Transcranial Direct Current Stimulation for Post-stroke Fatigue
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University
About this trial
The investigators hypothesize that delivery of anodal tDCS to the left frontal head region will reduce fatigue severity following stroke.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Real Soterix Mini-CT tDCS stimulator
DeviceReal transcranial electrical stimulation at 2mA intensity will be delivered to the left dorsolateral prefrontal cortex, 20 minutes/day, 14-day duration.
Sham Soterix Mini-CT tDCS stimulator
DeviceSham 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Real tDCS stimulationExperimental treatment 1 intervention
Group B: Sham tDCS stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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))Secondary outcomes
1
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.
Time frame
Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)2
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.
Time frame
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)3
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.
Time frame
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)4
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.
Time frame
Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Weill Medical College of Cornell University
Lead sponsor
American Heart Association
Collaborator
Source ClinicalTrials.gov