StrokeNCT07151729
Use of Anodal tDCS to Enhance Upper Limb Recovery in Stroke
A study testing Anodal tDCS in people with Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
This will be a randomized, blinded, sham-controlled trial. The medical device used, Soterix Medical 1x1 tDCS stimulator, is capable of delivering either real or sham tDCS and has been used in many randomised controlled trials in stroke patients. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Anodal tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Sep 2025to 31 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First ever unilateral ischaemic or haemorrhagic stroke, as documented by CT or MRI scans
- Age 21-80 years, both males and females
- Within 8 weeks of stroke onset
- Severe weakness of one upper limb, defined by a Shoulder Abduction and Finger Extension (SAFE) score < 5 (Medical Research Council grading)
- Provision of informed consent by patient or a legal guardian in accordance with the local ethics committee guidelines and the Declaration of Helsinki
Who cannot join
- Bilateral hemispheric or cerebellar strokes
- Pre-existing arm pathology (e.g. contracture, severe pain, etc.) on the affected side
- Presence of brain implants, and previous insertion of external ventricular drains.
- Metallic implants at the level of the neck, mouth cavity and below are permitted (e.g. Cardiac stents, dental implants, pacemakers and other metallic objects)
- A history of spontaneous seizures, epilepsy, brain tumour, and cranial surgery
- Severe cognitive impairment (MOCA Score <10) that would hinder sufficient understanding of the instructions
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Tan Tock Seng Hospital - Integrated Care Hub
Singapore, Singapore, 307382
WAI PING ALFRED SENG, MBBS, MRCP, +65 68894580, alfred_seng@ttsh.com.sg
WAI PING ALFRED SENG
About this study
Official title: Use of Anodal Transcranial Direct Current Stimulation to Enhance Upper Limb Recovery in Stroke
This will be a randomized, blinded, sham-controlled trial. The medical device used, Soterix Medical 1x1 tDCS stimulator, is capable of delivering either real or sham tDCS and has been used in many randomised controlled trials in stroke patients.
50 patients with subacute stroke and severe upper limb weakness within 8 weeks of stroke on transfer to TTSH stroke rehab wards will be recruited over a period of 10 months. Recruited patients will be randomized into the intervention and control arms in a 1:1 ratio.
Read the detailed description
The primary objective is to determine the clinical efficacy, technical feasibility and safety of anodal tDCS therapy to the unaffected hemisphere in hospitalized subacute stroke patients with severe arm weakness.
- Conditions
- Stroke
- Being tested
- Anodal tDCS, Sham tDCS
- Keywords
- stroke, tdcs, upper limb
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tDCSDevice
Also called tDCS
This anodal tDCS is applied over the contralateral dorsal premotor cortex (instead of the ipsilateral motor cortex in previous studies).
Sham tDCSDevice
Also called tdcs
Sham tDCS is applied
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Experimental | Anodal tDCS to contralateral dorsal premotor cortex (dPMc) Receives: Device: Anodal tDCS |
| Sham tDCS | Sham comparator | Sham tDCS to contralateral dorsal premotor cortex (dPMc) Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Upper Limb
Fugl-Meyer Upper Limb
Measured: At baseline (Day 0) At end of 10 tDCS sessions (Day 10) At 3 months after the 10th tDCS session (Month 3)
Secondary outcomes (4)
Streamlined Wolf Motor Function Test (sWMFT)
Streamlined Wolf Motor Function Test (sWMFT)
Measured: At baseline (Day 0) At end of 10 tDCS sessions (Day 10) At 3 months after the 10th tDCS session (Month 3)
Functional Independence Measure (FIM)
Functional Independence Measure (FIM) is a widely used objective assessment tool in rehabilitation to evaluate a patient's functional abilities and track their progress. It is a 18-item, 7-level scale, with higher scores indicating greater independence. The total FIM score ranges from 18 to 126.
Measured: At baseline (Day 0) At end of 10 tDCS sessions (Day 10)
EQ5D-5L
The EurolQol 5-Dimension 5-Level (EQ5D-5L) is a widely-used, non-disease specific questionnaire designed to assess a patient's health related quality of life. It serves as a patient-reported outcome instrument, capturing the patient's own perspective on their health. It consists of a descriptive system of five questions (each scored from Level 1 to 5, with a higher score indicating more severe problems) and a visual analogue scale (VAS) for overall health assessment. A higher VAS (from 0 to 100) would indicate a better quality of life.
Measured: At baseline (Day 0) and at 3 months after the 10th tDCS session (Month 3)
Rate of Adverse Events from tDCS
An adverse events questionnaire is administered immediately after each tDCS session. As such, each participant would fill up 10 adverse effects questionnaires after a total of 10 tDCS sessions.
The rate of adverse events from tDCS would be computed from the number of adverse events divided by the total number of tDCS sessions.
Measured: Immediately after each tDCS session (total 10 sessions of tDCS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion31 Dec 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
- Model description
- Randomised controlled trial 1 control group (with sham transcranial direct current stimulation) and 1 intervention group (with real anodal transcranial direct current stimulation)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ng Teng Fong Healthcare Innovation Programme
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151729
- Sponsor's protocol ID
- DSRB 2024-4011
- Status last verified
- May 2025
- First submitted
- 8 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: To protect the privacy of participants. Preparing IPD for sharing can also be time-consuming and resource-intensive.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Anodal Transcranial Direct Current Stimulation to Enhance Upper Limb Recovery in Stroke
- ClinicalTrials.gov ID
- NCT07151729
- Acronym / sponsor ID
- DSRB 2024-4011
- Conditions
- Stroke
- Keywords
- stroke, tdcs, upper limb
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Ng Teng Fong Healthcare Innovation Programme
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Sep 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 will be a randomized, blinded, sham-controlled trial. The medical device used, Soterix Medical 1x1 tDCS stimulator, is capable of delivering either real or sham tDCS and has been used in many randomised controlled trials in stroke patients.
50 patients with subacute stroke and severe upper limb weakness within 8 weeks of stroke on transfer to TTSH stroke rehab wards will be recruited over a period of 10 months. Recruited patients will be randomized into the intervention and control arms in a 1:1 ratio.
Detailed description
The primary objective is to determine the clinical efficacy, technical feasibility and safety of anodal tDCS therapy to the unaffected hemisphere in hospitalized subacute stroke patients with severe arm weakness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial 1 control group (with sham transcranial direct current stimulation) and 1 intervention group (with real anodal transcranial direct current stimulation)
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Experimental | Device: Anodal tDCSAnodal tDCS to contralateral dorsal premotor cortex (dPMc) |
| Sham tDCS | Sham comparator | Device: Sham tDCSSham tDCS to contralateral dorsal premotor cortex (dPMc) |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First ever unilateral ischaemic or haemorrhagic stroke, as documented by CT or MRI scans
- Age 21-80 years, both males and females
- Within 8 weeks of stroke onset
- Severe weakness of one upper limb, defined by a Shoulder Abduction and Finger Extension (SAFE) score < 5 (Medical Research Council grading)
- Provision of informed consent by patient or a legal guardian in accordance with the local ethics committee guidelines and the Declaration of Helsinki
Key exclusion criteria (7 listed)
- Bilateral hemispheric or cerebellar strokes
- Pre-existing arm pathology (e.g. contracture, severe pain, etc.) on the affected side
- Presence of brain implants, and previous insertion of external ventricular drains.
- Metallic implants at the level of the neck, mouth cavity and below are permitted (e.g. Cardiac stents, dental implants, pacemakers and other metallic objects)
- A history of spontaneous seizures, epilepsy, brain tumour, and cranial surgery
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 tDCSAlso: tDCSThis anodal tDCS is applied over the contralateral dorsal premotor cortex (instead of the ipsilateral motor cortex in previous studies). | Device | Anodal tDCS |
| Sham tDCSAlso: tdcsSham tDCS is applied | Device | Sham tDCS |
Primary outcome
Fugl-Meyer Upper Limb
Time frame: At baseline (Day 0) At end of 10 tDCS sessions (Day 10) At 3 months after the 10th tDCS session (Month 3)
Fugl-Meyer Upper Limb
4 secondary outcomes
Streamlined Wolf Motor Function Test (sWMFT)
Time frame: At baseline (Day 0) At end of 10 tDCS sessions (Day 10) At 3 months after the 10th tDCS session (Month 3)
Functional Independence Measure (FIM)
Time frame: At baseline (Day 0) At end of 10 tDCS sessions (Day 10)
EQ5D-5L
Time frame: At baseline (Day 0) and at 3 months after the 10th tDCS session (Month 3)
Rate of Adverse Events from tDCS
Time frame: Immediately after each tDCS session (total 10 sessions of tDCS)
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 3 Sep 2025.
- Individual participant dataSharing planned: No. To protect the privacy of participants. Preparing IPD for sharing can also be time-consuming and resource-intensive.
Related trials for Stroke
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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 Anodal tDCS in people with Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 7 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 3 Sep 2025. 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 Singapore. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Upper Limb (time frame: At baseline (Day 0) At end of 10 tDCS sessions (Day 10) At 3 months after the 10th tDCS session (Month 3)). 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 3 Sep 2025.