Treatment of Depression Post-SCI

NCT ID: NCT04263285

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2029-09-30

Brief Summary

Depression is more common after a spinal cord injury (SCI) than in the general population. Unfortunately, it is unknown how depression is typically treated in individuals with SCI or if commonly used treatment methods are effective. This study will investigate the safety and impact of a novel method for treating depression called repetitive transcranial magnetic stimulation (rTMS). rTMS is a type of non-invasive brain stimulation. Fourteen individuals with a cervical or thoracic level SCI and depression will complete an approved treatment plan using rTMS. Participants will be treated using rTMS five days a week for four weeks. After four weeks of treatment, the study team will review the safety of rTMS and assess changes in depressive symptoms. If the results are positive, larger studies can be designed to develop better treatment options for individuals with SCI and depression.

Conditions

Depression; Spinal Cord Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rTMS (Repetitive Transcranial Magnetic Stimulation)

Group Type: EXPERIMENTAL

rTMS

Intervention Type: DEVICE

The study team will deliver rTMS five days a week for four weeks, according to a specific and approved protocol for participant positioning, motor threshold determination, and dosing.

Interventions

rTMS

The study team will deliver rTMS five days a week for four weeks, according to a specific and approved protocol for participant positioning, motor threshold determination, and dosing.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age 18 - 70;

2. At least 6 months post incomplete cervical or incomplete or complete thoracic level SCI;

3. Have at least partial active movement of the right thumb (abductor pollicis brevis) to allow for FDA approved rTMS dosing;

4. Major depressive disorder, as identified through screening tools;

5. No antidepressant medications or no change in doses of psychotropic medication(s) for at least 4 weeks prior to the study (6 weeks if newly initiated medication).

Exclusion Criteria

1. Concomitant neurologic diseases/disorders or dementia;

2. Cognitive impairment, as identified through a screening tool (Montreal Cognitive Assessment);

3. History of major head trauma as identified through a screening tool (Ohio State University Traumatic Brain Injury Identification Method);

4. History of psychosis or other Axis I disorder that is primary;

5. Positive screen for bipolar disorder, as identified through a screening tool (The Mood Disorder Questionnaire);

6. Life expectancy <1 year;

7. Attempt of suicide in the last 2 years;

8. Electronic or metallic implants (i.e. metal in the head, cochlear implant, or pacemaker);

9. History of seizures or currently prescribed anti-seizure medications;

10. Taking medication that increases the risk of seizures;

11. Pregnancy as identified through a positive pregnancy test;

12. Inability or unwillingness of subject or legal guardian/representative to give informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Craig H. Neilsen Foundation

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Catherine VanDerwerker

Research Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine VanDerwerker, DPT, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Catherine VanDerwerker, DPT, PhD

Role: CONTACT

vanderwe@musc.edu

843-792-5047

Facility Contacts

Catherine VanDerwerker, DPT, PhD

Role: primary

Other Identifiers

00086228

Identifier Type: -

Identifier Source: org_study_id