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Non-invasive Brain Stimulation

High-Dose rTMS for Depression

N/A
Recruiting
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A negative urine pregnancy test, if female subject of childbearing potential
Be between 18 and 65 years old
Must not have
History of seizures or a seizure disorder.
CNS disease deemed progressive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, post-treatment point of 1 month
Awards & highlights

Summary

This trial is testing a new, accelerated protocol of rTMS to see if it's more effective than the conventional protocol.

Who is the study for?
This trial is for individuals with depression who can speak English, consent to the study, and commit to regular visits. Pregnant women must have a negative pregnancy test. People with progressive CNS diseases, recent drug abuse (except nicotine/caffeine), or unstable medical conditions are excluded.
What is being tested?
The trial tests an accelerated protocol of repetitive Transcranial Magnetic Stimulation (rTMS) called intermittent theta burst (iTBS). It aims to establish a dose-response curve for iTBS on depressive symptoms and explore individual variations in response based on functional networks.
What are the potential side effects?
While rTMS is generally safe, potential side effects may include discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases. The risk of seizures is higher if certain medications are taken.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of seizures or a seizure disorder.
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My brain or spinal cord disease is getting worse.
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I do not have any unstable heart, kidney, lung, stomach, or hormonal diseases.
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I have had a moderate or severe brain injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, post-treatment point of 1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, post-treatment point of 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Depression severity (change in score)
Secondary study objectives
Comorbidity

Trial Design

11Treatment groups
Experimental Treatment
Group I: Study 2: 10 Active DosesExperimental Treatment1 Intervention
All participants will be assigned to 10 sessions (per treatment day) of accelerated rTMS for 5 treatment days. All doses are active and within established therapeutic levels of rTMS. Dose 10 is 50 active sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Group II: Dose 9Experimental Treatment1 Intervention
All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 9 is 40 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Group III: Dose 8Experimental Treatment1 Intervention
All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 8 is 35 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Group IV: Dose 7Experimental Treatment1 Intervention
All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 7 is 30 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Group V: Dose 6Experimental Treatment1 Intervention
All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 6 is 25 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Group VI: Dose 5Experimental Treatment1 Intervention
All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 5 is 20 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Group VII: Dose 4Experimental Treatment1 Intervention
All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 4 is 20 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Group VIII: Dose 3Experimental Treatment1 Intervention
All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 3 is 15 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Group IX: Dose 2Experimental Treatment1 Intervention
All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 2 is 10 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Group X: Dose 10Experimental Treatment1 Intervention
All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 10 is 40 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Group XI: Dose 1Experimental Treatment1 Intervention
All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is five sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive Transcranial Magnetic Stimulation (rTMS)
2019
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
960 Previous Clinical Trials
7,399,460 Total Patients Enrolled
42 Trials studying Depression
7,234 Patients Enrolled for Depression
National Alliance for Research on Schizophrenia & DepressionUNKNOWN

Media Library

Brief, High-dose rTMS (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04657432 — N/A
Depression Research Study Groups: Dose 9, Dose 10, Study 2: 10 Active Doses, Dose 2, Dose 3, Dose 4, Dose 5, Dose 6, Dose 7, Dose 8, Dose 1
Depression Clinical Trial 2023: Brief, High-dose rTMS Highlights & Side Effects. Trial Name: NCT04657432 — N/A
Brief, High-dose rTMS (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04657432 — N/A
~24 spots leftby Sep 2025
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