Augmenting the Effects of Mirror Therapy for Stroke Rehabilitation by tDCS

NCT04655209 | Unknown

• 1 other identifier: 201600227A0
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

This project is to evaluate and compare the impact of tDCS stimulation location on augmenting MT effects.

Conditions

Cerebrovascular Accident

Keywords

Mirror therapy; stroke

Outcome Measures

Primary Outcomes (2)

• EEG Physiological Assessments

  A wireless EEG device will be used to evaluate treatment-induced changes on cortical activity by ERD of mu rhythm EEG during the movements for reaching for pressing the desk button. The mu rhythm is a specific frequency range (8-12 Hz) in the EEG signal and the amplitude decrease in mu-rhythm power (called ERD) can be used to depict the temporal pattern of cortical activity when preparing, producing, and controlling movement events. The averaged area of the entire ERD curve under the reference level will be used as the amplitude parameter of cerebral activation. To characterize the ERD difference between the affected hemisphere and the unaffected hemisphere, a lateralization index (LI) will be used: LI = (ERDR- ERDL)/(ERDL+ERDR), where ERDR and ERDL represent the overall ERD areas (cerebral activation) of the C4 and C3 (or F4 and F3) channels. Significant increase of ERD in the damaged hemisphere and increase of LI will be indicators for a good recovery.

  baseline, posttest (1 month)

• Kinematic Protocols

  The movement of the markers will be captured with a 7-camera motion analysis system. The reaching movements will be recorded at a frequency of 120 Hz, and low-pass filtered at 5 Hz using a 2nd-order Butterworth filter with dual-passes. The kinematic variables for data analysis will include reaction time(RT), movement time(MT), peak velocity(PV), the percentage of MT where peak velocity occurs(PPV), movement units(MU), and maximum grip aperture(MGA). MGA is obtained only during the reach-to-grasp tasks. Less RT and MT suggest better movement efficiency, while higher amplitude of PPV indicates a more preplanned movement. A fewer number of MUs would suggest a smoother movement induced by the treatment. Larger MGA indicates a better, skilled strategy. Larger changes in the angles of shoulder, elbow, and wrist will indicate a better movement, while smaller angular changes and movement distance of the trunk will represent less trunk compensatory movement.

  baseline, posttest (1 month)

Secondary Outcomes (20)

• Change scores of Fugl-Meyer Assessment (FMA)

  baseline, posttest (1 month), follow-up (up to 3 months), follow-up (up to 6 months)

• Change scores of Modified Ashworth Scale (MAS)

  baseline, posttest (1 month)

• Change scores of Wolf Motor Function Test (WMFT)

  baseline, posttest (1 month)

• Change scores of The Chedoke Arm and Hand Activity Inventory (CAHAI)

  baseline, posttest (1 month)

• Change scores of Motor Activity Log (MAL)

  baseline, posttest (1 month), follow-up (up to 3 months), follow-up (up to 6 months)

Study Arms (3)

M1-Seq group

EXPERIMENTAL

Behavioral: apply a-tDCS on the ipsilesional M1 followed by MT (M1-Seq)

PMC-Seq group

EXPERIMENTAL

Behavioral: apply a-tDCS on the ipsilesional PMC followed by MT (PMC-Seq)

MT with sham tDCS

SHAM COMPARATOR

Behavioral: MT only with sham tDCS (MT)

Interventions

apply a-tDCS on the ipsilesional M1 followed by MT (M1-Seq) BEHAVIORAL

The participants in the M1-Seq group will first receive a-tDCS over ipsi-lesional M1 without any active arm practice for 20 minutes. For the next 20 minutes, the participants will start the MT, while the electrodes will be remained on the scalp with the stimulator off (sham tDCS condition). Then the electrodes will be removed, and the participants will receive additional 20 minutes of MT without tDCS followed by 30 minutes of functional task practice.

M1-Seq group

apply a-tDCS on the ipsilesional PMC followed by MT (PMC-Seq) BEHAVIORAL

The procedures for the PMC-Seq group will be the same as the M1-Seq, except that a-tDCS will be applied on ipsilesional PMC but not M1.

PMC-Seq group

MT only with sham tDCS (MT) BEHAVIORAL

For the MT group, the procedure will be the same as the other groups except that sham tDCS will be used for the first 40 minutes.

MT with sham tDCS

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• sustained an unilateral stroke with onset ≥ 6 months;
• UE-FMA score between 18 and 56 indicating moderate to mild motor severity;
• aged from 45 to 85 years old; and
• able to follow instructions and perform the tasks (Mini Mental State Examination ≥ 24).

You may not qualify if:

• if they
• have excessive spasticity or joint contracture of the paretic UE;
• are enrolled in other rehabilitation experiments or drug studies;
• have additional neurological or psychological disorders other than stroke;
• have received Botulinum toxin injections 3 months before enrollment;
• have unstable cardiovascular status such as uncontrolled hypertension or New York Heart Association (NYHA) Class III/IV heart failure;
• have contradictions to tDCS including a history of epilepsy, migraine headache, uncontrolled medical status, being pregnant, having a pacemaker, or metal implanted in their head or body; and
• have a history of drug or alcohol abuse, skin lesions on the electrode sites, brain tumor, brain injury, arteriovenous malformation (AVM), had brain surgery, other brain diseases (such as intracranial hypertension or cerebral edema), or being not suitable for using tDCS by the physician's assessment.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (2)

Taipei Tzu Chi Hospital

Xindian District, New Taipei City, 231, Taiwan

RECRUITING

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

Related Publications (1)

• Liao WW, Lin CY, Horng YS, Chen CL, Lee TH, Wu CY. Transcranial direct current stimulation over the motor and premotor cortex with mirror therapy improves motor control, muscle function, and brain activity in chronic stroke: a double-blind randomized sham-controlled trial. J Neuroeng Rehabil. 2025 Apr 26;22(1):98. doi: 10.1186/s12984-025-01635-7.

  PMID: 40287756 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

• Ching-Yi Wu

  Chang Gung University

  STUDY CHAIR

Central Study Contacts

Ching-Yi Wu, ScD

CONTACT

886-3-2118800; cywu@mail.cgu.edu.tw

Study Design

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

Study Record Dates

• First Submitted: November 15, 2020
• First Posted: December 7, 2020
• Study Start: July 4, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 11, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)