Treatment of Depression Post-SCI

Medical University of South Carolina (MUSC)

Status: Enrolling

Conditions: Spinal Cord Injuries; Depression

Treatments: Device: rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT04263285

00086228

Details and patient eligibility

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). 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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

rTMS (Repetitive Transcranial Magnetic Stimulation)

Experimental group

Treatment:

Device: rTMS