StrokeNCT04369235
Transcranial Electrical Stimulation With Special Waveform for Upper Extremity Rehabilitation for Patients With Stroke
A study testing tCES in people with Stroke, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Transcranial electrical stimulation (tCES) is contemporarily important issues in the advanced rehabilitation medicine. tCES can selectively change the excitability of regional cortex with non-invansive and safety properties. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- tCES
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Mar 2017to 30 Apr 2020
- 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
- Age ≥ 20 years.
- Unilateral cerebral stroke with hemiplegia in Brunnstrom stage III-V.
- 6 months to 5 years after stroke.
- Adequate understanding of verbal/written information and physically able to complete the motor learning of functional tasks with the affected hand.
Who cannot join
- Extremely sensitive to electrical stimulation and cannot tolerate it.
- Contracture on upper extremities, and limitation in joint range of motion.
- The muscle tone was severe spasticity.
- Ossification or inflammation in muscle tissue.
- A history of cardiopulmonary disease or arrhythmia.
- With implantable medical electronic devices, like pacemaker.
Show all 13Show fewer
- Pressure sores or wounds on the skin of head and upper extremities.
- Metal implants in the head (neck).
- Severe cognitive or psychiatric disorders, such as schizophrenia or dissociative identity disorder.
- A history of seizure or other brain pathology.
- Brain surgery or severe brain trauma.
- Drug or alcohol abuse.
- Malignant neoplasm or rheumatism disorder, like SLE, RA, or AS.
Trial locations and contacts
1 site in 1 country.
About this study
Transcranial electrical stimulation (tCES) is contemporarily important issues in the advanced rehabilitation medicine. tCES can selectively change the excitability of regional cortex with non-invansive and safety properties. Therefore, the investigators aim to develop a set of tCES system with special waveforms for using in clinical rehabilitation of upper extremities. This developed tCES system is smaller than all commercial available products, which could be conveniently and portably wore on head for clinical rehabilitation. In addition, the present tCES system with special waveforms developing by the investigators is much more efficient on improving neuroplasticity than the traditional transcranial direct current stimulation (tDCS) in rats. The investigators hope the tCES system combined with the rehabilitation of body extremities will become a routine treatment for stroke patients at hospitals or residential rehabilitation in the future.
Read the detailed description
Transcranial direct current stimulation (tDCS) and intermittent theta burst stimulation (iTBS) were both demonstrated to have therapeutic potentials to rapidly induce neuroplastic effects in various rehabilitation training regimens. Recently, the investigators have developed a novel transcranial electrostimulation device that can flexibly output an electrical current with combined tDCS and iTBS waveforms. However, limited studies have determined the therapeutic effects of this special waveform combination on clinical rehabilitation. Herein, the investigators aiming to brain stimulation effects of tDCS-iTBS on upper-limb motor function in chronic stroke patients.
Twenty-four subjects with a chronic stroke were randomly assigned to a real non-invasive brain stimulation (NIBS; subjects received the real tDCS+iTBS output) group or a sham NIBS (subjects received sham tDCS+iTBS output) group. All subjects underwent 1 h treatment of a conventional rehabilitation program (3 days a week for 6 weeks), where a 20-min NIBS intervention was simultaneously applied during conventional rehabilitation. Outcome measures were assessed before and immediately after the intervention period: Fugl-Meyer Assessment-Upper Extremity (FMA-UE), Jebsen-Taylor Hand Function Test (JTT), and Finger-to-Nose Test (FNT).
- Conditions
- Stroke
- Being tested
- tCES, Sham tCES
- Keywords
- Stroke, Transcranial electrical stimulation, Upper-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.
tCESDevice
The positions of the lesion side primary motor cortex were defined as C3/C4 according to the international 10-20 system of electroencephalograms. tCES will be applied for 20 minutes at an intensity of 1.0 -1.5 mA direct current stimulation and a specific-added waveform each time, 3 times a week, lasting for 6 weeks.
Sham tCESDevice
The positions of the lesion side primary motor cortex were defined as C3/C4 according to the international 10-20 system of electroencephalograms. Sham tCES will consist of a 5-second ramp up to 1.0-1.5 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.
| Study group | Role | What they receive |
|---|---|---|
| tCES & upper extremity rehabilitation | Experimental | The experiment group will receive tCES combined with upper extremity rehabilitation of affected side. Receives: Device: tCES |
| Sham tCES & upper extremity rehabilitation | Sham comparator | The sham control group will receive sham tCES combined with upper extremity rehabilitation of affected side. Receives: Device: Sham tCES |
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 upper extremity scale (FMA-UE) after intervention
The FMA-UE was performed (score ranges from 0 to 66) to assess upper limb motor recovery. 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 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
Secondary outcomes (3)
Change from baseline in the Jebsen-Taylor Hand Function Test (JTT) after intervention
The JTT assesses hand functions commonly used in activities of daily living. The subtests are scored according to time taken to complete the task. Total score is the sum of time taken for each subtest, with shorter times indicating better performance.
Measured: Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
Change from baseline in the Finger to Nose Test after intervention
The Finger to Nose Test assesses coordination of upper-extremity movement. The number of complete nose-target movements during a 1 min period will be recorded.
Measured: Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
Modified Ashworth scale (MAS) measures
The Modified Ashworth scale (MAS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity
Measured: Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start2 Mar 2017
- Primary completion31 Jan 2020
- Study completion30 Apr 2020
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.
- More trials run by Taipei Medical UniversityThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- Chi-Wei Peng, Ph.D., Principal investigator, School of Biomedical Engineering, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369235
- Sponsor's protocol ID
- N201702070
- Status last verified
- Apr 2020
- First submitted
- 27 Apr 2020
- Last updated
- 15 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen SC, Yang LY, Adeel M, Lai CH, Peng CW. Transcranial electrostimulation with special waveforms enhances upper-limb motor function in patients with chronic stroke: a pilot randomized controlled trial. J Neuroeng Rehabil. 2021 Jun 30;18(1):106. doi: 10.1186/s12984-021-00901-8.
PubMed 34193179
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Electrical Stimulation With Special Waveform for Upper Extremity Rehabilitation for Patients With Stroke
- ClinicalTrials.gov ID
- NCT04369235
- Acronym / sponsor ID
- N201702070
- Conditions
- Stroke
- Keywords
- Stroke, Transcranial electrical stimulation, Upper-limb rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 30 Apr 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 contemporarily important issues in the advanced rehabilitation medicine. tCES can selectively change the excitability of regional cortex with non-invansive and safety properties. Therefore, the investigators aim to develop a set of tCES system with special waveforms for using in clinical rehabilitation of upper extremities. This developed tCES system is smaller than all commercial available products, which could be conveniently and portably wore on head for clinical rehabilitation. In addition, the present tCES system with special waveforms developing by the investigators is much more efficient on improving neuroplasticity than the traditional transcranial direct current stimulation (tDCS) in rats. The investigators hope the tCES system combined with the rehabilitation of body extremities will become a routine treatment for stroke patients at hospitals or residential rehabilitation in the future.
Detailed description
Transcranial direct current stimulation (tDCS) and intermittent theta burst stimulation (iTBS) were both demonstrated to have therapeutic potentials to rapidly induce neuroplastic effects in various rehabilitation training regimens. Recently, the investigators have developed a novel transcranial electrostimulation device that can flexibly output an electrical current with combined tDCS and iTBS waveforms. However, limited studies have determined the therapeutic effects of this special waveform combination on clinical rehabilitation. Herein, the investigators aiming to brain stimulation effects of tDCS-iTBS on upper-limb motor function in chronic stroke patients.
Twenty-four subjects with a chronic stroke were randomly assigned to a real non-invasive brain stimulation (NIBS; subjects received the real tDCS+iTBS output) group or a sham NIBS (subjects received sham tDCS+iTBS output) group. All subjects underwent 1 h treatment of a conventional rehabilitation program (3 days a week for 6 weeks), where a 20-min NIBS intervention was simultaneously applied during conventional rehabilitation. Outcome measures were assessed before and immediately after the intervention period: Fugl-Meyer Assessment-Upper Extremity (FMA-UE), Jebsen-Taylor Hand Function Test (JTT), and Finger-to-Nose Test (FNT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tCES & upper extremity rehabilitation | Experimental | Device: tCESThe experiment group will receive tCES combined with upper extremity rehabilitation of affected side. |
| Sham tCES & upper extremity rehabilitation | Sham comparator | Device: Sham tCESThe sham control group will receive sham tCES combined with upper extremity 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 (4 listed)
- Age ≥ 20 years.
- Unilateral cerebral stroke with hemiplegia in Brunnstrom stage III-V.
- 6 months to 5 years after stroke.
- Adequate understanding of verbal/written information and physically able to complete the motor learning of functional tasks with the affected hand.
Key exclusion criteria (13 listed)
- Extremely sensitive to electrical stimulation and cannot tolerate it.
- Contracture on upper extremities, and limitation in joint range of motion.
- The muscle tone was severe spasticity.
- Ossification or inflammation in muscle tissue.
- A history of cardiopulmonary disease or 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 |
|---|---|---|
| tCESThe positions of the lesion side primary motor cortex were defined as C3/C4 according to the international 10-20 system of electroencephalograms. tCES will be applied for 20 minutes at an intensity of 1.0 -1.5 mA direct current stimulation and a specific-added waveform each time, 3 times a week, lasting for 6 weeks. | Device | tCES & upper extremity rehabilitation |
| Sham tCESThe positions of the lesion side primary motor cortex were defined as C3/C4 according to the international 10-20 system of electroencephalograms. Sham tCES will consist of a 5-second ramp up to 1.0-1.5 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 tCES & upper extremity rehabilitation |
Primary outcome
Change from baseline in the Fugl-Meyer Assessment upper extremity scale (FMA-UE) after intervention
Time frame: Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
The FMA-UE was performed (score ranges from 0 to 66) to assess upper limb motor recovery. 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.
3 secondary outcomes
Change from baseline in the Jebsen-Taylor Hand Function Test (JTT) after intervention
Time frame: Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
Change from baseline in the Finger to Nose Test after intervention
Time frame: Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
Modified Ashworth scale (MAS) measures
Time frame: Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Derived from this study: PubMed 34193179Chen SC, Yang LY, Adeel M, Lai CH, Peng CW. Transcranial electrostimulation with special waveforms enhances upper-limb motor function in patients with chronic stroke: a pilot randomized controlled trial. J Neuroeng Rehabil. 2021 Jun 30;18(1):106. doi: 10.1186/s12984-021-00901-8.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Chi-Wei Peng, Ph.D. principal investigator
School of Biomedical Engineering, Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tCES in people with Stroke, run by Taipei Medical University at 1 site 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 15 Apr 2021. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in the Fugl-Meyer Assessment upper extremity scale (FMA-UE) after intervention (time frame: Baseline (within 7 days ahead to the 1st intervention session) and after 6-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?
On the ClinicalTrials.gov record for NCT04369235, 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 15 Apr 2021.