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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, post-treatment point of 1 month

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met