Transcranial Direct Current Stimulation for Post-stroke Fatigue
- Conditions
- FatigueStroke Rehabilitaion
- Interventions
- Device: Real Soterix Mini-CT tDCS stimulatorDevice: Sham Soterix Mini-CT tDCS stimulator
- Registration Number
- NCT05816603
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
The investigators hypothesize that delivery of anodal tDCS to the left frontal head region will reduce fatigue severity following stroke.
- 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). Neuroimaging will be completed at baseline and post-treatment.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- Male or female patients aged >18 years
- Greater than 3 months from first hemorrhagic or ischemic stroke (subacute to chronic), confirmed through neuroimaging (CT or MRI).
- Fatigue severity score average >4 (severe fatigue)
- Willingness to remain stable on pharmacologic therapy through the duration of the study.
- Availability of a caregiver, family member, or friend to be present during the administration of the tDCS intervention.
- Metal in the head (except mouth) or implanted cranial or thoracic devices (i.e. pacemaker, DBS stimulator)
- History of seizure
- History of moderate to severe traumatic brain injury
- A score of 10 or more on the PHQ-9 or GAD-7 scale, suggestive of moderate to severe depression/anxiety.
- A score of less than 21 on the MoCA suggesting major neurocognitive disorder.
- Signs of skin rash, infection, or laceration in the supraorbital region where the tDCS will be applied.
- Inability to provide informed consent
- Other major neurological, medical, or psychiatric illnesses that could confound results in the opinion of the site investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Real tDCS stimulation Real Soterix Mini-CT tDCS stimulator Subjects randomized to receive real/active electrical stimulation. Sham tDCS stimulation Sham Soterix Mini-CT tDCS stimulator Subjects randomized to receive sham/non-activating electrical stimulation.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Test of Variables of Attention (T.O.V.A) Baseline (Day 1), Post-Treatment (Day 14-21) 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.
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 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.
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 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.
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).
Trial Locations
- Locations (1)
Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106
🇺🇸New York, New York, United States