Transcranial Magnetic Stimulation for Depression in Autism Spectrum Conditions

NCT05271357 | Completed DMC

• 1 other identifier: 2021-0594
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Major Depressive Disorder

Keywords

Transcranial magnetic stimulation; TMS; MDD; ASD; TBS; theta burst stimulation; autism; depression

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Change-from-baseline at 4 weeks in physiological markers via the use of high-resolution electroencephalography (EEG).

  4 weeks post-treatment

• Change-from-baseline at 4 weeks in handgrip strength or relative handgrip strength.

  4 weeks post-treatment

Study Arms (2)

Bilateral

EXPERIMENTAL

Theta burst stimulation (TBS)

Procedure: Bilateral TMS

Unilateral

ACTIVE COMPARATOR

Theta burst stimulation (TBS)

Procedure: Unilateral TMS

Interventions

Bilateral TMS PROCEDURE

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.

Bilateral

Unilateral TMS PROCEDURE

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.

Unilateral

Eligibility Criteria

• Age: 12 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Ernest Pedapati, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: March 9, 2022
• Study Start: November 24, 2021
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

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

Locations

US (1)