StrokeNCT06810817
Transcranial Direct Current Stimulation and Cognitive Behavioural Programme on Post-stroke Fatigue
A study testing tDCS & cognitive behavioral programme with home-based physical training and physical training in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This study aims to evaluate the effect of transcranial direct current stimulation and cognitive behavioural programme on fatigue and its related outcomes among people with stroke. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- tDCS & cognitive behavioral programme with home-based physical training and physical training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteHong Kong
- Study dates
- 28 Oct 2024to Dec 2026
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with stroke at least 6 months ago
- Fatigue Assessment Scale score ≥20
- cognitively intact
Who cannot join
- Unstable medical conditions leading to fatigue
- Under any clinical trials
- with any other neurological diseases
- history of transient ischemic attack
- Contraindications to tDCS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Shamay NG, 852-2766-4889, shamay.ng@polyu.edu.hk
About this study
Official title: The Effects of Transcranial Direct Current Stimulation and Cognitive Behavioural Programme on Post-stroke Fatigue
This study aims to evaluate the effect of transcranial direct current stimulation and cognitive behavioural programme on fatigue and its related outcomes among people with stroke.
Read the detailed description
This study will adopt a randomized controlled trial. Participants will be randomized into one of the 3 groups. One group will receive transcranial direct current stimulation and cognitive behavioural programme with home-based physical training. Another group will receive sham transcranial direct current stimulation and cognitive behavioural programme with home-based physical training. One group will receive home-based physical training only.
- Conditions
- Stroke
- Being tested
- tDCS & cognitive behavioral programme with home-based physical training, sham tDCS & cognitive behavioral programme with home-based physical training, physical training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS & cognitive behavioral programme with home-based physical trainingCombination product
Participants will receive 16 sessions of tDCS and 7 sessions of cognitive behavioral programme over 8 weeks and have physical training at home for 8 weeks.
sham tDCS & cognitive behavioral programme with home-based physical trainingBehavioural
Participants will receive 16 sessions of sham-tDCS and 7 sessions of cognitive behavioral programme over 8 weeks and have physical training at home for 8 weeks.
physical trainingBehavioural
Participants will have physical training at home for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| tDCS and cognitive behavioural programme with physical training | Experimental | Not described Receives: Combination Product: tDCS & cognitive behavioral programme with home-based physical training |
| sham tDCS and cognitive behavioural programme with physical training | Active comparator | Not described Receives: Behavioral: sham tDCS & cognitive behavioral programme with home-based physical training |
| physical training | Active comparator | Not described Receives: Behavioral: physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Assessment Scale
Measured: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
Secondary outcomes (6)
Pittsburgh Sleep Quality Index
Measured: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
Geriatric Depression Scale
Measured: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
Reintegration to Normal Living Index
Measured: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
Cardio-ankle vascular index
Measured: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
performance fatigue index
Measured: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
psychomotor vigilance task
Measured: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start28 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shamay Ng, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810817
- Sponsor's protocol ID
- HSEARS20240310002
- Status last verified
- Sep 2026
- First submitted
- 28 Jan 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transcranial Direct Current Stimulation and Cognitive Behavioural Programme on Post-stroke Fatigue
- ClinicalTrials.gov ID
- NCT06810817
- Acronym / sponsor ID
- HSEARS20240310002
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Feb 2025 (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.
This study aims to evaluate the effect of transcranial direct current stimulation and cognitive behavioural programme on fatigue and its related outcomes among people with stroke.
Detailed description
This study will adopt a randomized controlled trial. Participants will be randomized into one of the 3 groups. One group will receive transcranial direct current stimulation and cognitive behavioural programme with home-based physical training. Another group will receive sham transcranial direct current stimulation and cognitive behavioural programme with home-based physical training. One group will receive home-based physical training only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS and cognitive behavioural programme with physical training | Experimental | Combination Product: tDCS & cognitive behavioral programme with home-based physical training |
| sham tDCS and cognitive behavioural programme with physical training | Active comparator | Behavioral: sham tDCS & cognitive behavioral programme with home-based physical training |
| physical training | Active comparator | Behavioral: physical training |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed with stroke at least 6 months ago
- Fatigue Assessment Scale score ≥20
- cognitively intact
Key exclusion criteria (5 listed)
- Unstable medical conditions leading to fatigue
- Under any clinical trials
- with any other neurological diseases
- history of transient ischemic attack
- Contraindications to tDCS
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 |
|---|---|---|
| tDCS & cognitive behavioral programme with home-based physical trainingParticipants will receive 16 sessions of tDCS and 7 sessions of cognitive behavioral programme over 8 weeks and have physical training at home for 8 weeks. | Combination product | tDCS and cognitive behavioural programme with physical training |
| sham tDCS & cognitive behavioral programme with home-based physical trainingParticipants will receive 16 sessions of sham-tDCS and 7 sessions of cognitive behavioral programme over 8 weeks and have physical training at home for 8 weeks. | Behavioural | sham tDCS and cognitive behavioural programme with physical training |
| physical trainingParticipants will have physical training at home for 8 weeks. | Behavioural | physical training |
Primary outcome
Fatigue Assessment Scale
Time frame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
6 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
Geriatric Depression Scale
Time frame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
Reintegration to Normal Living Index
Time frame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
Cardio-ankle vascular index
Time frame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
performance fatigue index
Time frame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
psychomotor vigilance task
Time frame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
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 17 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS & cognitive behavioral programme with home-based physical training and physical training in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 3 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: looking for participants now, as of the sponsor's last update on 17 Sep 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 Hong Kong. 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. 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?
Contact Shamay NG (852-2766-4889, shamay.ng@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Assessment Scale (time frame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026; AzTrials last refreshed its copy on 28 Oct 2026.