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Transcranial Electrical Stimulation With Special Waveform for Upper Extremity Rehabilitation for Patients With Stroke

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ClinicalTrials.gov Identifier: NCT04369235
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : May 1, 2020
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
Taipei Medical University

Brief 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. 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 our team 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.

Condition or disease Intervention/treatment Phase
Stroke Device: tCES Device: Sham tCES Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Transcranial Electrical Stimulation With Special Waveform for Upper Extremity Rehabilitation for Patients With Stroke
Actual Study Start Date : March 2, 2017
Actual Primary Completion Date : January 31, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: tCES & upper extremity rehabilitation
The experiment group will receive tCES combined with upper extremity rehabilitation of affected side.
Device: tCES
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 Comparator: Sham tCES & upper extremity rehabilitation
The sham control group will receive sham tCES combined with upper extremity rehabilitation of affected side.
Device: Sham tCES
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    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.

  3. 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) ]
    The Modified Ashworth scale (MAS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 20 years.
  2. Unilateral cerebral stroke with hemiplegia in Brunnstrom stage III-V.
  3. 6 months to 5 years after stroke.
  4. Adequate understanding of verbal/written information and physically able to complete the motor learning of functional tasks with the affected hand.

Exclusion Criteria:

  1. Extremely sensitive to electrical stimulation and cannot tolerate it.
  2. Contracture on upper extremities, and limitation in joint range of motion.
  3. The muscle tone was severe spasticity.
  4. Ossification or inflammation in muscle tissue.
  5. A history of cardiopulmonary disease or arrhythmia.
  6. With implantable medical electronic devices, like pacemaker.
  7. Pressure sores or wounds on the skin of head and upper extremities.
  8. Metal implants in the head (neck).
  9. Severe cognitive or psychiatric disorders, such as schizophrenia or dissociative identity disorder.
  10. A history of seizure or other brain pathology.
  11. Brain surgery or severe brain trauma.
  12. Drug or alcohol abuse.
  13. Malignant neoplasm or rheumatism disorder, like SLE, RA, or AS.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369235


Contacts
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Contact: Chi-Wei Peng, Ph.D. +886-2-27361661 ext 3070 cwpeng@tmu.edu.tw

Locations
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Taiwan
Taipei Medical University Recruiting
Taipei city, Taiwan
Sponsors and Collaborators
Taipei Medical University
Ministry of Science and Technology, Taiwan
Investigators
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Principal Investigator: Chi-Wei Peng, Ph.D. School of Biomedical Engineering, Taipei Medical University
  Study Documents (Full-Text)

Documents provided by Taipei Medical University:
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Responsible Party: Taipei Medical University
ClinicalTrials.gov Identifier: NCT04369235    
Other Study ID Numbers: N201702070
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Medical University:
Stroke
Transcranial electrical stimulation
Upper-limb rehabilitation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases