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Brain Stimulation

Repetitive Transcranial Magnetic Stimulation (rTMS) for Depression (rTMS Trial)

Phase 1
Waitlist Available
Led By Lisa M. McTeague, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks post-treatment
Awards & highlights

rTMS Trial Summary

This trial is testing a new brain stimulation treatment to help veterans with multiple mental disorders. The treatment is designed to improve problem solving and adaptive cognition.

Eligible Conditions
  • Depression
  • Mental Health
  • Repetitive Transcranial Magnetic Stimulation
  • Psychosocial Disability
  • Post-Traumatic Stress Disorder
  • Anxiety

rTMS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Illness Intrusiveness Rating Scale (IIRS)
Inventory of Psychosocial Functioning (IPF)
World Health Organization Quality of Life - Brief Form (WHOQOL-BF)
Secondary outcome measures
Hamilton Scale for Depression (HAM-D)
Inventory of Depression and Anxious Symptoms (IDAS-II)
Mood and Anxiety Symptom Questionnaire (MASQ)
+1 more

rTMS Trial Design

10Treatment groups
Experimental Treatment
Group I: 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 1 is forty-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.
Group II: 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 1 is forty 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 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 1 is thirty-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.
Group IV: 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 1 is thirty 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 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 1 is twenty-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.
Group VI: 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 1 is twenty 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 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 1 is fifteen 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 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 ten 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 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 1 is fifty 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 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

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,605 Previous Clinical Trials
3,305,575 Total Patients Enrolled
76 Trials studying Depression
20,577 Patients Enrolled for Depression
Lisa M. McTeague, PhDPrincipal InvestigatorRalph H. Johnson VA Medical Center, Charleston, SC
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Repetitive Transcranial Magnetic Stimulation (rTMS) (Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03749967 — Phase 1
Depression Research Study Groups: Dose 10, Dose 7, Dose 2, Dose 6, Dose 8, Dose 1, Dose 9, Dose 5, Dose 3, Dose 4
Depression Clinical Trial 2023: Repetitive Transcranial Magnetic Stimulation (rTMS) Highlights & Side Effects. Trial Name: NCT03749967 — Phase 1
Repetitive Transcranial Magnetic Stimulation (rTMS) (Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03749967 — Phase 1
Depression Patient Testimony for trial: Trial Name: NCT03749967 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are accepted for this medical research initiative?

"Affirmative. Clinicaltrials.gov indicates that this clinical exploration, which was initially advertised on February 1st 2019, is actively looking for volunteers. There is a need to enlist 50 patients from one particular site."

Answered by AI

What is the criteria for enrollment in this trial?

"This trial is searching for 50 people aged 18-60 who suffer from depression. To be eligible, applicants must meet this criteria."

Answered by AI

Is enrollment for this trial still open to the public?

"Per the clinicaltrials.gov website, this research is still in progress and actively seeking participants. The initial posting date was February 1st 2019 with a most recent update occurring on September 15th 2022."

Answered by AI

Is Repetitive Transcranial Magnetic Stimulation (rTMS) sanctioned by the FDA?

"Our team at Power rated the safety of Repetitive Transcranial magnetic stimulation (rTMS) as a 1 since this is a Phase 1 trial. Thus, there are only preliminary findings that suggest its efficacy and protection from hazards."

Answered by AI

Is the age threshold for this research limited to 30 years or above?

"The eligibility criteria for this medical trial requires that potential participants are aged between 18 and 60 years. Those younger than 18 have access to 261 trials, while those older than 65 can choose from 1,226 other studies."

Answered by AI

What is the primary objective of this research endeavor?

"This trial's primary endpoint is to accurately assess patients' psychosocial functioning over a 4-week period. Secondary endpoints include the Mood and Anxiety Symptom Questionnaire (MASQ), which uses a five point Likert scale ranging from "not at all" to "extremely", the Inventory of Depression and Anxious Symptoms (IDAS-II) with responses scored between 1 and 5, and the Hamilton Scale for Depression (HAM-D). This latter assessment entails eight items rated on a 0 - 4 scale while nine are ranked from 0 - 2. Results can range in severity from mild to severe."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
What site did they apply to?
Ralph H. Johnson VA Medical Center, Charleston, SC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have chronic depression ptsd anxiety add with suicidal ideation.
PatientReceived 1 prior treatment
~3 spots leftby Mar 2025