Treatment of Depression Post-SCI

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04263285
• Other study ID #: 00086228
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: September 2025

Study information

• Verified date: December 2023
• Source: Medical University of South Carolina
• Contact: Catherine VanDerwerker, DPT, PhD
• Phone: 843-792-5047
• Email: vanderwe[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Spinal Cord Injuries

Intervention

Device:
• rTMS
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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	The Craig H. Neilsen Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as assessed by number of adverse events	Report of adverse and serious adverse events in all participants.	Through the study period (5 weeks)
Primary	Number of visits missed	The average of the number of intervention visits missed across all participants	Throughout the treatment period (4 weeks)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)