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

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; following week 2 of 6-week intervention following week 4 of 6-week intervention; 12-weeks post-intervention; 24-weeks post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mental Depression

Secondary study objectives

Mental Depression

Change from baseline in Craig Handicap Assessment and Reporting Tool - Short Form (CHART-SF) Score at timepoints noted below

Spinal Cord

+3 more

Trial 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.

Do I qualify?Apply below to find out