Transcranial Direct Current Stimulation for Post-stroke Fatigue

NCT05816603 | Recruiting Phase 2 DMC FDA Device

• 1 other identifier: 22-11025409
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fatigue; Stroke Rehabilitaion

Outcome Measures

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.

  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 (10)

• 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)

• 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)

• 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)

• 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)

• Mean change from baseline Symbol Digit Modalities Test (SDMT)

  Baseline (Day 1), Post-Treatment (Day 14-21)

Study Arms (2)

Real tDCS stimulation

EXPERIMENTAL

Subjects randomized to receive real/active electrical stimulation.

Device: Real Soterix Mini-CT tDCS stimulator

Sham tDCS stimulation

SHAM COMPARATOR

Subjects randomized to receive sham/non-activating electrical stimulation.

Device: Sham Soterix Mini-CT tDCS stimulator

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.

Real tDCS stimulation

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.

Sham tDCS stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• American Heart Association: collaborator

Study Sites (1)

Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joan M Stilling, MD, MS

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiyan Yang, M.A.

CONTACT

(212) 746-1509; rehabresearch@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 18, 2023
• Study Start: May 23, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: To achieve aims in the approved proposal. Proposals may be submitted to the study P.I. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years following publication.

Locations

US (1)