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Treatment of Depression Post-SCI

Primary Purpose

Depression, Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
rTMS
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rTMS (Repetitive Transcranial Magnetic Stimulation)

Arm Description

Outcomes

Primary Outcome Measures

Safety as assessed by number of adverse events
Report of adverse and serious adverse events in all participants.
Number of visits missed
The average of the number of intervention visits missed across all participants
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.

Secondary Outcome Measures

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.
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).
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.
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.
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.
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.
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.

Full Information

First Posted
February 4, 2020
Last Updated
March 15, 2023
Sponsor
Medical University of South Carolina
Collaborators
The Craig H. Neilsen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04263285
Brief Title
Treatment of Depression Post-SCI
Official Title
Treatment of Depression Post-SCI: Retrospective Analysis and Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
The Craig H. Neilsen Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rTMS (Repetitive Transcranial Magnetic Stimulation)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety as assessed by number of adverse events
Description
Report of adverse and serious adverse events in all participants.
Time Frame
Through the study period (5 weeks)
Title
Number of visits missed
Description
The average of the number of intervention visits missed across all participants
Time Frame
Throughout the treatment period (4 weeks)
Title
Change in depressive symptoms as assessed by the Hamilton Rating Scale for Depression
Description
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.
Time Frame
Baseline, midpoint (Week 3), and post treatment (5 weeks)
Secondary Outcome Measure Information:
Title
Change in depressive symptoms as assessed by the Montgomery- Asberg Depression Rating Scale (MADRS)
Description
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.
Time Frame
Baseline, midpoint (Week 3), and post treatment (5 weeks)
Title
Change in the impact depressive symptoms have on one's life as assessed by the Sheehan Disability Scale.
Description
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).
Time Frame
Baseline, midpoint (Week 3), and post treatment (5 weeks)
Title
Change in subjective well-being based on the Satisfaction With Life Scale.
Description
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.
Time Frame
Baseline and post treatment (5 weeks)
Title
Change in physical activity based on the Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury
Description
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.
Time Frame
Baseline and post treatment (5 weeks)
Title
Change in function as assessed by the Spinal Cord Independence Measure III-Self Report.
Description
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.
Time Frame
Baseline and post treatment (5 weeks)
Title
Change in function and daily activities as assessed by the Craig Handicap Assessment and Reporting Tool-Short Form
Description
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.
Time Frame
Baseline and post treatment (5 weeks)
Title
Change depressive symptoms as assessed by the Patient Health Questionnaire-9 score
Description
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.
Time Frame
Baseline, midpoint (Week 3), and post treatment (5 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine VanDerwerker, DPT, PhD
Phone
843-792-5047
Email
vanderwe@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine VanDerwerker, DPT, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine VanDerwerker, DPT, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Treatment of Depression Post-SCI

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