RECRUITING

Treatment of Depression Post-SCI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-12

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04263285

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	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.

Inclusion Criteria

Exclusion 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).

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.

Contacts and Locations

Study Contact

Catherine VanDerwerker, DPT, PhD

CONTACT

843-792-5047

vanderwe@musc.edu

Principal Investigator

Catherine VanDerwerker, DPT, PhD

PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

Catherine VanDerwerker, DPT, PhD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-12

Study Completion Date2026-09

Study Record Updates

Study Start Date2025-12

Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

Depression
Spinal Cord Injuries