Treatment of Depression Post-SCI

March 2, 2026 updated by: Catherine VanDerwerker, Medical University of South Carolina

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Catherine VanDerwerker, DPT, PhD
  • Phone Number: 843-792-5047
  • Email: vanderwe@musc.edu

Study Locations

    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
          • Catherine VanDerwerker, DPT, PhD

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rTMS (Repetitive Transcranial Magnetic Stimulation)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety as assessed by number of adverse events
Time Frame: Through the study period (5 weeks)
Report of adverse and serious adverse events in all participants.
Through the study period (5 weeks)
Number of visits missed
Time Frame: Throughout the treatment period (4 weeks)
The average of the number of intervention visits missed across all participants
Throughout the treatment period (4 weeks)
Change in depressive symptoms as assessed by the Hamilton Rating Scale for Depression
Time Frame: Baseline, midpoint (Week 3), and post treatment (5 weeks)
The Hamilton Rating Scale for Depression consists of 17 questions with a total score range from 0 - 52. Ranges of total score include the following: 0 - 7 suggests normal/no depressive symptoms; 8 - 16 suggests mild depressive symptoms; 17 - 23 suggests moderate depressive symptoms; and 24 - 52 suggests severe depressive symptoms.
Baseline, midpoint (Week 3), and post treatment (5 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depressive symptoms as assessed by the Montgomery- Asberg Depression Rating Scale (MADRS)
Time Frame: Baseline, midpoint (Week 3), and post treatment (5 weeks)

Montgomery- Asberg Depression Rating Scale consists of 10 questions with a range of 0 - 60.

Ranges of total score include the following: 0 - 6 suggest normal/ no depressive symptoms; 7 - 19 suggests mild depressive symptoms; 20 - 34 suggests moderate depressive symptoms; and 34 - 60 suggests severe depressive symptoms.

Baseline, midpoint (Week 3), and post treatment (5 weeks)
Change in the impact depressive symptoms have on one's life as assessed by the Sheehan Disability Scale.
Time Frame: Baseline, midpoint (Week 3), and post treatment (5 weeks)
The Sheehan Disability Scale is a self-report questionnaire that assess how depressive symptoms have impacted one's ability to participate in work/school, social life, and family life. Each question is scored from 0 (not at all) to 10 (extremely). Total score ranges from 0 (unimpaired) to 30 (highly impaired).
Baseline, midpoint (Week 3), and post treatment (5 weeks)
Change in subjective well-being based on the Satisfaction With Life Scale.
Time Frame: Baseline and post treatment (5 weeks)
The Satisfaction With Life Scale is a self-report questionnaire regarding subjective well-being. The scale consists of 5 questions that are rated between 1 (Strongly Disagree) to 7 (Strongly Agree). Pre and post intervention answers will be compared.
Baseline and post treatment (5 weeks)
Change in physical activity based on the Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury
Time Frame: Baseline and post treatment (5 weeks)
Self-report questionnaire regarding the number of days and minutes an individual participates in mild, moderate, and heavy intensity physical activity/effort. Pre and post intervention answers will be compared.
Baseline and post treatment (5 weeks)
Change in function as assessed by the Spinal Cord Independence Measure III-Self Report.
Time Frame: Baseline and post treatment (5 weeks)
The Spinal Cord Independence Measure III-Self Report is a self-report questionnaire regarding the degree of assistance needed for daily self care activities, such as eating, bathing, dressing, grooming, breathing, bladder and bowel management, toileting, transfers, and mobility. There are a total of 17 questions with a total score of 0 (assistance required) to 100 (no assistance or mobility aids). Pre and post intervention scores will be compared.
Baseline and post treatment (5 weeks)
Change in function and daily activities as assessed by the Craig Handicap Assessment and Reporting Tool-Short Form
Time Frame: Baseline and post treatment (5 weeks)
The Craig Handicap Assessment and Reporting Tool-Short Form is a self-report questionnaire that includes a total of 19 questions regarding physical assistance, cognitive assistance, mobility, occupation, social integration, and financial resources. Pre and post intervention answers will be compared.
Baseline and post treatment (5 weeks)
Change depressive symptoms as assessed by the Patient Health Questionnaire-9 score
Time Frame: Baseline, midpoint (Week 3), and post treatment (5 weeks)
The Patient Health Questionnaire-9 is a 9 questions self-report measure of depressive symptoms. The total score ranges from 0 - 27. Ranges of total score include the following: 0 suggests no depressive symptoms; 1 - 4 suggests minimal depressive symptoms; 5 - 9 suggests mild depressive symptoms; 10 - 14 suggests moderate depressive symptoms;15 - 19 suggests moderately severe depressive symptoms; and 20 - 27 suggests severe depressive symptoms.
Baseline, midpoint (Week 3), and post treatment (5 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Catherine VanDerwerker, DPT, PhD, 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 Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

February 4, 2020

First Submitted That Met QC Criteria

February 6, 2020

First Posted (Actual)

February 10, 2020

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 00086228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on rTMS

Search Similar Trials