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Non-invasive Brain Stimulation

Theta Burst Stimulation for Treatment-Resistant Depression (ciTBS Trial)

N/A
Recruiting
Led By Yvette Sheline, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 - 70 years of age
Failed 2+ prior treatments (treatment-refractory)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will use a new TMS protocol to see if it is more effective than current TMS protocols in treating patients with treatment-resistant depression.

Who is the study for?
This trial is for adults aged 18-70 with major depressive disorder who haven't improved after at least two treatments. They must score ≥20 on a depression scale, speak English, and can consent to treatment. Exclusions include MRI contraindications, implanted medical devices like pacemakers, pregnancy, recent substance abuse issues, or certain neurological conditions.
What is being tested?
The study tests an accelerated form of magnetic brain stimulation called intermittent Theta Burst Stimulation (iTBS), concentrating the usual 6-week protocol into five days for those with treatment-resistant depression.
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases. The rapid pace of this specific protocol's side effects are not fully known but will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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My condition did not improve after two or more treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Depressive Symptoms Change
Secondary study objectives
Self report Symptom Change

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Compressed iTBS scheduleExperimental Treatment1 Intervention
Stimulation 3-pulse 50-Hz bursts at 5-Hz for 2-s trains, with trains every 10 s, for 10 minutes, 10 times a day, for 5 consecutive days.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,066 Previous Clinical Trials
42,712,869 Total Patients Enrolled
Yvette Sheline, MDPrincipal Investigator - University of Pennsylvania
Penn Behavoral Health, University Of Penn-Outpatient Psychiatry Center
Boston University School Of Medicine (Medical School)
Beth Israel Deaconess Hp M C (Residency)
1 Previous Clinical Trials
34 Total Patients Enrolled

Media Library

Intermittent Theta Burst Stimulation (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04684706 — N/A
Major Depressive Disorder Research Study Groups: Compressed iTBS schedule
Major Depressive Disorder Clinical Trial 2023: Intermittent Theta Burst Stimulation Highlights & Side Effects. Trial Name: NCT04684706 — N/A
Intermittent Theta Burst Stimulation (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04684706 — N/A
~4 spots leftby May 2025
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