Transcranial Direct Current Stimulation for Post-stroke Fatigue

NCT ID: NCT05816603

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-23
• Study Completion Date: 2027-12-31

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.

Conditions

Fatigue; Stroke Rehabilitaion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Real tDCS stimulation

Subjects randomized to receive real/active electrical stimulation.

Group Type: EXPERIMENTAL

Real Soterix Mini-CT tDCS stimulator

Intervention Type: DEVICE

Real transcranial electrical stimulation at 2mA intensity will be delivered to the left dorsolateral prefrontal cortex, 20 minutes/day, 14-day duration.

Sham tDCS stimulation

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

Group Type: SHAM_COMPARATOR

Sham Soterix Mini-CT tDCS stimulator

Intervention Type: 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.

Interventions

Real Soterix Mini-CT tDCS stimulator

Real transcranial electrical stimulation at 2mA intensity will be delivered to the left dorsolateral prefrontal cortex, 20 minutes/day, 14-day duration.

Intervention Type: DEVICE

Sham Soterix Mini-CT tDCS stimulator

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joan M Stilling, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Raquel Queiruga, M.A.

Role: CONTACT

rqu4002@med.cornell.edu

(212) 746-1509

Facility Contacts

Raquel Queiruga, M.A.

Role: primary

rqu4002@med.cornell.edu

212-746-1509

Other Identifiers

22-11025409

Identifier Type: -

Identifier Source: org_study_id