Dosing rTMS for Depression Post-SCI

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
VA Office of Research and Development
Study ID
NCT05553353
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 31, 2025
Status verified
Jan 2026
Primary completion
Apr 15, 2027
Completion
Oct 29, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Ralph H. Johnson VA Medical Center, Charleston, SCCharlestonSouth Carolina29401-5703
Catherine J VanDerwerker, PhD DPT PT
[email protected]
843-792-5047
Sarah A Jackson, BA MA
[email protected]
(843) 789-6700
Catherine J VanDerwerker, PhD DPT PT (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charleston, SC

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Ralph H. Johnson VA Medical Center, Charleston, SC· Charleston, SC

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