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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, post-treatment point of 1 month
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am not pregnant.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Depression severity (change in score)
Secondary outcome measures
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
933 Previous Clinical Trials
7,394,515 Total Patients Enrolled
40 Trials studying Depression
6,853 Patients Enrolled for Depression
National Alliance for Research on Schizophrenia & DepressionUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of seizures or a seizure disorder.I am on a stable dose of medication that doesn't lower seizure risk or act as an antidepressant.I am not pregnant.My brain or spinal cord disease is getting worse.I do not have schizophrenia, severe bipolar disorder, or dementia.You are currently taking part in or planning to join another study for therapy treatment.I do not have any unstable heart, kidney, lung, stomach, or hormonal diseases.I have had a moderate or severe brain injury.I can speak English, fill out forms, follow treatment plans, and attend regular visits.
Research Study Groups:
This trial has the following groups:- Group 1: Dose 9
- Group 2: Dose 10
- Group 3: Study 2: 10 Active Doses
- Group 4: Dose 2
- Group 5: Dose 3
- Group 6: Dose 4
- Group 7: Dose 5
- Group 8: Dose 6
- Group 9: Dose 7
- Group 10: Dose 8
- Group 11: Dose 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible to join this clinical trial?
"The requirements to be considered for this trial are a diagnosis of depression and an age between 18 and 60. The researchers hope to gather approximately 100 participants before the study's closure."
Answered by AI
Are volunteers still being accepted for this investigation?
"Indeed, current clinicaltrials.gov records reveal that recruitment for this trial is ongoing since its posting on May 25th 2021 and subsequent editing in November 11th 2022. The study seeks 100 volunteers from a single center."
Answered by AI
How many people can participate in this clinical research at maximum capacity?
"Correct. Clinicaltrials.gov indicates that this clinical study, which began on May 25th 2021 is presently recruiting patients to fill its 100 person quota from 1 location."
Answered by AI
Does this study encompass individuals of all ages, or are there restrictions?
"This clinical trial is recruiting individuals aged 18 to 60."
Answered by AI
Who else is applying?
What site did they apply to?
Medical University of South Carolina
What portion of applicants met pre-screening criteria?
Met criteria
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