StrokeNCT06088914
Behavioral and Neural Correlates of Post-Stroke Fatigue
A study testing Anodal transcranial direct current stimulation in people with Stroke and Fatigue, run by Texas Woman's University at 1 site in United States.
Trial summary
The goal of this phase I/II clinical trial is to determine the behavioral and neural effects of 5-daily transcranial direct current stimulation on post-stroke fatigue. The three aims are: Aim 1: Investigate the behavioral effect of 5 daily sessions of anodal tDCS over the ipsilesional M1 on PSF. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Anodal transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2023to 28 Feb 2027
- Phase
- Interventional
- 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
- be at least 18 years old;
- have a history of unilateral stroke ≥ 3 months prior to enrollment to ensure stability;
- have an average score ≥ 4 on FSS;
- have some movement capability in the more affected arm (upper extremity Fugl-Meyer(FMUE) ≥ 28) to ensure they can perform the reaching task;
- be able to follow three-step commands.
Who cannot join
- acute medical problems;
- the presence of any contraindication to tDCS, MRI or TMS;
- the presence of significant depression (score > 10 on the Patient Health Questionnaire-9);
- significant pain in the upper extremities that interferes with movements; or
- use of medication which may affect the level of fatigue.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this phase I/II clinical trial is to determine the behavioral and neural effects of 5-daily transcranial direct current stimulation on post-stroke fatigue. The three aims are:
Aim 1: Investigate the behavioral effect of 5 daily sessions of anodal tDCS over the ipsilesional M1 on PSF.
Read more
Aim 2: Investigate the neurophysiological effect of 5 daily sessions of anodal tDCS over the ipsilesional M1.
Aim 3: Determine the relationship between changes in M1 excitability, brain connectivity and changes in PSF.
Participants will receive either a real or sham stimulation for 5 consecutive days and fatigue will be assessed before, immediately after and 1-month after the intervention. Fatigue will be assessed using clinical, behavioral, and neurophysiological outcomes.
Read the detailed description
Up to 85% stroke survivors experience post-stroke fatigue (PSF) defined as intensified perceived effort during activities. PSF is a significant barrier to full participation in rehabilitation and negatively affects quality of life after stroke. Despite its well-known impacts, there are very few targeted interventions for PSF largely due to unclear underlying mechanisms. A few brain stimulation studies have suggested a relationship between primary motor cortex (M1) excitability and PSF. Recent clinical trials using anodal transcranial direct current stimulation (tDCS) to modulate brain excitability reported mixed clinical efficacy in reducing PSF with unclear mechanisms of action.
The proposed research will address the gaps in our knowledge by determining the behavioral and neural correlates of PSF using an experimental design and multimodal approach.
Thirty-two individuals with significant fatigue due stroke will be randomly assigned to receive five consecutive sessions of anodal or sham tDCS. Before and after intervention, participants will complete clinical and behavioral assessments of PSF, brain excitability assessment using transcranial magnetic stimulation, and brain connectivity assessment using resting state functional MRI. In aim 1, the investigators will determine if upregulating M1 excitability via tDCS will reduce PSF assessed by clinical and behavioral markers. Aim 2 will utilize brain stimulation and brain imaging techniques to probe the neurophysiological effect of tDCS on PSF. Aim 3 will explore the relationship between changes in neurophysiological outcomes and changes in PSF.
The long-term goal of the team is to develop evidence based, theory-driven interventions to manage PSF. The proposed study is innovative in that it investigates a relative novel intervention to mitigate PSF and adopts a multimodal approach to examine the underlying mechanisms. The comprehensive research will guide the development of treatment targeted the underlying mechanisms of PSF. In addition to its scientific and clinical significances, the proposed research will achieve its educational goals by fostering a group of student researchers and promoting rigorous research cultures within the investigator's institute.
- Being tested
- Anodal transcranial direct current stimulation, Sham transcranial direct current stimulation
- Medical subject headings
- Stroke, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal transcranial direct current stimulationDevice
Anodal tDCS will be delivered for 5 consecutive days. Participants will receive 2 mA of stimulation for 20 minutes with the anodal electrode placed on the ipsilesional primary motor cortex (M1) and the cathodal electrode placed over the contralateral supraorbital area.
Sham transcranial direct current stimulationDevice
Sham tDCS will be delivered for 5 consecutive days. Participants will receive sham stimulation for 20 minutes with the current intensity ramping down after 30 seconds of stimulation. The anodal electrode placed on the ipsilesional primary motor cortex (M1) and the cathodal electrode placed over the contralateral supraorbital area.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS group | Experimental | Participants will receive anodal tDCS applied to the ipsilesional primary motor cortex. Receives: Device: Anodal transcranial direct current stimulation |
| Sham tDCS | Sham comparator | Participants will receive sham tDCS applied to the ipsilesional primary motor cortex Receives: Device: Sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Scale score
This is a 9 item questionnaire and each item is rated on a Likert scale 1-7. Participants will rate their responseS based on their previous week experience. A higher score suggests more fatigue.
Measured: This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)
Input-output curve slope
Brain excitability will be indexed using the input-output curve slope acquired with single-pulse transcranial magnetic stimulation (TMS)protocol. A greater slope value indicates a greater brain excitability.
Measured: This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)
Secondary outcomes (6)
Borg Rating of Perceived Exertion
Participants will rate their perceived physical effort associated with a reaching task on a scale ranging from 6 to 20. A higher rating suggests higher perceived effort.
Measured: This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)
Functional connectivity of the fronto-striato-thalamic network
Brain functional connectivity will be evaluated using 10-minute resting state functional MRI. A greater correlation coefficient value indicates a greater connectivity within the network.
Measured: This outcome will be assessed at 2 time points during the study, at baseline and immediately after the intervention ( an average of 7 days from baseline).
Fatigue Scale for Motor and Cognitive Function
This is a 20-item questionnaire and each item is rated on a 5-point Likert scale. The questionnaire yields one motor and one cognitive scores. A higher score indicates more fatigue.
Measured: This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)
Visual Analog Scale-Fatigue
This is a 10cm single dimension scale with a higher score indicates a higher level of fatigue.
Measured: This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)
Paas Mental Effort Rating Scale
Participants will rate their perceived mental effort associated with a reaching task on a scale ranging from 1 to 9. A higher score indicates greater mental effort perceived.
Measured: This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)
Paired pulse Transcranial Magnetic Stimulation measures
Brain excitability will also be indexed using neurophysiological measures acquired with paired pulse transcranial magnetic stimulation protocol. These include short-interval intracortical inhibition (SICI) and intracortical facilitation (ICF).
Measured: This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start15 Dec 2023
- Primary completion31 Aug 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Hui-Ting Goh, Principal investigator, Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088914
- Sponsor's protocol ID
- IRB-FY2023-226
- Other IDs
- 1R15HD109737-01A1, R15HD109737
- Status last verified
- Aug 2026
- First submitted
- 18 Sep 2023
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Upon publication of the manuscripts, the de-identified data generated from the project will be made available to qualified researchers outside our research team upon request. The investigators will also deposit the de-identified data to the NICHD Data and Specimen Hub (DASH).
Publications
Liao KC, Christian I, Stewart J, Trudelle-Jackson E, Wang W, Shang T, Goh HT. Behavioral and Neural correlates of Post-STROKE Fatigue: A randomized controlled trial protocol. PLoS One. 2025 Jun 6;20(6):e0324591. doi: 10.1371/journal.pone.0324591. eCollection 2025.
PubMed 40478794
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Neural Correlates of Post-Stroke Fatigue
- ClinicalTrials.gov ID
- NCT06088914
- Acronym / sponsor ID
- IRB-FY2023-226
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this phase I/II clinical trial is to determine the behavioral and neural effects of 5-daily transcranial direct current stimulation on post-stroke fatigue. The three aims are:
Aim 1: Investigate the behavioral effect of 5 daily sessions of anodal tDCS over the ipsilesional M1 on PSF.
Aim 2: Investigate the neurophysiological effect of 5 daily sessions of anodal tDCS over the ipsilesional M1.
Aim 3: Determine the relationship between changes in M1 excitability, brain connectivity and changes in PSF.
Participants will receive either a real or sham stimulation for 5 consecutive days and fatigue will be assessed before, immediately after and 1-month after the intervention. Fatigue will be assessed using clinical, behavioral, and neurophysiological outcomes.
Detailed description
Up to 85% stroke survivors experience post-stroke fatigue (PSF) defined as intensified perceived effort during activities. PSF is a significant barrier to full participation in rehabilitation and negatively affects quality of life after stroke. Despite its well-known impacts, there are very few targeted interventions for PSF largely due to unclear underlying mechanisms. A few brain stimulation studies have suggested a relationship between primary motor cortex (M1) excitability and PSF. Recent clinical trials using anodal transcranial direct current stimulation (tDCS) to modulate brain excitability reported mixed clinical efficacy in reducing PSF with unclear mechanisms of action.
The proposed research will address the gaps in our knowledge by determining the behavioral and neural correlates of PSF using an experimental design and multimodal approach.
Thirty-two individuals with significant fatigue due stroke will be randomly assigned to receive five consecutive sessions of anodal or sham tDCS. Before and after intervention, participants will complete clinical and behavioral assessments of PSF, brain excitability assessment using transcranial magnetic stimulation, and brain connectivity assessment using resting state functional MRI. In aim 1, the investigators will determine if upregulating M1 excitability via tDCS will reduce PSF assessed by clinical and behavioral markers. Aim 2 will utilize brain stimulation and brain imaging techniques to probe the neurophysiological effect of tDCS on PSF. Aim 3 will explore the relationship between changes in neurophysiological outcomes and changes in PSF.
The long-term goal of the team is to develop evidence based, theory-driven interventions to manage PSF. The proposed study is innovative in that it investigates a relative novel intervention to mitigate PSF and adopts a multimodal approach to examine the underlying mechanisms. The comprehensive research will guide the development of treatment targeted the underlying mechanisms of PSF. In addition to its scientific and clinical significances, the proposed research will achieve its educational goals by fostering a group of student researchers and promoting rigorous research cultures within the investigator's institute.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS group | Experimental | Device: Anodal transcranial direct current stimulationParticipants will receive anodal tDCS applied to the ipsilesional primary motor cortex. |
| Sham tDCS | Sham comparator | Device: Sham transcranial direct current stimulationParticipants will receive sham tDCS applied to the ipsilesional primary motor cortex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- be at least 18 years old;
- have a history of unilateral stroke ≥ 3 months prior to enrollment to ensure stability;
- have an average score ≥ 4 on FSS;
- have some movement capability in the more affected arm (upper extremity Fugl-Meyer(FMUE) ≥ 28) to ensure they can perform the reaching task;
- be able to follow three-step commands.
Key exclusion criteria (5 listed)
- acute medical problems;
- the presence of any contraindication to tDCS, MRI or TMS;
- the presence of significant depression (score > 10 on the Patient Health Questionnaire-9);
- significant pain in the upper extremities that interferes with movements; or
- use of medication which may affect the level of fatigue.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal transcranial direct current stimulationAnodal tDCS will be delivered for 5 consecutive days. Participants will receive 2 mA of stimulation for 20 minutes with the anodal electrode placed on the ipsilesional primary motor cortex (M1) and the cathodal electrode placed over the contralateral supraorbital area. | Device | Anodal tDCS group |
| Sham transcranial direct current stimulationSham tDCS will be delivered for 5 consecutive days. Participants will receive sham stimulation for 20 minutes with the current intensity ramping down after 30 seconds of stimulation. The anodal electrode placed on the ipsilesional primary motor cortex (M1) and the cathodal electrode placed over the contralateral supraorbital area. | Device | Sham tDCS |
Primary outcome
Fatigue Severity Scale score
Time frame: This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)
This is a 9 item questionnaire and each item is rated on a Likert scale 1-7. Participants will rate their responseS based on their previous week experience. A higher score suggests more fatigue.
Input-output curve slope
Time frame: This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)
Brain excitability will be indexed using the input-output curve slope acquired with single-pulse transcranial magnetic stimulation (TMS)protocol. A greater slope value indicates a greater brain excitability.
6 secondary outcomes
Borg Rating of Perceived Exertion
Time frame: This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)
Functional connectivity of the fronto-striato-thalamic network
Time frame: This outcome will be assessed at 2 time points during the study, at baseline and immediately after the intervention ( an average of 7 days from baseline).
Fatigue Scale for Motor and Cognitive Function
Time frame: This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)
Visual Analog Scale-Fatigue
Time frame: This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)
Paas Mental Effort Rating Scale
Time frame: This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)
Paired pulse Transcranial Magnetic Stimulation measures
Time frame: This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Derived from this study: PubMed 40478794Liao KC, Christian I, Stewart J, Trudelle-Jackson E, Wang W, Shang T, Goh HT. Behavioral and Neural correlates of Post-STROKE Fatigue: A randomized controlled trial protocol. PLoS One. 2025 Jun 6;20(6):e0324591. doi: 10.1371/journal.pone.0324591. eCollection 2025.
- Individual participant dataSharing planned: Yes. Upon publication of the manuscripts, the de-identified data generated from the project will be made available to qualified researchers outside our research team upon request. The investigators will also deposit the de-identified data to the NICHD Data and Specimen Hub (DASH).
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui-Ting Goh principal investigator
Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal transcranial direct current stimulation in people with Stroke and Fatigue, run by Texas Woman's 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 5 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale score (time frame: This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)). The study lists 2 primary outcomes in all. 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 NCT06088914, which also lists 1 linked publication.
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 7 Aug 2026.