Clinical trial NCT04263285: Treatment of Depression Post-SCI
Official title: Treatment of Depression Post-SCI: Retrospective Analysis and Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Spinal Cord Injuries
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2020-02-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety as assessed by number of adverse events
timeFrame: Through the study period (5 weeks)
measure: Number of visits missed
timeFrame: Throughout the treatment period (4 weeks)
measure: Change in depressive symptoms as assessed by the Hamilton Rating Scale for Depression
timeFrame: Baseline, midpoint (Week 3), and post treatment (5 weeks)
Secondary outcomes:
measure: Change in depressive symptoms as assessed by the Montgomery- Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline, midpoint (Week 3), and post treatment (5 weeks)
measure: Change in the impact depressive symptoms have on one's life as assessed by the Sheehan Disability Scale.
timeFrame: Baseline, midpoint (Week 3), and post treatment (5 weeks)
measure: Change in subjective well-being based on the Satisfaction With Life Scale.
timeFrame: Baseline and post treatment (5 weeks)
measure: Change in physical activity based on the Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury
timeFrame: Baseline and post treatment (5 weeks)
measure: Change in function as assessed by the Spinal Cord Independence Measure III-Self Report.
timeFrame: Baseline and post treatment (5 weeks)
measure: Change in function and daily activities as assessed by the Craig Handicap Assessment and Reporting Tool-Short Form
timeFrame: Baseline and post treatment (5 weeks)
measure: Change depressive symptoms as assessed by the Patient Health Questionnaire-9 score
timeFrame: Baseline, midpoint (Week 3), and post treatment (5 weeks)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Catherine VanDerwerker, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: