Clinical trial NCT05816603: Transcranial Direct Current Stimulation for Post-stroke Fatigue
Official title: Home-based Post-stroke Fatigue Treatment Using Transcranial Direct Current Stimulation (tDCS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Fatigue
Stroke Rehabilitaion
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2023-04-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mean change from baseline Fatigue Severity Scale - 7 (FSS-7)
timeFrame: 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:
measure: Mean change from baseline Stroke Specific Quality Of Life scale (SS-QOL)
timeFrame: Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)
measure: Mean change from baseline Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: 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: Mean change from baseline Generalized Anxiety Disorder - 7 (GAD-7)
timeFrame: 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: Mean change from baseline PROMIS-sleep disturbance
timeFrame: Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)
measure: Mean change from baseline Symbol Digit Modalities Test (SDMT)
timeFrame: Baseline (Day 1), Post-Treatment (Day 14-21)
measure: Mean change from baseline Test of Variables of Attention (T.O.V.A)
timeFrame: Baseline (Day 1), Post-Treatment (Day 14-21)
measure: Mean change from baseline Montreal cognitive assessment (MoCA)
timeFrame: Baseline (Day 1), Post-Treatment (Day 14-21)
measure: Mean Client Satisfaction Questionnaire - 8 (CSQ-8)
timeFrame: During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)
measure: Mean change from baseline Frenchay activities index
timeFrame: Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)
measure: Change in resting state brain functional connectivity.
timeFrame: Baseline (Day 1), Post-treatment (Day 14-21)
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Joan M Stilling, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: