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FatiguePhase 2NCT05816603

Transcranial Direct Current Stimulation for Post-stroke Fatigue

A Phase 2 study testing Real Soterix Mini-CT tDCS stimulator in people with Fatigue and Stroke Rehabilitaion, run by Weill Medical College of Cornell University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Fatigue, Stroke Rehabilitaion
What is being tested?
Real Soterix Mini-CT tDCS stimulator
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteUnited States
Study dates
23 May 2023to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhiyan Yang, M.A. contact

(212) 746-1509

rehabresearch@med.cornell.edu

United States1 site, 1 recruiting

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

    New York, New York, 10065

    Zhiyan Yang, M.A., (212) 746-1509, rehabresearch@med.cornell.edu

    Joan Stilling, MD, MS

    Recruiting

Other trials in United States

About this study

Official title: Home-based Post-stroke Fatigue Treatment Using Transcranial Direct Current Stimulation (tDCS)

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

Read the 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.

Being tested
Real Soterix Mini-CT tDCS stimulator, Sham Soterix Mini-CT tDCS stimulator
Medical subject headings
Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Real Soterix Mini-CT tDCS stimulatorDevice

    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 stimulatorDevice

    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 groups in NCT05816603
Study groupRoleWhat they receive
Real tDCS stimulationExperimentalSubjects randomized to receive real/active electrical stimulation.
Receives: Device: Real Soterix Mini-CT tDCS stimulator
Sham tDCS stimulationSham comparatorSubjects randomized to receive sham/non-activating electrical stimulation.
Receives: Device: Sham Soterix Mini-CT tDCS stimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)

  5. Mean change from baseline Symbol Digit Modalities Test (SDMT)

    Cognition. A measure of cognitive processing speed and attention. Scores range from 0-120, with higher scores better performance.

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

  6. Mean change from baseline Test of Variables of Attention (T.O.V.A)

    Cognition. A computerized test that measures short-term memory, with scores from 85-115 indicating a normal result. Response time, response time variability, commissions, and omissions are also recorded. A higher total number correct score indicates better performance.

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

  7. Mean change from baseline Montreal cognitive assessment (MoCA)

    Cognition. A brief screening tool to assess global cognitive functioning and detect mild cognitive dysfunction. Scored from 0-30 with higher score indicating better performance.

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

  8. Mean Client Satisfaction Questionnaire - 8 (CSQ-8)

    Feasibility. This tool is a self-report measure participant satisfaction with the intervention. Scored 8-32 with higher scores indicating greater satisfaction.

    Measured: During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)

  9. Mean change from baseline Frenchay activities index

    Activities of Daily Living (ADLs). A measure of instrumental ADLs (domestic chores, leisure/work, outdoor activities) for individuals recovering from stroke. Scored from 15-60 with higher score indicating improved functioning.

    Measured: Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)

  10. Change in resting state brain functional connectivity.

    Change in functional connectivity in the active vs. the sham arms assessed by a resting state functional magnetic resonance imaging scan (rs-fMRI).

    Measured: Baseline (Day 1), Post-treatment (Day 14-21)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start23 May 2023
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05816603
Sponsor's protocol ID
22-11025409
Status last verified
Feb 2026
First submitted
3 Apr 2023
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: All of the participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices)

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Real Soterix Mini-CT tDCS stimulator in people with Fatigue and Stroke Rehabilitaion, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhiyan Yang, M.A. ((212) 746-1509, rehabresearch@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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))). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05816603.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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