: 2021-0594
• Status: Completed
• Phase: N/A
• Start date: November 24, 2021
• Est. completion date: February 23, 2023

Study information

• Verified date: February 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 23, 2023
• Est. primary completion date: February 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change-from-baseline at 4 weeks in mean Hamilton Depression Rating Scale (HDRS-17) score.	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.	4 weeks post-treatment
Primary	Change-from-baseline at 4 weeks in mean and Beck Depression Inventory (BDI-II) scores.	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.	4 weeks post-treatment
Secondary	Change-from-baseline at 4 weeks in physiological markers via the use of high-resolution electroencephalography (EEG).	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.	4 weeks post-treatment
Secondary	Change-from-baseline at 4 weeks in handgrip strength or relative handgrip strength.	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.	4 weeks post-treatment