StrokeNCT04515121
High-definition Transcranial Electrical Stimulation for Lower Limb Stroke Rehabilitation
A study testing HD-tCES and Lower limb rehabilitation in people with Stroke, run by Taipei Medical University Hospital at 3 sites in Taiwan.
Trial summary
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 20 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- HD-tCES and Lower limb rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 3 sitesTaiwan
- Study dates
- 20 Aug 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With a diagnosis of stroke.
- Age ≥ 20 years.
- Hemiplegia, Brunnstrom stage III-V.
- 6 months to 5 years after stroke.
- Muscular inelasticity (spasticity) 1-3 on the affected lower limb, evaluated by the Modified Ashworth Scale.
- Ability to walk for 10 min non-stop with no gait aids or ability to walk 20 m with supervision or slight assistance.
Who cannot join
- Intolerance to electrical stimulation.
- Contracture on lower extremities, and limitation in joint range of motion.
- Severe spasticity.
- Ossification or inflammation in muscle tissue.
- A history of arrhythmia.
- Implantable medical electronic devices (e.g., like pacemaker).
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- Metal implants in the head or neck.
- Wounds on the skin of head.
- A history of brain surgery or severe brain trauma.
- Severe cognitive or psychiatric disorders (e.g., schizophrenia, depression or bipolar disorder).
- A history of seizure or other brain pathology.
- Drug or alcohol abuse.
- Malignant neoplasm or rheumatism disorder (e.g., SLE, RA, AS, IBD)
- Undergoing other non-invasive brain stimulation.
- Intra-cerebral lesions (such as brain tumors, arteriovenous tumors).
- History of encephalitis or meningitis.
- Stroke lesion in cerebellum or brainstem.
- Leg amputation.
- Sleep deprivation.
- Severe or recent heart disease.
- Subjects who use drugs that may lower the seizure threshold.
- Pregnant or breastfeeding women.
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites, 3 recruiting
- Recruiting
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, 235
Hung-Chou Chen, MD, +886-970-747-158, b8601084@tmu.edu.tw
Hung-Chou Chen, MD
- Recruiting
Taipei Medical University Hospital
Taipei, 110
Chien-Hung Lai, PhD, +886-2-27372181 ext. 1236, chlai@tmu.edu.tw
Chien-Hung Lai, PhD
- Recruiting
Taipei Municipal Wanfang Hospital - Taipei Medical University
Taipei, 116
Kwang-Hwa Chang, MS, +886-970-746-881, chang2773@gmail.com
Kwang-Hwa Chang, MS
About this study
Official title: Effects of High-definition Transcranial Electrical Stimulation on the Lower Extremity in Patients With Stroke
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. The tCES has been applied in clinical trials related to rehabilitation research in recent years, and the safety and effectiveness have also been established. However, the existing tCES products effect on the whole brain networks and lack special waveforms. We developed a wearable high-definition tCES (HD-tCES) with special waveforms. This novel stimulation system will result in more precise and focal stimulation of selected brain regions with special waveforms to display better neuromodulation performance. In this study, we will preliminarily examine the effects and safety of the HD-tCES on lower extremity in patients with stroke. We expect that the HD-tCES combined with the lower extremity rehabilitation can shorten the duration of rehabilitative periods, improve stroke patients' activity of daily living, reduce the care burden of patients' family, and subsequently decrease the cost of health care insurance.
- Conditions
- Stroke
- Being tested
- HD-tCES, Sham HD-tCES, Lower limb rehabilitation
- Keywords
- Stroke, Transcranial electrical stimulation, Lower-limb rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD-tCESDevice
The high definition transcranial electrical stimulation was applied using a 1*4 ring electrode configuration. The anodal electrode was placed on the ipsilesional C1/C2, and the remaining 4 cathodal electrodes were placed in a radius of approximately 7.5 cm from anode (Cz, F3, T7, and P3 on the left hemisphere or Cz, F4, T8, and P4 on the right hemisphere). HD-tCES will be applied for 20 minutes at an intensity of 1.0 mA direct current stimulation and a specific-added waveform each time, 3 times a week, lasting for 4 weeks.
Sham HD-tCESDevice
The high definition transcranial electrical stimulation was applied using a 1*4 ring electrode configuration. The anodal electrode was placed on the ipsilesional C1/C2, and the remaining 4 cathodal electrodes were placed in a radius of approximately 7.5 cm from anode (Cz, F3, T7, and P3 on the left hemisphere or Cz, F4, T8, and P4 on the right hemisphere). Sham HD-tCES will consist of a 5-second ramp up to 1.0 mA direct current stimulation and a specific-added waveform followed immediately by a 5-second ramp down, no current in the middle 19 minutes 40 seconds, and a ramp-up and ramp-down period during the last 10 seconds.
Lower limb rehabilitationOther
Lower limb rehabilitation programs will be selected and graded in accordance with each patient's lower limb function and specific aims of activities of daily living. Lower limb rehabilitation will be provided for 30 minutes each time, 3 times a week, lasting for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HD-tCES & lower limb rehabilitation | Experimental | The experiment group will receive HD-tCES combined with lower limb rehabilitation of affected side. Receives: Device: HD-tCES; Other: Lower limb rehabilitation |
| Sham HD-tCES & lower limb rehabilitation | Sham comparator | The sham control group will receive sham HD-tCES combined with lower limb rehabilitation of affected side. Receives: Device: Sham HD-tCES; Other: Lower limb rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Fugl-Meyer Assessment lower extremity scale (FMA-LE) after intervention
The FMA-LE assesses motor functioning of lower extremity. Each movement is estimated by a 3-point scale (0-1-2). The total score of the FMA-LE is 34, and a higher score indicates that the patient has better movement ability.
Measured: Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Secondary outcomes (6)
Change from baseline in the Berg Balance Scale (BBS) after intervention
The BBS is used to objectively determine a patient's ability to safely balance during a series of predetermined tasks. It contains 14 items with each item consisting of a five-point ordinal scale ranging from 0 to 4. A higher score indicates that the patient has better balance.
Measured: Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Change from baseline in the Timed Up and Go Test (TUG) after intervention
The TUG assesses a patient's mobility and requires both static and dynamic balance. It measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Measured: Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Change from baseline in the Gait Evaluation after intervention
The Gait Evaluation includes cadence, stride duration, stride length, and velocity.
Measured: Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Change from baseline in the Modified Ashworth Scale (MAS) after intervention
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 hip flexor, hip extensor, knee flexor, knee extensor, ankle dorsiflexor, and ankle plantarflexor.
Measured: Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Change from baseline motor evoked potential (MEP) after intervention
The MEP elicited in peripheral muscles by transcranial magnetic stimulation over motor cortex is one of the hallmark measures for non-invasive quantification of cortical excitability.
Measured: Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Incidence of treatment-emergent adverse events
Immediately after each HD-tCES stimulation, the patient will be questioned about eventual side effect.
Measured: Within 10 minutes after each intervention session (a total of 12 sessions, 3 sessions/week, lasting 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start20 Aug 2020
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai chien hung, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515121
- Sponsor's protocol ID
- N202004091
- Status last verified
- Jan 2023
- First submitted
- 13 Aug 2020
- Last updated
- 31 Jan 2023
- 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 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-definition Transcranial Electrical Stimulation on the Lower Extremity in Patients With Stroke
- ClinicalTrials.gov ID
- NCT04515121
- Acronym / sponsor ID
- N202004091
- Conditions
- Stroke
- Keywords
- Stroke, Transcranial electrical stimulation, Lower-limb rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Aug 2020 (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.
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. The tCES has been applied in clinical trials related to rehabilitation research in recent years, and the safety and effectiveness have also been established. However, the existing tCES products effect on the whole brain networks and lack special waveforms. We developed a wearable high-definition tCES (HD-tCES) with special waveforms. This novel stimulation system will result in more precise and focal stimulation of selected brain regions with special waveforms to display better neuromodulation performance. In this study, we will preliminarily examine the effects and safety of the HD-tCES on lower extremity in patients with stroke. We expect that the HD-tCES combined with the lower extremity rehabilitation can shorten the duration of rehabilitative periods, improve stroke patients' activity of daily living, reduce the care burden of patients' family, and subsequently decrease the cost of health care insurance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HD-tCES & lower limb rehabilitation | Experimental | Device: HD-tCES, Other: Lower limb rehabilitationThe experiment group will receive HD-tCES combined with lower limb rehabilitation of affected side. |
| Sham HD-tCES & lower limb rehabilitation | Sham comparator | Device: Sham HD-tCES, Other: Lower limb rehabilitationThe sham control group will receive sham HD-tCES combined with lower limb rehabilitation of affected side. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- With a diagnosis of stroke.
- Age ≥ 20 years.
- Hemiplegia, Brunnstrom stage III-V.
- 6 months to 5 years after stroke.
- Muscular inelasticity (spasticity) 1-3 on the affected lower limb, evaluated by the Modified Ashworth Scale.
Key exclusion criteria (22 listed)
- Intolerance to electrical stimulation.
- Contracture on lower extremities, and limitation in joint range of motion.
- Severe spasticity.
- Ossification or inflammation in muscle tissue.
- A history of arrhythmia.
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-tCESThe high definition transcranial electrical stimulation was applied using a 1*4 ring electrode configuration. The anodal electrode was placed on the ipsilesional C1/C2, and the remaining 4 cathodal electrodes were placed in a radius of approximately 7.5 cm from anode (Cz, F3, T7, and P3 on the left hemisphere or Cz, F4, T8, and P4 on the right hemisphere). HD-tCES will be applied for 20 minutes at an intensity of 1.0 mA direct current stimulation and a specific-added waveform each time, 3 times a week, lasting for 4 weeks. | Device | HD-tCES & lower limb rehabilitation |
| Sham HD-tCESThe high definition transcranial electrical stimulation was applied using a 1*4 ring electrode configuration. The anodal electrode was placed on the ipsilesional C1/C2, and the remaining 4 cathodal electrodes were placed in a radius of approximately 7.5 cm from anode (Cz, F3, T7, and P3 on the left hemisphere or Cz, F4, T8, and P4 on the right hemisphere). Sham HD-tCES will consist of a 5-second ramp up to 1.0 mA direct current stimulation and a specific-added waveform followed immediately by a 5-second ramp down, no current in the middle 19 minutes 40 seconds, and a ramp-up and ramp-down period during the last 10 seconds. | Device | Sham HD-tCES & lower limb rehabilitation |
| Lower limb rehabilitationLower limb rehabilitation programs will be selected and graded in accordance with each patient's lower limb function and specific aims of activities of daily living. Lower limb rehabilitation will be provided for 30 minutes each time, 3 times a week, lasting for 4 weeks. | Other | HD-tCES & lower limb rehabilitation, Sham HD-tCES & lower limb rehabilitation |
Primary outcome
Change from baseline in the Fugl-Meyer Assessment lower extremity scale (FMA-LE) after intervention
Time frame: Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
The FMA-LE assesses motor functioning of lower extremity. Each movement is estimated by a 3-point scale (0-1-2). The total score of the FMA-LE is 34, and a higher score indicates that the patient has better movement ability.
6 secondary outcomes
Change from baseline in the Berg Balance Scale (BBS) after intervention
Time frame: Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Change from baseline in the Timed Up and Go Test (TUG) after intervention
Time frame: Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Change from baseline in the Gait Evaluation after intervention
Time frame: Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Change from baseline in the Modified Ashworth Scale (MAS) after intervention
Time frame: Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Change from baseline motor evoked potential (MEP) after intervention
Time frame: Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Incidence of treatment-emergent adverse events
Time frame: Within 10 minutes after each intervention session (a total of 12 sessions, 3 sessions/week, lasting 4 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- 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. This study is not recruiting at the moment.
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-tCES and Lower limb rehabilitation in people with Stroke, run by Taipei Medical 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 6 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 31 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chien-Hung Lai, PhD (+886-2-27372181 ext. 1236, chlai@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Fugl-Meyer Assessment lower extremity scale (FMA-LE) after intervention (time frame: Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)). 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 31 Jan 2023.