Dosing rTMS for Depression Post-SCI

NCT05553353 | Recruiting FDA Device

• 2 other identifiers: D3972-W1IK2RX003972-01A1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Hamilton Depression Rating Scale-17 (HAM-D17) score immediately post-intervention

  The Hamilton Rating Scale for Depression (HAM-D17) is the most widely used tool to assess the severity of depressive symptoms, once diagnosed, and will be used in this study. The HAM-D17 is a semi-structured interview style questionnaire that asks about one's experience with seventeen different depressive symptoms over the past week. Total HAM-D17 scores range from no depressive symptoms (HAM-D17 = 0-7); mild (HAM-D17 = 8-16), moderate (HAM-D17 = 17-23) or severe depressive symptoms (HAMD-D17 = 24).

  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

Secondary Outcomes (6)

• Change from baseline in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) at timepoints noted below

  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

• Change from baseline in Sheehan Disability Scale (SDS) Score at timepoints noted below

  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

• Change from baseline in Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI) Score at timepoints noted below

  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

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

  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

• Change from baseline in Reintegration to Normal Living Index (RNL) Score at timepoints noted below

  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

Study Arms (2)

Active rTMS

EXPERIMENTAL

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.

Device: repetitive transcranial magnetic stimulation--Active

Sham rTMS

SHAM COMPARATOR

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.

Device: repetitive transcranial magnetic stimulation--Sham

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.

Also known as: rTMS

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.

Also known as: rTMS

Sham rTMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• cervical or thoracic spinal cord injury at least 6 months prior with AIS A, B, C, or D;
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Catherine J VanDerwerker, PhD DPT PT

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine J VanDerwerker, PhD DPT PT

CONTACT

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

Sarah A Jackson, BA MA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * Participants will be blinded to group (active vs. sham) assignments. * The assessor performing the resting motor threshold (rMT) testing will be blinded to any pre-determined electric-field modeling values or group assignments. * Staff member applying the rTMS treatment will be blinded, and an unblinded study staff member will set up the appropriate coil (active vs. sham) prior to each treatment session. * The staff member completing outcome assessments will be blinded to participant group assignments. * During the immediate post-testing session, the staff members applying the rTMS treatments and those completing the outcome assessments, as well as each participant, will be asked if they think active or sham treatment was received. This will allow for post-hoc assessment on blinding. * Unblinding will only occur in the case of a medical emergency or after all follow-up testing has been completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will: 1. undergo high-resolution T1- and T2-weighted MRI scanning. These images will be used for image guided TMS assessments and e-field calculations for rTMS intensity. 2. undergo rTMS to the left dorsolateral prefrontal cortex (DLPFC) as a treatment approach for depression. Treatment (active or sham) will be performed five times/week for six weeks (30 sessions). A total of 3,000 pulses/session will be delivered at 10Hz (4 seconds on and 26 seconds off) for a total of 75 stimulation cycles that lasts 37.5 minutes. The intensity will be individualized, as it will be based on reverse-calculation electric-field modeling. Participants receiving sham stimulation will undergo the same procedures as active rTMS except that a coil specifically designed to provide sham stimulation that is double-blinded will be utilized.

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 23, 2022
• Study Start: March 31, 2025
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): October 29, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)