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

NCT04369235 | Completed

• 1 other identifier: N201702070
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Stroke

Keywords

Stroke; Transcranial electrical stimulation; Upper-limb rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)

Study Arms (2)

tCES & upper extremity rehabilitation

EXPERIMENTAL

The experiment group will receive tCES combined with upper extremity rehabilitation of affected side.

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.

Device: Sham tCES

Interventions

tCES DEVICE

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.

tCES & upper extremity rehabilitation

Sham tCES DEVICE

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.

Sham tCES & upper extremity rehabilitation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 20 years.
• Unilateral cerebral stroke with hemiplegia in Brunnstrom stage III-V.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Taipei Medical University: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Taipei Medical University

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 34193179 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chi-Wei Peng, Ph.D.

  School of Biomedical Engineering, Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: March 2, 2017
• Primary Completion: January 31, 2020
• Study Completion: April 30, 2020
• Last Updated: April 15, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)