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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

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.

Condition or disease Intervention/treatment Phase
Stroke Device: M1 stimulation Device: PMC stimulation Device: aIPS stimulation Behavioral: hand motor task Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Dual Site-dual Channel Non-invasive Brain Stimulation for Recovery of Motor Function in Stroke Patients
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
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.
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

Behavioral: hand motor task
hand motor task for 30 minutes during transcranial direct current stimulation

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.
Device: M1 stimulation
stimulating primary motor cortex with anodal transcranial direct current stimulation
Other Name: primary motor 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

Experimental: Single stimulation
anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex
Device: M1 stimulation
stimulating primary motor cortex with anodal transcranial direct current stimulation
Other Name: primary motor cortex anodal stimulation

Behavioral: hand motor task
hand motor task for 30 minutes during transcranial direct current stimulation




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. changes in box and block test [ Time Frame: Baseline and after intervention (approximately 2 weeks) ]
    box and block test measures unilateral gross manual dexterity



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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03486769


Contacts
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Contact: Yun-Hee Kim, MD, Phd +82-2-3410-2818 yun1225.kim@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Yun-Hee Kim, MD, PhD    82-2-3410-2824    yunkim@skku.edu   
Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03486769     History of Changes
Other Study ID Numbers: 2017-08-124-A
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samsung Medical Center:
transcranial direct current stimulation
dual stimulation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases