NCT02827864

Brief Summary

This project is designed to investigate the intervention effects and time dependent effects of combining tDCS and MT in patients with subacute and chronic stroke.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 30, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2020

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

4 months

First QC Date

June 29, 2016

Last Update Submit

June 16, 2020

Conditions

Cerebrovascular Accident

Keywords

Mirror therapytranscranial direct current stimulationstrokeneurorehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change scores of Fugl-Meyer Assessment (FMA)

    The UE-FMA subscale will be used to assess the sensorimotor impairment level of UE in patients after stroke. The UE-FMA contains 33 movements with a score range from 0 to 66. A higher UE-FMA score indicates less impairment of the paretic limb. The validity and reliability of FMA is good to excellent.

    baseline, 1 month, 4 months

Secondary Outcomes (23)

  • Change scores of Adelaide Activities Profile (AAP)

    baseline, 1 month

  • Change scores of 10-Meter Walk Test (10MWT)

    baseline, 1 month

  • Change scores of Stroop test

    baseline, 1 month

  • Change scores of pressure pain threshold

    baseline, 1 month

  • Change scores of Dual-Task Block and Box Test

    baseline, 1 month, 4 months

  • +18 more secondary outcomes

Study Arms (3)

sequentially apply tDCS and MT

EXPERIMENTAL

The participants in the SEQ group will first receive a-tDCS applied over M1 lesioned without any active arm practice for 20 minutes. For the following 20 minutes, the participants will receive the MT, while the electrodes will be remained on the scalp without stimulation (sham tDCS). Then the electrodes will be removed from the scalp, and the participants will continue another 20 minutes of MT without tDCS. The treatment session will be ended with 30 minutes of functional task practice.

Behavioral: sequentially apply tDCS and MT

apply tDCS concurrently

EXPERIMENTAL

For the participants in the CON group, sham tDCS will be first applied for 20 minutes without active arm practice. Twenty minutes of a-tDCS will then be applied concurrently with MT followed by another 20 minutes of MT without tDCS. Similar to the SEQ group, the participants will also practice functional tasks for 30 minutes after MT.

Behavioral: apply tDCS concurrently

MT with sham tDCS

SHAM COMPARATOR

For the SHAM group, the training procedure will be the same as the above 2 groups except that sham tDCS will be provided in the first 40 minutes.

Behavioral: MT with sham tDCS

Interventions

sequentially apply tDCS and MTBEHAVIORAL

The participants in the SEQ group will first receive a-tDCS applied over M1lesioned without any active arm practice for 20 minutes. For the following 20 minutes, the participants will receive the MT, while the electrodes will be remained on the scalp without stimulation (sham tDCS). Then the electrodes will be removed from the scalp, and the participants will continue another 20 minutes of MT without tDCS. The treatment session will be ended with 30 minutes of functional task practice.

Also known as: SEQ
sequentially apply tDCS and MT
apply tDCS concurrentlyBEHAVIORAL

Sham tDCS will be first applied for 20 minutes without active arm practice. Twenty minutes of a-tDCS will then be applied concurrently with MT followed by another 20 minutes of MT without tDCS. The participants will also practice functional tasks for 30 minutes after MT.

Also known as: CON
apply tDCS concurrently
MT with sham tDCSBEHAVIORAL

The training procedure will be the same as the above 2 groups except that sham tDCS will be provided in the first 40 minutes.

Also known as: SHAM
MT with sham tDCS

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • experienced a first-ever unilateral stroke with stroke onset ≥ 1 week;
  • UE-FMA score between 18 and 56
  • able to follow instructions to perform the tasks (Mini Mental State Examination ≥ 24)

You may not qualify if:

  • Participants are currently involved in other rehabilitation or drug research trial(s);
  • have neurological or psychological disorders other than stroke;
  • have joint contracture or excessive spasticity of the paretic upper limb that prohibits them performing the tasks;
  • received Botulinum toxin injections 3 months prior to 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chang Gung Memorial Hospital

Songshan, Taipei, 105, Taiwan

Location

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

  • Liao WW, Chiang WC, Lin KC, Wu CY, Liu CT, Hsieh YW, Lin YC, Chen CL. Timing-dependent effects of transcranial direct current stimulation with mirror therapy on daily function and motor control in chronic stroke: a randomized controlled pilot study. J Neuroeng Rehabil. 2020 Jul 20;17(1):101. doi: 10.1186/s12984-020-00722-1.

    PMID: 32690032DERIVED

MeSH Terms

Conditions

Stroke

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ching-Yi Wu

    Chang Gung University

    STUDY CHAIR

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

June 29, 2016

First Posted

July 11, 2016

Study Start

October 30, 2017

Primary Completion

February 28, 2018

Study Completion

February 13, 2020

Last Updated

June 18, 2020

Record last verified: 2020-06

Locations

TW(2)