Treatment of Depression Post-SCI

NCT04263285 | Recruiting

• 1 other identifier: 00086228
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Safety as assessed by number of adverse events

  Report of adverse and serious adverse events in all participants.

  Through the study period (5 weeks)

• Number of visits missed

  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

  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 Outcomes (7)

• Change in depressive symptoms as assessed by the Montgomery- Asberg Depression Rating Scale (MADRS)

  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.

  Baseline, midpoint (Week 3), and post treatment (5 weeks)

• Change in subjective well-being based on the Satisfaction With Life Scale.

  Baseline and post treatment (5 weeks)

• Change in physical activity based on the Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury

  Baseline and post treatment (5 weeks)

• Change in function as assessed by the Spinal Cord Independence Measure III-Self Report.

  Baseline and post treatment (5 weeks)

Study Arms (1)

rTMS (Repetitive Transcranial Magnetic Stimulation)

EXPERIMENTAL

Device: rTMS

Interventions

rTMS 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.

rTMS (Repetitive Transcranial Magnetic Stimulation)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 70;
• At least 6 months post incomplete cervical or incomplete or complete thoracic level SCI;
• Have at least partial active movement of the right thumb (abductor pollicis brevis) to allow for FDA approved rTMS dosing;
• Major depressive disorder, as identified through screening tools;
• 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).

You may not qualify if:

• Concomitant neurologic diseases/disorders or dementia;
• Cognitive impairment, as identified through a screening tool (Montreal Cognitive Assessment);
• History of major head trauma as identified through a screening tool (Ohio State University Traumatic Brain Injury Identification Method);
• History of psychosis or other Axis I disorder that is primary;
• Positive screen for bipolar disorder, as identified through a screening tool (The Mood Disorder Questionnaire);
• Life expectancy \<1 year;
• Attempt of suicide in the last 2 years;
• Electronic or metallic implants (i.e. metal in the head, cochlear implant, or pacemaker);
• History of seizures or currently prescribed anti-seizure medications;
• Taking medication that increases the risk of seizures;
• Pregnancy as identified through a positive pregnancy test;
• Inability or unwillingness of subject or legal guardian/representative to give informed consent.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Depression; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Catherine VanDerwerker, DPT, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine VanDerwerker, DPT, PhD

CONTACT

843-792-5047; vanderwe@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 10, 2020
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)