Treatment of Depression Post-SCI
Treatment of Depression Post-SCI: Retrospective Analysis and Feasibility Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Catherine VanDerwerker, DPT, PhD
- Phone Number: 843-792-5047
- Email: vanderwe@musc.edu
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Recruiting
- Medical University of South Carolina
-
Contact:
- Catherine VanDerwerker, DPT, PhD
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: rTMS (Repetitive Transcranial Magnetic Stimulation)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Through the study period (5 weeks)
|
|
Number of visits missed
Time Frame: Throughout the treatment period (4 weeks)
|
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
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.
|
Baseline, midpoint (Week 3), and post treatment (5 weeks)
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in depressive symptoms as assessed by the Montgomery- Asberg Depression Rating Scale (MADRS)
Time Frame: Baseline, midpoint (Week 3), and post treatment (5 weeks)
|
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.
Time Frame: Baseline, midpoint (Week 3), and post treatment (5 weeks)
|
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.
Time Frame: Baseline and post treatment (5 weeks)
|
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
Time Frame: Baseline and post treatment (5 weeks)
|
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.
Time Frame: Baseline and post treatment (5 weeks)
|
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
Time Frame: Baseline and post treatment (5 weeks)
|
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
Time Frame: Baseline, midpoint (Week 3), and post treatment (5 weeks)
|
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.
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Baseline, midpoint (Week 3), and post treatment (5 weeks)
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Catherine VanDerwerker, DPT, PhD, Medical University of South Carolina
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 00086228
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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