StrokeNCT06409143
High-definition Transcranial Electrical Stimulation for Upper Extremity Rehabilitation
A study testing HD-tES, UE rehabilitation and HD-tES (Bilateral) in people with Stroke, run by National Taiwan University Hospital at 3 sites in Taiwan.
Trial summary
Upper limb hemiparesis is the most common sequelae in patients, severely impacting their independence and quality of life. Transcranial electrical stimulation (tCES) is a non-invasive and safe treatment, which uses a low direct current or alternating current to change the excitability of the cerebral cortex. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- HD-tES, UE rehabilitation and HD-tES (Bilateral)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 3 sitesTaiwan
- Study dates
- 15 Aug 2024to 30 Nov 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sub-Project 1 (Healthy)
- Adults aged 18 and above.
- Confirmed right-handedness using the Edinburgh Handedness Inventory.
- Sub-Project 1 (Post-stroke patients)
- Aged 18 and above.
- Diagnosed with stroke.
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- Post-stroke for more than 6 months.
- Unilateral hemiparesis.
- Sub-Project 2 (Subacute-stroke patients)
- Aged 18 and above.
- Diagnosed with stroke.
- Stroke occurred between 7 days to 6 months ago.
- Unilateral hemiparesis.
- Degree of recovery for proximal and distal movements of the affected upper limb is Brunnstrom stage III to V.
- No severe muscle spasticity in any segments of the affected upper limb (Modified Ashworth Scale ≤ 2).
Who cannot join
- Sub-Project 1 (Healthy)
- History of neurological disorders (e.g., stroke, brain tumor, epilepsy), psychiatric disorders (e.g., substance abuse, major depression, schizophrenia, bipolar disorder), or musculoskeletal disorders of the upper limb.
- Contraindications to transcranial electrical stimulation, including history of epilepsy, atrial fibrillation, presence of metal implants, cardiac pacemakers, convexity skull defects, or increased intracranial pressure.
- Skin allergies, contact dermatitis, abnormal pain, hypersensitivity to pain, wounds, or ulcers on the head.
- Participation in other invasive or non-invasive brain stimulation research studies.
- Pregnancy or lactating women. (If female, must be postmenopausal or surgically sterilized. Fertile women must have a negative pregnancy test result. Fertile female patients engaging in heterosexual intercourse, as well as fertile male patients with fertile female partners, must agree to use effective contraception during the trial period and for 4 months after the last dose of the investigational drug, such as oral contraceptives, dual barrier methods, intrauterine devices, or abstain from sexual intercourse during this period; non-fertile women are those who have undergone bilateral oophorectomy or are postmenopausal.)
Show all 36Show fewer
- History of alcohol or substance abuse.
- Damaged skin at the stimulation site, electrode contact, or device wearing site.
- Long-term use of central nervous system affecting medications (such as antidepressants, sedatives) or other medications that may affect seizure threshold.
- Other conditions deemed unsuitable for transcranial electrical or magnetic stimulation by a physician.
- Affiliation with any research institution/execution unit (e.g., students from NTU, Taipei Medical University).
- Sub-Project 1 (Post-stroke patients)
- Contraindications to transcranial electrical stimulation include a history of epilepsy, atrial fibrillation, presence of metal implants, cardiac pacemakers, convexity skull defects, or increased intracranial pressure.
- Skin allergies, contact dermatitis, abnormal pain, hypersensitivity to pain, wounds, or ulcers on the head.
- Severe neurological or psychiatric disorders other than stroke (such as major depression, schizophrenia, substance abuse, organic brain diseases, Parkinson's disease, brain tumors).
- Use of medications that may lower the seizure threshold.
- Undergoing other invasive or non-invasive brain stimulation therapies.
- Pregnancy or lactating women. (If female, must be postmenopausal or surgically sterilized. Fertile women must have a negative pregnancy test result. Fertile female patients engaging in heterosexual intercourse, as well as fertile male patients with fertile female partners, must agree to use effective contraception during the trial period and for 4 months after the last dose of the investigational drug, such as oral contraceptives, dual barrier methods, intrauterine devices, or abstain from sexual intercourse during this period; non-fertile women are those who have undergone bilateral oophorectomy or are postmenopausal.)
- History of alcohol or substance abuse.
- Damaged skin at the stimulation site, electrode contact, or device wearing site.
- Long-term use of central nervous system affecting medications (such as antidepressants, sedatives) or other medications that may affect seizure threshold.
- Other conditions deemed unsuitable for transcranial electrical or magnetic stimulation by a physician.
- Sub-Project 2 (Subacute-stroke patients)
- Contraindications to transcranial electrical stimulation include a history of epilepsy, atrial fibrillation, presence of metal implants, cardiac pacemakers, convexity skull defects, or increased intracranial pressure.
- Skin allergies, contact dermatitis, abnormal pain, hypersensitivity to pain, wounds, or ulcers on the head.
- Severe neurological or psychiatric disorders other than stroke (such as major depression, schizophrenia, substance abuse, organic brain diseases, Parkinson's disease, brain tumors).
- Use of medications that may lower the seizure threshold.
- Other muscle and joint problems affecting upper limb function, such as joint contractures, rheumatoid arthritis, myositis ossificans.
- Severe cognitive impairment or receptive or global aphasia making it difficult to understand instructions.
- Hemineglect (including visual, auditory, or sensory neglect).
- Undergoing other invasive or non-invasive brain stimulation therapies.
- Pregnancy or lactating women. (If female, must be postmenopausal or surgically sterilized. Fertile women must have a negative pregnancy test result. Fertile female patients engaging in heterosexual intercourse, as well as fertile male patients with fertile female partners, must agree to use effective contraception during the trial period and for 4 months after the last dose of the investigational drug, such as oral contraceptives, dual barrier methods, intrauterine devices, or abstain from sexual intercourse during this period; non-fertile women are those who have undergone bilateral oophorectomy or are postmenopausal.)
- History of alcohol or substance abuse.
- Damaged skin at the stimulation site, electrode contact, or device wearing site.
- Long-term use of central nervous system affecting medications (such as antidepressants, sedatives) or other medications that may affect seizure threshold.
- Other conditions deemed unsuitable for transcranial electrical or magnetic stimulation by a physician.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan3 sites, 3 recruiting
- Not yet recruiting
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu
Ying Chun Chen, M.D., 0972656378, yasandy2000@gmail.com
- Not yet recruiting
New Taipei City Tucheng Hospital
New Taipei City
Pei-Chien Hsieh, +886-978-835-703, pudding@cgmh.org.com
- Recruiting
National Taiwan University Hospital
Taipei
Yi-Jing Huang, PhD, +886-911-164-386, yijinghuang@ntu.edu.tw
About this study
Official title: Neural Mechanisms and Augmented Efficacy of High-definition Transcranial Electrical Stimulation on Upper-extremity Function in Patients With Subacute Stroke
Upper limb hemiparesis is the most common sequelae in patients, severely impacting their independence and quality of life. Transcranial electrical stimulation (tCES) is a non-invasive and safe treatment, which uses a low direct current or alternating current to change the excitability of the cerebral cortex. It can induces long-term potentiation-like or long-term depression-like effects, thereby modulating the cortical excitability. In recent years, researchers have developed high-definition (HD) devices, which integrate high definition ring electrode configurations and incorporate direct current with theta burst stimulation waveforms. Diverging from traditional transcranial direct current stimulation (tDCS), which applies weak currents (0.5-2 mA) through two large sponge electrodes (25~35 cm^2) externally to the scalp for widespread non-specific cortical stimulation, HD-tES employs an array of small-area electrodes (1 cm^2) to control current distribution over localized cortical regions, thereby enhancing spatial accuracy. However, there is a lack of studies validating the optimal waveform for HD-tES, as well as clinical evidence in subacute stroke populations. The optimal unilateral versus bilateral stimulation modes and their neurological mechanisms for stroke rehabilitation also remain uncertain.
Read the detailed description
This project comprises two sub-projects:
- Investigation of Neuromodulatory Effects of Stimulation Waveforms and Optimal Stimulation Waveform for Patients with Stroke : a crossover trial will compare the effects of seven high-definition transcranial electrical stimulation (HD-tES) waveforms on neural excitatory or inhibitory activity in healthy adults. These waveforms include three excitatory wave forms (anodal direct current (aDC), intermittent theta burst stimulation (iTBS), and a combination of aDC and iTBS (aDC+iTBS)) and three inhibitory wave forms (cathodal direct current (cDC), continuous theta burst stimulation (cTBS), and a combination of cDC and cTBS (cDC+cTBS)), along with a sham stimulation condition. Changes in cortical excitability over a 2-hour period before and after stimulation will be tracked. Validation of the optimal stimulation waveform for patients with stroke will be conducted through a crossover trial comparing three excitatory HD-tES waveforms for enhancing affected brain activity and three inhibitory HD-tES waveforms for reducing activity in the unaffected hemisphere. Changes in cortical excitability over a 2-hour period before and after stimulation will be monitored.
- Exploration of the Effects of Unilateral and Bilateral HD-tES in Patients with Subacute Stroke: A triple-blind randomized controlled trial will be conducted to compare four neuromodulatory modes combined with conventional upper limb rehabilitation on brain activity and upper limb function in patients with subacute stroke. These modes include excitatory stimulation on the affected hemisphere (based on results from sub-project one, choosing from aDC, iTBS, or aDC+iTBS), inhibitory stimulation on the unaffected hemisphere (based on results from sub-project one, choosing from cDC, cTBS, or cDC+cTBS), simultaneous bilateral stimulation, and sham stimulation.
The primary outcome will focus on upper limb functional activity and upper limb motor function, with other indicators serving as secondary outcomes.
- Conditions
- Stroke
- Being tested
- HD-tES, Sham HD-tES, UE rehabilitation, HD-tES (Bilateral)
- Keywords
- Stroke, High-Definition Transcranial Electrical Stimulation, Upper-limb rehabilitation, Transcranial electrical stimulation, Neuroplasticity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD-tESDevice
The intensity of HD-tES is set at 2 mA, the current intensity ramps up to 2 mA within 5 seconds, remains at 2 mA for 10 minutes, and then ramps down to zero within 5 seconds. For the sham stimulation, the current intensity ramps up and down at the first and last 10 seconds, with the remaining 10 minutes set at 0 mA. The inhibitory and excitatory waveform will be selected based on results of sub-project 1.
Sham HD-tESDevice
The intensity of HD-tES is set at 2 mA, the current intensity ramps up to 2 mA within 5 seconds, remains at 2 mA for 10 minutes, and then ramps down to zero within 5 seconds. For the sham stimulation, the current intensity ramps up and down at the first and last 10 seconds, with the remaining 10 minutes set at 0 mA. The inhibitory and excitatory waveform will be selected based on results of sub-project 1.
UE rehabilitationOther
Upper extremity rehabilitation programs will be selected and graded in accordance with each patient's upper extremity function and specific aims of activities of daily living. Upper extremity rehabilitation will be provided for 60 minutes each time, 5 times a week, lasting for 3 weeks.
HD-tES (Bilateral)Device
The intensity of HD-tES is set at 2 mA, the current intensity ramps up to 2 mA within 5 seconds, remains at 2 mA for 10 minutes, and then ramps down to zero within 5 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Excitatory stimulation on the affected hemisphere & UE rehabilitation | Experimental | 10 minutes sham inhibitory HD-tES over the unaffected hemisphere's M1 followed by 10 minutes of excitatory HD-tES over the affected hemisphere's M1, combined with upper extremity rehabilitation of affected side. Receives: Device: HD-tES; Other: UE rehabilitation |
| Inhibitory stimulation on the unaffected hemisphere & UE rehabilitation | Experimental | 10-minute active inhibitory HD-tES over the unaffected hemisphere's M1 followed by 10 minutes of sham excitatory HD-tES over the affected hemisphere's M1, combined with upper extremity rehabilitation of affected side. Receives: Device: HD-tES; Other: UE rehabilitation |
| Simultaneous bilateral stimulation & UE rehabilitation | Experimental | Combined with upper extremity rehabilitation of affected side. Receives: Device: HD-tES; Device: HD-tES (Bilateral) |
| Sham stimulation& UE rehabilitation | Sham comparator | The sham control group will receive sham HD-tCES combined with upper extremity rehabilitation of affected side. Receives: Device: Sham HD-tES; Other: UE rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre- and 1-month change in motor function of the upper limbs assessed by Fugl-Meyer Assessment of Upper Extremity (FMA-UE)
The FMA-UE assesses motor functioning of upper extremity. Each movement is estimated by a 3-point scale (0-1-2). The total score of the FMA-UE is 66, and a higher score indicates that the patient has better movement ability.
Measured: Baseline (within 3 days ahead to the 1st intervention session), after 2-week intervention (within 3 days after the last intervention session), follow up (1-month after post-test)
Pre- and 1-month change in motor function of the upper limbs assessed by Action Research Arm Test (ARAT)
ARAT consists of 19 items,including grasp (6 items), grip (6 items), pinch (6 items), and gross movement (3 items). Each item is scored on a scale of 0-1-2-3, where 0 indicates the complete inability to perform the movement, 1 indicates partial completion of the movement, 2 indicates independent completion of the movement but with excessive time or difficulty, and 3 indicates a movement pattern that is roughly normal. The total score ranges from 0 to 57, with higher scores indicating better upper limb functional ability.
Measured: Baseline (within 3 days ahead to the 1st intervention session), after 2-week intervention (within 3 days after the last intervention session), follow up (1-month after post-test)
Secondary outcomes (5)
Pre- and 1-month change in motor function of the upper limbs assessed by Modified Ashworth Scale (MAS)
The MAS is commonly used in clinical practice for grading spasticity. The MAS is rated on a 6-point scale (0, 1, 1+, 2, 3, 4), and a higher score indicates that the patient has higher muscle tension. The muscles being assessed include shoulder abductor, elbow flexor, elbow extensor, wrist flexor, and finger flexor.
Measured: Baseline (within 3 days ahead to the 1st intervention session), after 2-week intervention (within 3 days after the last intervention session), follow up (1-month after post-test)
Pre- and 1-month change in sensory function of the upper limbs assessed by Rivermead Assessment of Somatosensory Performance (RASP)
There are a total of 33 items, among which 5 items assess facial and upper and lower limb tactile discrimination, 5 items assess facial and upper and lower limb pressure sensation, 5 items assess facial and upper and lower limb tactile localization, 2 items assess facial and hand sensory extinction, 1 item assesses finger two-point discrimination, 5 items assess facial and upper and lower limb temperature sensation, 5 items assess upper and lower limb proprioception, and 5 items assess upper and lower limb kinesthesia. Each item is tested 6-9 times, and scores are calculated based on the number of correct responses, with higher scores indicating better somatosensory function.
Measured: Baseline (within 3 days ahead to the 1st intervention session), after 2-week intervention (within 3 days after the last intervention session), follow up (1-month after post-test)
Pre- and 1-month change in used and quality of affected extremity assessed by Motor Activity Log (MAL)
The questionnaire assesses the frequency and quality of use of the affected upper limb in daily activities for stroke or brain injury patients with hemiparesis. There are a total of 30 items representing common daily activities, with each item scored on a scale of 0-5. A score of 0 indicates no use of the affected side, while a score of 5 indicates the same frequency and quality of use as before the onset of the condition. The total score is calculated as the average score across the 30 items, with higher scores indicating better frequency of use or quality of movement of the affected upper limb.
Measured: Baseline (within 3 days ahead to the 1st intervention session), after 2-week intervention (within 3 days after the last intervention session), follow up (1-month after post-test)
Pre- and 1-month change in quality of life assessed by Stroke Impact Scale 3.0 (ML-SIS)
The ML-SIS questionnaire comprises 28 items designed to evaluate different aspects of stroke patients' quality of life. These aspects include muscle strength, memory, emotional status, communication ability, activities of daily living (ADL), mobility, hand function, and social participation. Each item within these categories is scored on a scale from 1 to 5, with higher scores indicating a better quality of life.This comprehensive assessment tool provides insights into various domains of stroke survivors' well-being.
Measured: Baseline (within 3 days ahead to the 1st intervention session), after 2-week intervention (within 3 days after the last intervention session), follow up (1-month after post-test)
Everytime report for the incidence of treatment-emergent adverse events [safety and tolerability]
Immediately after each HD-tES stimulation, the patient will be questioned about eventual side effect
Measured: Within 10 minutes after each intervention session (a total of 10 sessions, 5 sessions/week, lasting 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start15 Aug 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Nov 2027 (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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409143
- Sponsor's protocol ID
- 202309053DINB
- Status last verified
- Aug 2026
- First submitted
- 7 May 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms and Augmented Efficacy of High-definition Transcranial Electrical Stimulation on Upper-extremity Function in Patients With Subacute Stroke
- ClinicalTrials.gov ID
- NCT06409143
- Acronym / sponsor ID
- 202309053DINB
- Conditions
- Stroke
- Keywords
- Stroke, High-Definition Transcranial Electrical Stimulation, Upper-limb rehabilitation, Transcranial electrical stimulation, Neuroplasticity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 10 May 2024 (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.
Upper limb hemiparesis is the most common sequelae in patients, severely impacting their independence and quality of life. Transcranial electrical stimulation (tCES) is a non-invasive and safe treatment, which uses a low direct current or alternating current to change the excitability of the cerebral cortex. It can induces long-term potentiation-like or long-term depression-like effects, thereby modulating the cortical excitability. In recent years, researchers have developed high-definition (HD) devices, which integrate high definition ring electrode configurations and incorporate direct current with theta burst stimulation waveforms. Diverging from traditional transcranial direct current stimulation (tDCS), which applies weak currents (0.5-2 mA) through two large sponge electrodes (25~35 cm^2) externally to the scalp for widespread non-specific cortical stimulation, HD-tES employs an array of small-area electrodes (1 cm^2) to control current distribution over localized cortical regions, thereby enhancing spatial accuracy. However, there is a lack of studies validating the optimal waveform for HD-tES, as well as clinical evidence in subacute stroke populations. The optimal unilateral versus bilateral stimulation modes and their neurological mechanisms for stroke rehabilitation also remain uncertain.
Detailed description
This project comprises two sub-projects:
- Investigation of Neuromodulatory Effects of Stimulation Waveforms and Optimal Stimulation Waveform for Patients with Stroke : a crossover trial will compare the effects of seven high-definition transcranial electrical stimulation (HD-tES) waveforms on neural excitatory or inhibitory activity in healthy adults. These waveforms include three excitatory wave forms (anodal direct current (aDC), intermittent theta burst stimulation (iTBS), and a combination of aDC and iTBS (aDC+iTBS)) and three inhibitory wave forms (cathodal direct current (cDC), continuous theta burst stimulation (cTBS), and a combination of cDC and cTBS (cDC+cTBS)), along with a sham stimulation condition. Changes in cortical excitability over a 2-hour period before and after stimulation will be tracked. Validation of the optimal stimulation waveform for patients with stroke will be conducted through a crossover trial comparing three excitatory HD-tES waveforms for enhancing affected brain activity and three inhibitory HD-tES waveforms for reducing activity in the unaffected hemisphere. Changes in cortical excitability over a 2-hour period before and after stimulation will be monitored.
- Exploration of the Effects of Unilateral and Bilateral HD-tES in Patients with Subacute Stroke: A triple-blind randomized controlled trial will be conducted to compare four neuromodulatory modes combined with conventional upper limb rehabilitation on brain activity and upper limb function in patients with subacute stroke. These modes include excitatory stimulation on the affected hemisphere (based on results from sub-project one, choosing from aDC, iTBS, or aDC+iTBS), inhibitory stimulation on the unaffected hemisphere (based on results from sub-project one, choosing from cDC, cTBS, or cDC+cTBS), simultaneous bilateral stimulation, and sham stimulation.
The primary outcome will focus on upper limb functional activity and upper limb motor function, with other indicators serving as secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Excitatory stimulation on the affected hemisphere & UE rehabilitation | Experimental | Device: HD-tES, Other: UE rehabilitation10 minutes sham inhibitory HD-tES over the unaffected hemisphere's M1 followed by 10 minutes of excitatory HD-tES over the affected hemisphere's M1, combined with upper extremity rehabilitation of affected side. |
| Inhibitory stimulation on the unaffected hemisphere & UE rehabilitation | Experimental | Device: HD-tES, Other: UE rehabilitation10-minute active inhibitory HD-tES over the unaffected hemisphere's M1 followed by 10 minutes of sham excitatory HD-tES over the affected hemisphere's M1, combined with upper extremity rehabilitation of affected side. |
| Simultaneous bilateral stimulation & UE rehabilitation | Experimental | Device: HD-tES, Device: HD-tES (Bilateral)Combined with upper extremity rehabilitation of affected side. |
| Sham stimulation& UE rehabilitation | Sham comparator | Device: Sham HD-tES, Other: UE rehabilitationThe sham control group will receive sham HD-tCES combined with upper extremity rehabilitation of affected side. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Sub-Project 1 (Healthy)
- Adults aged 18 and above.
- Confirmed right-handedness using the Edinburgh Handedness Inventory.
- Sub-Project 1 (Post-stroke patients)
- Aged 18 and above.
Key exclusion criteria (36 listed)
- Sub-Project 1 (Healthy)
- History of neurological disorders (e.g., stroke, brain tumor, epilepsy), psychiatric disorders (e.g., substance abuse, major depression, schizophrenia, bipolar disorder), or musculoskeletal disorders of the upper limb.
- Contraindications to transcranial electrical stimulation, including history of epilepsy, atrial fibrillation, presence of metal implants, cardiac pacemakers, convexity skull defects, or increased intracranial pressure.
- Skin allergies, contact dermatitis, abnormal pain, hypersensitivity to pain, wounds, or ulcers on the head.
- Participation in other invasive or non-invasive brain stimulation research studies.
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 |
|---|---|---|
| HD-tESThe intensity of HD-tES is set at 2 mA, the current intensity ramps up to 2 mA within 5 seconds, remains at 2 mA for 10 minutes, and then ramps down to zero within 5 seconds. For the sham stimulation, the current intensity ramps up and down at the first and last 10 seconds, with the remaining 10 minutes set at 0 mA. The inhibitory and excitatory waveform will be selected based on results of sub-project 1. | Device | Excitatory stimulation on the affected hemisphere & UE rehabilitation, Inhibitory stimulation on the unaffected hemisphere & UE rehabilitation, Simultaneous bilateral stimulation & UE rehabilitation |
| Sham HD-tESThe intensity of HD-tES is set at 2 mA, the current intensity ramps up to 2 mA within 5 seconds, remains at 2 mA for 10 minutes, and then ramps down to zero within 5 seconds. For the sham stimulation, the current intensity ramps up and down at the first and last 10 seconds, with the remaining 10 minutes set at 0 mA. The inhibitory and excitatory waveform will be selected based on results of sub-project 1. | Device | Sham stimulation& UE rehabilitation |
| UE rehabilitationUpper extremity rehabilitation programs will be selected and graded in accordance with each patient's upper extremity function and specific aims of activities of daily living. Upper extremity rehabilitation will be provided for 60 minutes each time, 5 times a week, lasting for 3 weeks. | Other | Excitatory stimulation on the affected hemisphere & UE rehabilitation, Inhibitory stimulation on the unaffected hemisphere & UE rehabilitation, Sham stimulation& UE rehabilitation |
| HD-tES (Bilateral)The intensity of HD-tES is set at 2 mA, the current intensity ramps up to 2 mA within 5 seconds, remains at 2 mA for 10 minutes, and then ramps down to zero within 5 seconds. | Device | Simultaneous bilateral stimulation & UE rehabilitation |
Primary outcome
Pre- and 1-month change in motor function of the upper limbs assessed by Fugl-Meyer Assessment of Upper Extremity (FMA-UE)
Time frame: Baseline (within 3 days ahead to the 1st intervention session), after 2-week intervention (within 3 days after the last intervention session), follow up (1-month after post-test)
The FMA-UE assesses motor functioning of upper extremity. Each movement is estimated by a 3-point scale (0-1-2). The total score of the FMA-UE is 66, and a higher score indicates that the patient has better movement ability.
Pre- and 1-month change in motor function of the upper limbs assessed by Action Research Arm Test (ARAT)
Time frame: Baseline (within 3 days ahead to the 1st intervention session), after 2-week intervention (within 3 days after the last intervention session), follow up (1-month after post-test)
ARAT consists of 19 items,including grasp (6 items), grip (6 items), pinch (6 items), and gross movement (3 items). Each item is scored on a scale of 0-1-2-3, where 0 indicates the complete inability to perform the movement, 1 indicates partial completion of the movement, 2 indicates independent completion of the movement but with excessive time or difficulty, and 3 indicates a movement pattern that is roughly normal. The total score ranges from 0 to 57, with higher scores indicating better upper limb functional ability.
5 secondary outcomes
Pre- and 1-month change in motor function of the upper limbs assessed by Modified Ashworth Scale (MAS)
Time frame: Baseline (within 3 days ahead to the 1st intervention session), after 2-week intervention (within 3 days after the last intervention session), follow up (1-month after post-test)
Pre- and 1-month change in sensory function of the upper limbs assessed by Rivermead Assessment of Somatosensory Performance (RASP)
Time frame: Baseline (within 3 days ahead to the 1st intervention session), after 2-week intervention (within 3 days after the last intervention session), follow up (1-month after post-test)
Pre- and 1-month change in used and quality of affected extremity assessed by Motor Activity Log (MAL)
Time frame: Baseline (within 3 days ahead to the 1st intervention session), after 2-week intervention (within 3 days after the last intervention session), follow up (1-month after post-test)
Pre- and 1-month change in quality of life assessed by Stroke Impact Scale 3.0 (ML-SIS)
Time frame: Baseline (within 3 days ahead to the 1st intervention session), after 2-week intervention (within 3 days after the last intervention session), follow up (1-month after post-test)
Everytime report for the incidence of treatment-emergent adverse events [safety and tolerability]
Time frame: Within 10 minutes after each intervention session (a total of 10 sessions, 5 sessions/week, lasting 2 weeks)
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 20 Aug 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HD-tES, UE rehabilitation and HD-tES (Bilateral) in people with Stroke, run by National Taiwan University Hospital at 3 sites in Taiwan.
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 15 inclusion and 36 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 20 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 3 sites in Taiwan. 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?
Contact Mon-Ting Lin (+886-972-652-480, B96401093@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre- and 1-month change in motor function of the upper limbs assessed by Fugl-Meyer Assessment of Upper Extremity (FMA-UE) (time frame: Baseline (within 3 days ahead to the 1st intervention session), after 2-week intervention (within 3 days after the last intervention session), follow up (1-month after post-test)). 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?
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 20 Aug 2026.