Transcranial Direct Current Stimulation for Post-stroke Fatigue
Study Details
Study Description
Brief Summary
The investigators hypothesize that delivery of anodal tDCS to the left frontal head region will reduce fatigue severity following stroke.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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). In a randomly selected subset of both real and sham participants, rs-fMRI will be completed at baseline and post-treatment.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Real tDCS stimulation Subjects randomized to receive real/active electrical stimulation. |
Device: Real Soterix Mini-CT tDCS stimulator
Real transcranial electrical stimulation at 2mA intensity will be delivered to the left dorsolateral prefrontal cortex, 20 minutes/day, 14-day duration.
|
| Sham Comparator: Sham tDCS stimulation Subjects randomized to receive sham/non-activating electrical stimulation. |
Device: Sham Soterix Mini-CT tDCS stimulator
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.
|
Outcome Measures
Primary Outcome Measures
- Mean change from baseline Fatigue Severity Scale - 7 (FSS-7) [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))]
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.
Secondary Outcome Measures
- Mean change from baseline Stroke Specific Quality Of Life scale (SS-QOL) [Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)]
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.
- Mean change from baseline Patient Health Questionnaire - 9 (PHQ-9) [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)]
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.
- Mean change from baseline Generalized Anxiety Disorder - 7 (GAD-7) [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)]
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.
- Mean change from baseline PROMIS-sleep disturbance [Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)]
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.
- Mean change from baseline Symbol Digit Modalities Test (SDMT) [Baseline (Day 1), Post-Treatment (Day 14-21)]
Cognition. A measure of cognitive processing speed and attention. Scores range from 0-120, with higher scores better performance.
- Mean change from baseline AX- continuous performance task (AX-CPT) [Baseline (Day 1), Post-Treatment (Day 14-21)]
Cognition. A computerized test that measures working and long-term memory, with scores ranging from 0-144 for number correct. Response time is also recorded. A higher total number correct score indicates better performance.
- Mean change from baseline Montreal cognitive assessment (MoCA) [Baseline (Day 1), Post-Treatment (Day 14-21)]
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.
- Mean Client Satisfaction Questionnaire - 8 (CSQ-8) [During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)]
Feasibility. This tool is a self-report measure participant satisfaction with the intervention. Scored 8-32 with higher scores indicating greater satisfaction.
- Mean change from baseline Frenchay activities index [Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)]
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.
- Change in resting state brain functional connectivity. [Baseline (Day 1), Post-treatment (Day 14-21)]
Change in functional connectivity in the active vs. the sham arms assessed by a resting state functional magnetic resonance imaging scan (rs-fMRI).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female patients aged >18 years
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Greater than 3 months from first hemorrhagic or ischemic stroke (subacute to chronic), confirmed through neuroimaging (CT or MRI).
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Fatigue severity score average >4 (severe fatigue)
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Willingness to remain stable on pharmacologic therapy through the duration of the study.
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Availability of a caregiver, family member, or friend to be present during the administration of the tDCS intervention.
Exclusion Criteria:
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Metal in the head (except mouth) or implanted cranial or thoracic devices (i.e. pacemaker, DBS stimulator)
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History of seizure
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History of moderate to severe traumatic brain injury
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A score of 10 or more on the PHQ-9 or GAD-7 scale, suggestive of moderate to severe depression/anxiety.
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A score of less than 21 on the MoCA suggesting major neurocognitive disorder.
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Signs of skin rash, infection, or laceration in the supraorbital region where the tDCS will be applied.
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Inability to provide informed consent
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Other major neurological, medical, or psychiatric illnesses that could confound results in the opinion of the site investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106 | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Weill Medical College of Cornell University
Investigators
- Principal Investigator: Joan M Stilling, MD, MS, Weill Medical College of Cornell University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-11025409