Treatment of Depression Post-SCI: Retrospective Analysis and Feasibility Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Safety as assessed by number of adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
rTMS (Repetitive Transcranial Magnetic Stimulation)
Intervention: rTMS (Device)
Outcomes
Primary Outcomes
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.
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.
Number of visits missed
Time Frame: Throughout the treatment period (4 weeks)
The average of the number of intervention visits missed across all participants
Secondary Outcomes
- Change in subjective well-being based on the Satisfaction With Life Scale.(Baseline 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 physical activity based on the Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury(Baseline and post treatment (5 weeks))
- 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 function as assessed by the Spinal Cord Independence Measure III-Self Report.(Baseline and post treatment (5 weeks))
- Change in function and daily activities as assessed by the Craig Handicap Assessment and Reporting Tool-Short Form(Baseline and post treatment (5 weeks))
- Change depressive symptoms as assessed by the Patient Health Questionnaire-9 score(Baseline, midpoint (Week 3), and post treatment (5 weeks))
Investigators
Catherine VanDerwerker
Research Associate
Medical University of South Carolina