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rTMS Dosing for Depression Post-Spinal Cord Injury
N/A
Waitlist Available
Led By Catherine J VanDerwerker, PhD DPT PT
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 baseline; following week 2 of 6-week intervention following week 4 of 6-week intervention; 12-weeks post-intervention; 24-weeks post-intervention
Awards & highlights
Study Summary
This trial is testing a new way to give a common depression treatment to people who can't use the standard method.
Who is the study for?
This trial is for adults aged 18-60 with major depressive disorder and a spinal cord injury (cervical or thoracic) of at least 6 months duration. Candidates should not be on antidepressants, or have stable doses for at least 4 weeks. They must not have cognitive impairments, psychosis, metallic implants, seizure history, pregnancy, high suicide risk, other neurological disorders/dementia or claustrophobia.Check my eligibility
What is being tested?
The study tests a new way to dose repetitive transcranial magnetic stimulation (rTMS), an FDA-approved depression treatment that doesn't rely on thumb movement responses—important for those with arm/hand impairment post-spinal cord injury. It compares active rTMS against sham (placebo-like) treatment to assess its effect on depression in these individuals.See study design
What are the potential side effects?
Common side effects of rTMS include discomfort at the stimulation site during treatment sessions, headache after treatments and rarely seizures may occur. Some patients might experience lightheadedness or tingling sensations as well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline; following week 2 of 6-week intervention following week 4 of 6-week intervention; 12-weeks post-intervention; 24-weeks post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; following week 2 of 6-week intervention following week 4 of 6-week intervention; 12-weeks post-intervention; 24-weeks post-intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mental Depression
Secondary outcome measures
Mental Depression
Change from baseline in Craig Handicap Assessment and Reporting Tool - Short Form (CHART-SF) Score at timepoints noted below
Spinal Cord
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active rTMSExperimental Treatment1 Intervention
Active repetitive transcranial magnetic stimulation (rTMS) that will be administered 5 days/week for 6 weeks. Intensity will be individualized based on reverse-calculation electric-field modeling.
Group II: Sham rTMSPlacebo Group1 Intervention
Sham repetitive transcranial magnetic stimulation (rTMS) that will be administered 5 days/week for 6 weeks. Intensity will be individualized based on reverse-calculation electric-field modeling, but a sham treatment coil will be used; thus, no active treatment will be administered.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,579 Total Patients Enrolled
76 Trials studying Depression
20,665 Patients Enrolled for Depression
Catherine J VanDerwerker, PhD DPT PTPrincipal InvestigatorRalph H. Johnson VA Medical Center, Charleston, SC
Catherine VanDerwerker, PT DPT PhDPrincipal InvestigatorRalph H. Johnson VA Medical Center, Charleston, SC
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a neurological condition or dementia.I have a history of seizures or am on seizure medication.I am on medication that could increase my risk of seizures.I have been diagnosed with major depressive disorder.I am able to understand and agree to participate in the study.I haven't changed my mental health medication doses for at least 4 weeks.I had a spinal cord injury in my neck or upper back over 6 months ago.I am between 18 and 60 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Active rTMS
- Group 2: Sham rTMS
Awards:
This trial has 0 awards, including: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 there still opportunities to become involved in this experiment?
"The clinicaltrials.gov database does not currently list this trial as actively recruiting patients. The original posting of the study was on October 2nd 2023, and it has been edited for the last time on September 20th 2022. However, there are 1,639 other medical trials that remain open to potential participants at this time."
Answered by AI
Are individuals under the age of 55 allowed to participate in this scientific investigation?
"Candidates must be between 18 and 60 years old to qualify for this trial."
Answered by AI
Who fulfills the eligibility criteria for this trial?
"This medical study stipulates that the only eligible patients are those aged 18-60 with spinal cord injuries. A maximum of 24 participants will be admitted to this trial."
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