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NCT04263285 | RECRUITING | Depression

Treatment of Depression Post-SCI
Sponsor:

Medical University of South Carolina

Information provided by (Responsible Party):

Catherine VanDerwerker

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.

Condition or disease

Depression

Spinal Cord Injuries

Intervention/treatment

rTMS

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 14 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Treatment of Depression Post-SCI: Retrospective Analysis and Feasibility Trial
Actual Study Start Date : 2026-02
Estimated Primary Completion Date : 2029-09
Estimated Study Completion Date : 2029-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Treatment of Depression Post-SCI

Location Details

NCT04263285

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Locations

RECRUITING

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425