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Non-invasive Brain Stimulation

Bilateral TMS for Autism Spectrum Disorder (RESTORE Trial)

N/A
Waitlist Available
Led By Ernest Pedapati, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks post-treatment
Awards & highlights

RESTORE Trial Summary

This trial will study whether theta burst stimulation can help ease depression in people with autism spectrum conditions.

Eligible Conditions
  • Autism Spectrum Disorder
  • Autism
  • Depression

RESTORE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change-from-baseline at 4 weeks in mean Hamilton Depression Rating Scale (HDRS-17) score.
Change-from-baseline at 4 weeks in mean and Beck Depression Inventory (BDI-II) scores.
Secondary outcome measures
Change-from-baseline at 4 weeks in handgrip strength or relative handgrip strength.
Change-from-baseline at 4 weeks in physiological markers via the use of high-resolution electroencephalography (EEG).

RESTORE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BilateralExperimental Treatment1 Intervention
Theta burst stimulation (TBS)
Group II: UnilateralActive Control1 Intervention
Theta burst stimulation (TBS)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bilateral TMS
2021
N/A
~20

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,579 Total Patients Enrolled
23 Trials studying Autism Spectrum Disorder
10,517 Patients Enrolled for Autism Spectrum Disorder
Ernest Pedapati, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
2 Previous Clinical Trials
55 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
40 Patients Enrolled for Autism Spectrum Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate figure for participants enrolled in this experiment?

"Affirmative. Clinicaltrials.gov registers that this medical trial, which was posted on November 24th 2021, is actively recruiting individuals. The research requires the enrollment of approximately 24 people at one healthcare facility."

Answered by AI

Is it still possible to participate in the trial?

"According to clinicaltrials.gov, the recruitment process for this medical trial is currently ongoing - it was first posted on November 24th 2021 and updated as recently as April 1st 2022."

Answered by AI

Are there any age restrictions when it comes to enrolling in this clinical trial?

"This trial is specifically seeking out patients aged between 12 and 26. For comparison, there are 583 trials for minors and 1491 studies for seniors."

Answered by AI

Am I qualified to take part in this research?

"To join this autism-related clinical trial, 24 participants aged 12 to 26 must be identified. The requisite characteristics are a diagnosis on the autism spectrum, an absence of intellectual disability, and evidence of depression not assuaged through established treatments (such as SSRIs or CBT)."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
New York
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Cincinnati Children's Hospital Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Transcranial Magnetic Stimulation for Depression in Autism Spectrum Conditions
Ernest Pedapati, MD 2021. "Transcranial Magnetic Stimulation for Depression in Autism Spectrum Conditions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05271357.
~5 spots leftby Apr 2025
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