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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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The investigators hypothesize that delivery of anodal tDCS to the left frontal head region will reduce fatigue severity following stroke.
The purpose of this study is to investigate transcranial direct current stimulation (tDCS) as a home-based non-pharmacologic intervention for post-stroke fatigue (PSF). Investigators will perform a double-blind, sham-controlled, randomized clinical trial with 24 subjects; 12 will receive sham stimulation and 12 will receive real stimulation. After a baseline assessment, the tDCS device will be applied for 20 minutes, once daily over the left dorsolateral prefrontal cortex (DLPFC), for a total of two weeks. Follow-up assessments with outcome metrics will be completed after the seventh and fourteenth sessions, and one-month following the start date (2 weeks post-treatment). Neuroimaging will be completed at baseline and post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real tDCS stimulation | Experimental | Subjects randomized to receive real/active electrical stimulation. |
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| Sham tDCS stimulation | Sham Comparator | Subjects randomized to receive sham/non-activating electrical stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real Soterix Mini-CT tDCS stimulator | Device | Real transcranial electrical stimulation at 2mA intensity will be delivered to the left dorsolateral prefrontal cortex, 20 minutes/day, 14-day duration. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline Fatigue Severity Scale - 7 (FSS-7) | Fatigue Severity. This seven item scale measures fatigue severity and it's effect on a person's lifestyle and activities. Items are scored on a seven point scale. Minimum score = 7, maximum score = 49 with higher score indicating greater fatigue severity. | Screening (-1 to -14 days), Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline Stroke Specific Quality Of Life scale (SS-QOL) | Quality of Life. Assesses health related quality of life, specific to individuals with stroke. Composed of 49 items, score on a 5 point guttman type scale. Scores range from 49 to 245, with higher score indicating better functioning. | Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiyan Yang, M.A. | Contact | (212) 746-1509 | rehabresearch@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joan M Stilling, MD, MS | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106 | Recruiting | New York | New York | 10065 | United States |
All of the participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices)
Beginning 3 months and ending 5 years following article publication.
To achieve aims in the approved proposal. Proposals may be submitted to the study P.I. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years following publication.
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Sham Soterix Mini-CT tDCS stimulator | Device | Sham stimulation to the left dorsolateral prefrontal cortex, 20 minutes/day, 14-day duration. The device will ramp up and ramp down current delivery from 0 mA -2 mA - 0 mA over 30 seconds at the start of the 20-minute protocol with no active stimulation until the end of the 20 minutes, at which time the 30-second ramp up/ramp down will be repeated. |
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| Mean change from baseline Patient Health Questionnaire - 9 (PHQ-9) | Depression. A multipurpose instrument for screening, measuring, and monitoring severity of depression. Scores range from 0-27, with higher score indicating greater severity of depression. | Screening (-1 to -14 days), Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52) |
| Mean change from baseline Generalized Anxiety Disorder - 7 (GAD-7) | Anxiety. A multipurpose instrument for screening, measuring, and monitoring severity of anxiety. Scores range from 0-21, with higher score indicating greater severity of anxiety. | Screening (-1 to -14 days), Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52) |
| Mean change from baseline PROMIS-sleep disturbance | Sleep. A domain focused self report of global, physical, mental, and social health for those living with a chronic condition. Computer adapted test with higher scores indicating more sleep disturbance. Results reported as a T-score with range from 10-90 based on the United States general population average score of 50 and standard deviation of 10. Higher t-score indicates greater sleep disturbance. | Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52) |
| Mean change from baseline Symbol Digit Modalities Test (SDMT) | Cognition. A measure of cognitive processing speed and attention. Scores range from 0-120, with higher scores better performance. | Baseline (Day 1), Post-Treatment (Day 14-21) |
| Mean change from baseline Test of Variables of Attention (T.O.V.A) | Cognition. A computerized test that measures short-term memory, with scores from 85-115 indicating a normal result. Response time, response time variability, commissions, and omissions are also recorded. A higher total number correct score indicates better performance. | Baseline (Day 1), Post-Treatment (Day 14-21) |
| Mean change from baseline Montreal cognitive assessment (MoCA) | Cognition. A brief screening tool to assess global cognitive functioning and detect mild cognitive dysfunction. Scored from 0-30 with higher score indicating better performance. | Baseline (Day 1), Post-Treatment (Day 14-21) |
| Mean Client Satisfaction Questionnaire - 8 (CSQ-8) | Feasibility. This tool is a self-report measure participant satisfaction with the intervention. Scored 8-32 with higher scores indicating greater satisfaction. | During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52) |
| Mean change from baseline Frenchay activities index | Activities of Daily Living (ADLs). A measure of instrumental ADLs (domestic chores, leisure/work, outdoor activities) for individuals recovering from stroke. Scored from 15-60 with higher score indicating improved functioning. | Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52) |
| Change in resting state brain functional connectivity. | Change in functional connectivity in the active vs. the sham arms assessed by a resting state functional magnetic resonance imaging scan (rs-fMRI). | Baseline (Day 1), Post-treatment (Day 14-21) |