ClinicalTrials.Veeva

Menu

Transcranial Magnetic Stimulation for Depression in Autism Spectrum Conditions (RESTORE)

Cincinnati Children's Hospital Medical Center logo

Cincinnati Children's Hospital Medical Center

Status

Completed

Conditions

Major Depressive Disorder
Autism Spectrum Disorder

Treatments

Procedure: Bilateral TMS
Procedure: Unilateral TMS

Study type

Interventional

Funder types

Other

Identifiers

NCT05271357
2021-0594

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

12 to 26 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

17 participants in 2 patient groups

Bilateral
Experimental group
Description:
Theta burst stimulation (TBS)
Treatment:
Procedure: Bilateral TMS
Unilateral
Active Comparator group
Description:
Theta burst stimulation (TBS)
Treatment:
Procedure: Unilateral TMS

Trial documents
1

Trial contacts and locations

1

Loading...

Central trial contact

Grace Westerkamp; Elizabeth J Blank

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems