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Dual Site-dual Channel Non-invasive Brain Stimulation for Motor Function in Stroke Patients

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ClinicalTrials.gov Identifier: NCT03486769
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE March 22, 2018
First Posted Date  ICMJE April 3, 2018
Last Update Posted Date September 19, 2019
Actual Study Start Date  ICMJE May 1, 2018
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2018)
Changes in motor evoked potentia [ Time Frame: Baseline and after intervention (approximately 2 weeks) ]
measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03486769 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2018)
  • changes in nine hole peg test [ Time Frame: Baseline and after intervention (approximately 2 weeks) ]
    Nine-Hole Peg Test is used to measure finger dexterity in patients with various neurological diagnoses.
  • changes in grip and tip pinch strength test [ Time Frame: Baseline and after intervention (approximately 2 weeks) ]
    measure the hand strength (grip and tip pinch)
  • changes in box and block test [ Time Frame: Baseline and after intervention (approximately 2 weeks) ]
    box and block test measures unilateral gross manual dexterity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dual Site-dual Channel Non-invasive Brain Stimulation for Motor Function in Stroke Patients
Official Title  ICMJE Effect of Dual Site-dual Channel Non-invasive Brain Stimulation for Recovery of Motor Function in Stroke Patients
Brief Summary The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of motor function in post stroke patients. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. All subjects will go through three conditions of transcranial direct current stimulation with for 30 minutes. Three conditions are 1) Dual stimulation 1: i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional premotor cortex and cathodal stimulation on contralesional supraorbital area. 2) Dual stimulation 2: i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional anterior intraparietal sulcus and cathodal stimulation on contralesional supraorbital area. 3) Single stimulation: anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • Device: M1 stimulation
    stimulating primary motor cortex with anodal transcranial direct current stimulation
    Other Name: primary motor cortex anodal stimulation
  • Device: PMC stimulation
    stimulating premotor cortex with anodal transcranial direct current stimulation
    Other Name: premotor cortex anodal stimulation
  • Device: aIPS stimulation
    stimulating anterior intraparietal sulcus with anodal transcranial direct current stimulation
  • Behavioral: hand motor task
    hand motor task for 30 minutes during transcranial direct current stimulation
Study Arms  ICMJE
  • Experimental: Dual Stimulation 1
    i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional premotor cortex and cathodal stimulation on contralesional supraorbital area.
    Interventions:
    • Device: M1 stimulation
    • Device: PMC stimulation
    • Behavioral: hand motor task
  • Experimental: Dual Stimulation 2
    i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional anterior intraparietal sulcus and cathodal stimulation on contralesional supraorbital area.
    Interventions:
    • Device: M1 stimulation
    • Device: aIPS stimulation
    • Behavioral: hand motor task
  • Experimental: Single stimulation
    anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex
    Interventions:
    • Device: M1 stimulation
    • Behavioral: hand motor task
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 20, 2018)
36
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2018)
48
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • unilateral hemiplegic stroke patient
  • Fugl Meyer Assessment score between 9 to 84

Exclusion Criteria:

  • difficult to understand experimental tasks because of extremely severe cognitive impairment
  • history of psychiatric disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yun-Hee Kim, MD, Phd +82-2-3410-2818 yun1225.kim@samsung.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03486769
Other Study ID Numbers  ICMJE 2017-08-124-A
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Samsung Medical Center
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP