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TMS for Depression
Phase 2 & 3
Waitlist Available
Led By Mark S George, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the 4th week of treatment (or 6 weeks in those who continue to 6 weeks).
Awards & highlights
Study Summary
This trial is testing whether timing brain stimulation pulses with the person's natural brain rhythms will make the treatment more effective.
Eligible Conditions
- Depression
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the 4th week of treatment (or 6 weeks in those who continue to 6 weeks).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the 4th week of treatment (or 6 weeks in those who continue to 6 weeks).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Remission Rate
Secondary outcome measures
EEG phase synchronization
EEG-TMS-fMRI Bold changes in cingulate cortex
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SYNC TMSExperimental Treatment1 Intervention
Patients will receive daily left prefrontal transcranial magnetic stimulation (TMS), 120% MT, 3000 pulses/session, for 30 sessions. They will have EEG and the TMS will be delivered at their individual alpha frequency (IAF) (8-12 Hz) and the first TMS pulse in each train of 40 pulses will be synchronized with the EEG so that the TMS pulse fires during the rising phase of the alpha rhythm.
Group II: Non-Sync TMSActive Control1 Intervention
Patients will receive daily left prefrontal transcranial Magnetic stimulation (TMS), 120% MT, 3000 pulses/session, for 30 sessions. They will have EEG and the TMS will be delivered at their individual alpha frequency (IAF) (8-12 Hz) and the first TMS pulse in each train of 40 pulses will NOT be synchronized with the EEG so that the TMS pulse fires during the rising phase of the alpha rhythm. This is the way conventional TMS is delivered now and is FDA approved.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Magnetic Stimulation (TMS)
2018
Completed Phase 4
~570
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,785 Previous Clinical Trials
2,689,722 Total Patients Enrolled
666 Trials studying Depression
251,550 Patients Enrolled for Depression
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,601 Total Patients Enrolled
40 Trials studying Depression
6,919 Patients Enrolled for Depression
Mark S George, MDPrincipal InvestigatorMedical University of South Carolina
4 Previous Clinical Trials
173 Total Patients Enrolled
1 Trials studying Depression
48 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a pretreatment score of at least 20.You have tried different antidepressant medications, but they haven't worked well enough for you. You have been feeling this way for less than 3 years.You are not currently using Vagus Nerve Stimulation.You cannot have a history of seizures or neurological disorders, brain surgery, or head trauma with loss of consciousness for more than 15 minutes. You also cannot have an implanted electronic device, metal in your head, or be pregnant.You do not currently have thoughts of hurting yourself or a recent history of trying to harm yourself.You have been diagnosed with major depressive disorder, but you do not have any hallucinations or delusions.You do not have a history of mental health conditions such as schizophrenia, bipolar disorder, or dementia. You also have not had substance abuse issues (except for nicotine) in the past year, and you are not currently experiencing symptoms of certain disorders such as delirium or post-traumatic stress disorder.
Research Study Groups:
This trial has the following groups:- Group 1: SYNC TMS
- Group 2: Non-Sync TMS
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.
Are geriatric patients welcome in this clinical trial?
"The age requirements for this study are that participants must be over 21 but under 70 years old."
Answered by AI
Are there currently any open slots for patients in this trial?
"The clinical trial referenced is not currently looking for participants, however this may change in the future. This particular study was posted on 11/30/2018 and last edited on 2/8/2022. There are plenty of other opportunities available, as 1350 trials are actively recruiting patients."
Answered by AI
Are there any restrictions for participants in this trial?
"This study is looking for 34 participants with depression between the ages of 21 and 70 who have responded inadequately to 1-4 prior antidepressant medication trials or shown intolerance to at least 3 different medications. Additionally, applicants must meet the following criteria: No contraindication to rTMS (history of neurological disorder or seizure (except induced by ECT), increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for >15 minutes, implanted electronic device, metal in the head, or pregnancy), No current Vagus Nerve Stimulation, No history of failing to respond to an adequate course of ECT in"
Answered by AI
Who else is applying?
What state do they live in?
South Carolina
How old are they?
18 - 65
What site did they apply to?
Medical University of South Carolina Brain Stimulation Division
What portion of applicants met pre-screening criteria?
Met criteria
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