Treatment for depression in individuals with spinal cord injuries

Treatment of Depression Post-SCI: Retrospective Analysis and Feasibility Trial

This study is testing if a new treatment called rTMS can help people with spinal cord injuries who are also dealing with depression feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 14 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Medical University of South Carolina (Academic / other)
• Locations: 1 site (Charleston, South Carolina)
• Trial ID: NCT04263285 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and effectiveness of repetitive transcranial magnetic stimulation (rTMS) as a treatment for depression in individuals who have experienced spinal cord injuries (SCI). Fourteen participants with cervical or thoracic level SCI and diagnosed major depressive disorder will undergo rTMS treatment five days a week for four weeks. The study aims to assess changes in depressive symptoms and the overall safety of the rTMS method. If successful, the findings could pave the way for larger studies to improve treatment options for this population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 who are at least six months post-injury and have partial movement of the right thumb.

Not a fit: Patients with concomitant neurological disorders, cognitive impairments, or a history of major head trauma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the mental health and quality of life for individuals suffering from depression following spinal cord injuries.

How similar studies have performed: While the use of rTMS for depression is established, its application specifically for individuals with spinal cord injuries is novel and has not been extensively tested.

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.

Where this trial is running

Charleston, South Carolina

• Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Catherine VanDerwerker, DPT, PhD — Medical University of South Carolina
• Study coordinator: Catherine VanDerwerker, DPT, PhD

Conditions Depression; Spinal Cord Injuries