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Theta Burst Stimulation for Depression and Autism (RETSORE-RCT Trial)

N/A

Recruiting

Led By Rana Elmaghraby, 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

Aged 13-26, inclusive

Symptoms of moderate to severe depression according to Hamilton Depression Rating Scale ≥ 20 which must be maintained through lead-in period

Must not have

Prior rTMS treatment

Contraindications to Transcranial Magnetic Stimulation including, but not limited to, a history of epilepsy, the presence of metallic foreign bodies, or implanted medical devices (e.g. pacemaker, medical pump)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up completed at baseline, 2-week, 6-week, and 12-week follow up

Summary

This trial will test if a treatment called accelerated theta burst stimulation can help reduce depressive symptoms in people with autism.

Who is the study for?

This trial is for individuals with Autism Spectrum Disorder (ASD) who are also experiencing hard-to-treat depression. Participants should be diagnosed with both conditions and have not found relief from standard treatments.

What is being tested?

The study is testing the effectiveness of a technique called accelerated theta burst stimulation (aTBS), which uses magnetic fields to stimulate certain areas of the brain, in reducing symptoms of depression in people with ASD.

What are the potential side effects?

Possible side effects may include discomfort at the site of stimulation, headache, lightheadedness, or seizures; however, these are generally rare and will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 13 and 26 years old.

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I have moderate to severe depression.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously undergone rTMS treatment.

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I do not have epilepsy, metallic implants, or a pacemaker.

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I am currently taking medication for seizures, mood, or anxiety.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ completed at baseline, 2-week, 6-week, and 12-week follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~completed at baseline, 2-week, 6-week, and 12-week follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and completed at baseline, 2-week, 6-week, and 12-week follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

17-item Hamilton Rating Scale for Depression (HDRS)

NIH Toolbox Cognition Battery

Secondary study objectives

Electroencephalography (EEG)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active TBS TreatmentActive Control1 Intervention

Active aTBS targeting the left dorsolateral prefrontal cortex, 5 sessions per day for 5 days.

Group II: Sham controlledPlacebo Group1 Intervention

Sham aTBS targeting the left dorsolateral prefrontal cortex, 5 sessions per day for 5 days. If participants in the sham group do not show a significant treatment response by the 12-week follow-up - defined as a 50% reduction from baseline on the HDRS- they will then become eligible for and offered active, open-label treatment.

0 / 5Eligibility criteria met