Recruiting

rTMS

Sponsor:

VA Office of Research and Development

Code:

NCT05553353

Conditions

Spinal Cord Injuries

Depression

Depressive Disorder, Major

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

repetitive transcranial magnetic stimulation--Active

repetitive transcranial magnetic stimulation--Sham

Study Details

Brief summary:

Depression is a leading cause of disability worldwide and is more commonly seen in individual's post-spinal cord injury (SCI) than in the general population. Depression post-SCI impacts an individuals' quality of life and recovery. It has been reported that among Veterans with an SCI, those without depression live longer than those with depression. Thus, depression must be treated appropriately. Repetitive transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression, but dosing is based on a motor response or movement in the thumb. Over half of individuals with SCI have some degree of arm or hand impairment, so these individuals might not be eligible for rTMS, or they may receive the wrong dose. This study proposes clinical trial in individuals with depression post-SCI to assess the anti-depressant effect of a novel technique to dose rTMS that does not require a motor response in the thumb. By gaining a better understanding of the application of rTMS for depression post-SCI, the investigators aim to advance the rehabilitative care of Veterans.

Conditions

Spinal Cord Injuries

Depression

Depressive Disorder, Major

Study ID

NCT05553353

Start date

Mar 31, 2025

Status verified date

Jan, 2026

Completion date

Oct 29, 2027

Anticipated

Primary completion date

Apr 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • cervical or thoracic spinal cord injury at least 6 months prior with AIS A, B, C, or D;
  • 18 - 60 years of age;
  • major depressive disorder, as identified by Structured Clinical Interview for DSM-V;
  • Hamilton Depression Rating Scale-17 score > 18;
  • not taking antidepressant medications or no change in doses of psychotropic medication(s) for at least 4 weeks before the study (6 weeks if newly initiated medication)

Exclusion Criteria:

  • concomitant neurologic diseases/disorders or dementia;
  • cognitive impairment (Montreal Cognitive Assessment <17);
  • history of psychosis or other Axis I disorder that is primary;
  • positive screen for bipolar disorder through the Mini-International Neuropsychiatric Interview;
  • history of claustrophobia;
  • life expectancy <1 year;
  • electronic or metallic implants (i.e., metal in the head, cochlear implant, or pacemaker;
  • history of seizures or currently prescribed anti-seizure medications;
  • taking medication that increases the risk of seizures;
  • pregnancy as identified through a positive urine pregnancy test;
  • Hamilton Depression Rating Scale-17 question #3 regarding suicide: >2 or suicide attempt within the previous two years;
  • inability to (University of California, San Diego Brief Assessment of Capacity to Consent) or declined to give informed consent.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active rTMS

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.

sham comparator: Sham rTMS

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.

Interventions

repetitive transcranial magnetic stimulation--Active

Repetitive transcranial magnetic stimulation (rTMS) is a type of non-invasive brain stimulation. An active coil will be used to administer the active rTMS.

repetitive transcranial magnetic stimulation--Sham

Repetitive transcranial magnetic stimulation (rTMS) is a type of non-invasive brain stimulation. A sham coil will be used to administer the sham rTMS.

Primary outcome measure

  • Change from baseline in Hamilton Depression Rating Scale-17 (HAM-D17) score immediately post-intervention [ Time Frame: Baseline; Following Week 2 of 6-week intervention Following Week 4 of 6-week intervention; Immediately post-intervention; 12-weeks post-intervention; 24-weeks post-intervention ]

Central Contacts and Locations

Central contacts

Catherine J VanDerwerker, PhD DPT PT

(843) 792-5047catherine.vanderwerker@va.gov

Sarah A Jackson, BA MA

(843) 789-6700sarah.jackson@va.gov

Locations

Ralph H. Johnson VA Medical Center, Charleston, SC

Recruiting

Charleston, South Carolina, United States, 29401-5703

Contacts

Catherine J VanDerwerker, PhD DPT PT

843-792-5047catherine.vanderwerker@va.gov

Sarah A Jackson, BA MA

(843) 789-6700sarah.jackson@va.gov

Principal Investigator:

Catherine J VanDerwerker, PhD DPT PT

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Keywords

  • Spinal Cord Injuries
  • Depression
  • Depressive Disorder, Major
  • Transcranial Magnetic Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-01-14.