Dosing rTMS for Depression Post-SCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorVA Office of Research and Development
About this trial
Depression is a leading cause of disability worldwide and is more commonly seen in individual's post-spinal cord injury (SCI) than in the general population. Depression post-SCI impacts an individuals' quality of life and recovery. It has been reported that among Veterans with an SCI, those without depression live longer than those with depression. Thus, depression must be treated appropriately. Repetitive transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression, but dosing is based on a motor response or movement in the thumb. Over half of individuals with SCI have some degree of arm or hand impairment, so these individuals might not be eligible for rTMS, or they may receive the wrong dose. This study proposes clinical trial in individuals with depression post-SCI to assess the anti-depressant effect of a novel technique to dose rTMS that does not require a motor response in the thumb. By gaining a better understanding of the application of rTMS for depression post-SCI, the investigators aim to advance the rehabilitative care of Veterans.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
cervical or thoracic spinal cord injury at least 6 months prior with AIS A, B, C, or D;
18 - 60 years of age;
major depressive disorder, as identified by Structured Clinical Interview for DSM-V;
Hamilton Depression Rating Scale-17 score > 18;
Disqualifiers
concomitant neurologic diseases/disorders or dementia;
cognitive impairment (Montreal Cognitive Assessment <17);
history of psychosis or other Axis I disorder that is primary;
positive screen for bipolar disorder through the Mini-International Neuropsychiatric Interview;
Trial design
Design model
Parallel
Treatments tested in this trial
repetitive transcranial magnetic stimulation--Active
DeviceRepetitive transcranial magnetic stimulation (rTMS) is a type of non-invasive brain stimulation. An active coil will be used to administer the active rTMS.
repetitive transcranial magnetic stimulation--Sham
DeviceRepetitive transcranial magnetic stimulation (rTMS) is a type of non-invasive brain stimulation. A sham coil will be used to administer the sham rTMS.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Active rTMSExperimental treatment 1 intervention
Group B: Sham rTMSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in Hamilton Depression Rating Scale-17 (HAM-D17) score immediately post-intervention
The Hamilton Rating Scale for Depression (HAM-D17) is the most widely used tool to assess the severity of depressive symptoms, once diagnosed, and will be used in this study. The HAM-D17 is a semi-structured interview style questionnaire that asks about one's experience with seventeen different depressive symptoms over the past week. Total HAM-D17 scores range from no depressive symptoms (HAM-D17 = 0-7); mild (HAM-D17 = 8-16), moderate (HAM-D17 = 17-23) or severe depressive symptoms (HAMD-D17 = 24).
Time frame
Baseline; Following Week 2 of 6-week intervention Following Week 4 of 6-week intervention; Immediately post-intervention; 12-weeks post-intervention; 24-weeks post-interventionSecondary outcomes
1
Change from baseline in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) at timepoints noted below
The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) is a 16-item questionnaire that asks about the degree of enjoyment and satisfaction in various are of daily functioning, like physical health/activity, mood, work, household duties, school/coursework, leisure time activity, and social relationships. Answers are scored from 1 (very poor) to 5 (very good). It is a valid and reliable measure often used in psychiatric research but has been used in SCI research for neuropathic pain.
Time frame
Baseline; Following Week 2 of 6-week intervention Following Week 4 of 6-week intervention; Immediately post-intervention; 12-weeks post-intervention; 24-weeks post-intervention2
Change from baseline in Sheehan Disability Scale (SDS) Score at timepoints noted below
Sheehan Disability Scale (SDS): The SDS is a three-item questionnaire that asks how depressive symptoms have impacted work/school, social, and family. It is based on a 10-point scale, where 0 = no disruption to 10 = extreme disruption. This outcome use used in the only randomized control trial for an antidepressant post-SCI.
Time frame
Baseline; Following Week 2 of 6-week intervention Following Week 4 of 6-week intervention; Immediately post-intervention; 12-weeks post-intervention; 24-weeks post-intervention3
Change from baseline in Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI) Score at timepoints noted below
Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI) is used to assess physical activity levels of individuals with a spinal cord injury. This is a 3-item questionnaire that asks one to report the number of days and minutes of mild, moderate, and heavy-intensity leisure-time physical activity performed over the previous seven days. This is a valid and reliable measure in the SCI population.
Time frame
Baseline; Following Week 2 of 6-week intervention Following Week 4 of 6-week intervention; Immediately post-intervention; 12-weeks post-intervention; 24-weeks post-intervention4
Change from baseline in Craig Handicap Assessment and Reporting Tool - Short Form (CHART-SF) Score at timepoints noted below
Craig Handicap Assessment and Reporting Tool - Short Form (CHART-SF) assesses how an individual with a disability fulfills roles in six domains, physical independence, cognitive independence, mobility, occupation, social integration, and economic self-sufficiency. It is a valid and reliable measure post-spinal cord injury. The total score ranges from 0 - 600, with a higher score indicating greater independent functioning and higher social and community participation.
Time frame
Baseline; Following Week 2 of 6-week intervention Following Week 4 of 6-week intervention; Immediately post-intervention; 12-weeks post-intervention; 24-weeks post-interventionSponsors and contacts
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Source ClinicalTrials.gov