DepressionNCT04263285
Treatment of Depression Post-SCI
A study testing rTMS in people with Depression and Spinal Cord Injuries, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression, Spinal Cord Injuries
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Catherine VanDerwerker, DPT, PhD
About this study
Official title: 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.
- Conditions
- Depression, Spinal Cord Injuries
- Being tested
- rTMS
- Medical subject headings
- Depression, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| rTMS (Repetitive Transcranial Magnetic Stimulation) | Experimental | Not described Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by number of adverse events
Report of adverse and serious adverse events in all participants.
Measured: Through the study period (5 weeks)
Number of visits missed
The average of the number of intervention visits missed across all participants
Measured: 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.
Measured: 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)
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.
Measured: 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.
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).
Measured: Baseline, midpoint (Week 3), and post treatment (5 weeks)
Change in subjective well-being based on the Satisfaction With Life Scale.
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.
Measured: Baseline and post treatment (5 weeks)
Change in physical activity based on the Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury
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.
Measured: Baseline and post treatment (5 weeks)
Change in function as assessed by the Spinal Cord Independence Measure III-Self Report.
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.
Measured: Baseline and post treatment (5 weeks)
Change in function and daily activities as assessed by the Craig Handicap Assessment and Reporting Tool-Short Form
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.
Measured: Baseline and post treatment (5 weeks)
Change depressive symptoms as assessed by the Patient Health Questionnaire-9 score
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.
Measured: Baseline, midpoint (Week 3), and post treatment (5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study startOct 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Catherine VanDerwerker, Medical University of South Carolina
- Investigators
- Catherine VanDerwerker, DPT, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263285
- Sponsor's protocol ID
- 00086228
- Status last verified
- Mar 2026
- First submitted
- 4 Feb 2020
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Depression Post-SCI: Retrospective Analysis and Feasibility Trial
- ClinicalTrials.gov ID
- NCT04263285
- Acronym / sponsor ID
- 00086228
- Conditions
- Depression, Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rTMS (Repetitive Transcranial Magnetic Stimulation) | Experimental | Device: rTMS |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (12 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMSThe 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. | Device | rTMS (Repetitive Transcranial Magnetic Stimulation) |
Primary outcome
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.
Number of visits missed
Time frame: Throughout the treatment period (4 weeks)
The average of the number of intervention visits missed across all participants
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.
7 secondary outcomes
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)
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)
Change in subjective well-being based on the Satisfaction With Life Scale.
Time frame: 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)
Change in function as assessed by the Spinal Cord Independence Measure III-Self Report.
Time frame: 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)
Change depressive symptoms as assessed by the Patient Health Questionnaire-9 score
Time frame: Baseline, midpoint (Week 3), and post treatment (5 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catherine VanDerwerker, DPT, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Depression and Spinal Cord Injuries, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine VanDerwerker, DPT, PhD (843-792-5047, vanderwe@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as assessed by number of adverse events (time frame: Through the study period (5 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.