Treatment of Depression Post-SCI

Study Overview
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Brief Summary
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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.

Official Title
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Treatment of Depression Post-SCI: Retrospective Analysis and Feasibility Trial

Conditions
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Depression, Spinal Cord Injuries

Intervention / Treatment
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* Device: rTMS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rTMS (Repetitive Transcranial Magnetic Stimulation)<br> | Device: rTMS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as assessed by number of adverse events | Report of adverse and serious adverse events in all participants. | Through the study period (5 weeks) | 
| Number of visits missed | The average of the number of intervention visits missed across all participants | 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. | Baseline, midpoint (Week 3), and post treatment (5 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | 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. | 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. | 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. | 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. | Baseline, midpoint (Week 3), and post treatment (5 weeks) |