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StrokeNCT04278105

High-definition Transcranial Electrical Stimulation for Upper Extremity Rehabilitation

A study testing HD-tCES and Upper extremity rehabilitation in people with Stroke, run by Taipei Medical University at 3 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Upper extremity rehabilitation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
3 sitesTaiwan
Study dates
1 Mar 2020to 12 Mar 2021
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.
  • Muscular inelasticity (spasticity) 1-3 on the affected upper limb, evaluated by the Modified Ashworth Scale.

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

3 sites in 1 country.

Taiwan3 sites

  • Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

    New Taipei City

  • Taipei Medical University Hospital

    Taipei, 110

  • Taipei Municipal Wanfang Hospital - Taipei Medical University

    Taipei

Other trials in Taiwan

About this study

Official title: Application of High-definition Transcranial Electrical Stimulation in the Upper Extremity Rehabilitation

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. Therefore, we aim to develop a wearable tCES with high definition and special waveforms in this study. This novel stimulation system will result in more precise and focal stimulation of selected brain regions with special waveforms to display better neuromodulation performance. We expect that the novel high-definition tCES (HD-tCES) combined with the upper 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, Upper extremity rehabilitation
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.

  • HD-tCESDevice

    The positions of the lesion side primary motor cortex were defined as C3/C4 according to the international 10-20 system of electroencephalograms. 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 positions of the lesion side primary motor cortex were defined as C3/C4 according to the international 10-20 system of electroencephalograms. 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.

  • Upper extremity 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 30 minutes each time, 3 times a week, lasting for 4 weeks.

Study groups in NCT04278105
Study groupRoleWhat they receive
HD-tCES & upper extremity rehabilitationExperimentalThe experiment group will receive HD-tCES combined with upper extremity rehabilitation of affected side.
Receives: Device: HD-tCES; Other: Upper extremity rehabilitation
Sham HD-tCES & upper extremity rehabilitationSham comparatorThe sham control group will receive sham HD-tCES combined with upper extremity rehabilitation of affected side.
Receives: Device: Sham HD-tCES; Other: Upper extremity rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in the Fugl-Meyer Assessment upper extremity scale (FMA-UE) after intervention

    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 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)

Secondary outcomes (5)

  1. Change from baseline in the Wolf Motor Function Test (WMFT) after intervention

    The WMFT assesses upper extremity motor ability through timed and functional tasks. The items are rated on a 6-point scale (0-1-2-3-4-5). The total score of the WMFT is 75, with higher scores indicating higher functioning levels.

    Measured: Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)

  2. 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 4-week intervention (within 7 days after the last intervention session)

  3. 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 shoulder abductor, elbow flexor, elbow extensor, wrist flexor, and finger flexor.

    Measured: Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)

  4. 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 20-second period will be recorded.

    Measured: Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)

  5. Incidence of treatment-emergent adverse events [safety and tolerability]

    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.

  1. First posted20 Feb 2020
  2. Study start1 Mar 2020
  3. Primary completion12 Mar 2021
  4. Study completion12 Mar 2021

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04278105
Sponsor's protocol ID
N201909051
Other IDs
MOST-108-2321-B-038-002
Status last verified
Mar 2021
First submitted
18 Feb 2020
Last updated
1 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Huang YJ, Wang SM, Chen C, Chen CA, Wu CW, Chen JJ, Peng CW, Lin CW, Huang SW, Chen SC. High-Definition Transcranial Direct Current with Electrical Theta Burst on Post-Stroke Motor Rehabilitation: A Pilot Randomized Controlled Trial. Neurorehabil Neural Repair. 2022 Sep;36(9):645-654. doi: 10.1177/15459683221121751. Epub 2022 Sep 1.

    PubMed 36047662

  • Wang SS, Huang YJ, Chen JJ, Wu CW, Chen CA, Lin CW, Nguyen VT, Peng CW. Designing and pilot testing a novel high-definition transcranial burst electrostimulation device for neurorehabilitation. J Neural Eng. 2021 Sep 17;18(5). doi: 10.1088/1741-2552/ac23be.

    PubMed 34479230

Questions about this trial

What is this clinical trial studying?

A study testing HD-tCES and Upper extremity rehabilitation in people with Stroke, run by Taipei Medical University 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 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 1 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 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?

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 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?

On the ClinicalTrials.gov record for NCT04278105, which also lists 2 linked publications.

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 1 Apr 2021.

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