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Trial record 10 of 45 for:    NOT MRI NOT Imaging NOT intensive NOT auditory NOT thermal NOT mirror NOT TENS NOT tactile NOT motion NOT Passy NOT music NOT flow NOT vibration NOT fluid NOT ASIS NOT traditional | Recruiting, Not yet recruiting, Available Studies | Stroke | Deep Brain Stimulation OR magnetic OR transcranial direct current

High-definition Transcranial Direct Current Stimulation for Facilitating Hand Function Recovery After Stroke

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ClinicalTrials.gov Identifier: NCT03875677
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Raymond KY Tong, Chinese University of Hong Kong

Brief Summary:
Transcranial direct current stimulation (tDCS) had recently been shown having feasibility in modulating cortical excitability transiently during motor training in a noninvasive way. The findings support that tDCS and motor practice can positively promote post-stroke motor learning to improve upper-limb motor recovery after stroke. A randomized controlled trial will be conducted with three groups: HD-tDCS, conventional tDCS and sham HD-tDCS. A 10-session training will be provided to evaluate the effectiveness of transient modulation of cortical excitability through tDCS with clinical assessment scores.

Condition or disease Intervention/treatment Phase
Stroke Device: HD-tDCS group Device: Conventional tDCS group Device: Sham HD-tDCS group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using Neuroimage and Computational Modeling to Customize High-definition Transcranial Direct Current Stimulation Protocols for Facilitating Hand Function Recovery After Stroke
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

Arm Intervention/treatment
Experimental: HD-tDCS group
Constant current (2mA) will be applied for 20min and the anode will be placed over the defined target area
Device: HD-tDCS group
5 sintered Ag/AgCl ring electrodes will be used at a radius of ~5cm. The electrodes will be placed inside plastic electrode holders which will be filled with gel to have better contact with the scalp.

Experimental: Conventional tDCS group
Constant current (2mA) will be applied for 20min and the anode will be placed over the standard C3/C4 position
Device: Conventional tDCS group
A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.

Sham Comparator: Sham HD-tDCS group
The stimulator will be shut down after 30s of stimulation. The patients will feel the initial itching sensation at the beginning in order to evaluate the placebo effect.
Device: Sham HD-tDCS group
A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.




Primary Outcome Measures :
  1. Action Research Arm Test (ARAT) [ Time Frame: 3-month after the 10th session training ]
    The ARAT has total 19 items, divided into 4 categories (grasp, grip, pinch, and gross arm movement). It ranges from 3 to 0 (best to worse).


Secondary Outcome Measures :
  1. Fugl-Meyer Assessment (Upper Extremity) [ Time Frame: 3-month after the 10th session training ]
    The maximum score is 66, divided into 33 items in the form of a 3-point scale (0-2), 0 is cannot perform and 2 performs fully.

  2. Wolf Motor Function Test (WMFT) [ Time Frame: 3-month after the 10th session training ]
    The WMFT measures upper limb ability through timed and functional tasks. It has 17 items, ranging from 0 to 5 (worse to best).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Hemiparesis subsequent to first-ever unilateral stroke for more than 6 months;
  2. MCP and PIP finger joints can be extended to 180° passively;
  3. Sufficient cognition to follow the experimental instructions

Exclusion Criteria:

  1. Severe hand spasticity or hand deformity;
  2. History of alcohol or drug abuse or epilepsy;
  3. Bilateral brain infarcts;
  4. Severe cognitive deficits;
  5. Comprehensive aphasia;
  6. Contraindications to tDCS

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): NCT03875677


Contacts
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Contact: Raymond Tong, PhD +852 3943 8454 kytong@cuhk.edu.hk

Locations
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Hong Kong
Department of Biomedical Engineering, The Chinese University of Hong Kong Recruiting
Shatin, Hong Kong
Contact: Raymond Tong, PhD    +852 3943 8454    kytong@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Raymond Tong, PhD Department of Biomedical Engineering, CUHK

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Responsible Party: Raymond KY Tong, Chairman and Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03875677     History of Changes
Other Study ID Numbers: 2017.155
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
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
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases