Transcranial Direct Current Stimulation for Post-stroke Fatigue

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT05816603
Phase
PHASE2
Status
Recruiting
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Conditions

  • Fatigue
  • Stroke Rehabilitaion

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

The investigators hypothesize that delivery of anodal tDCS to the left frontal head region will reduce fatigue severity following stroke.

Key Dates

Start date
May 23, 2023
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Real tDCS stimulation
    Subjects randomized to receive real/active electrical stimulation.
  • Sham Comparator: Sham tDCS stimulation
    Subjects randomized to receive sham/non-activating electrical stimulation.

Primary Outcome Measure

Mean change from baseline Fatigue Severity Scale - 7 (FSS-7) [ 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)) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106New YorkNew York10065
Zhiyan Yang, M.A.
[email protected]
(212) 746-1509
Joan Stilling, MD, MS (PRINCIPAL_INVESTIGATOR)

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By research site
Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106· New York, NY

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