NCT04263285 · Medical University of South Carolina
Treatment of Depression Post-SCI
What this study is about
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).
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Where
- Charleston, South Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 4, 2026 · Source of record for eligibility and locations