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Efficacy of Transcranial Direct Current Stimulation in Acute Ischemic Stroke (DAS)

Primary Purpose

Ischemic Stroke

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
Incheon St.Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ischemic stroke patients within 2 days stroke onset
  • 18-85 of age
  • corticospinal tract involvement stroke (primary motor cortex, corona radiata, internal capsule, midbrain crus cerebri, basis pontis, anterior medulla)

Exclusion Criteria:

  • pre-stroke disability (defined as modified Rankin Scale (mRS) >=2)
  • Intravenous r-tPA thrombolysis or EVT (endovascular thrombectomy)
  • history of epilepsy
  • advanced systemic disease or coexisting neurological/psychiatric disease
  • severe contact dermatitis or skin lesions interfering with the applying the electrode of tDCS

Sites / Locations

  • The Catholic University of Korea, Incheon St. Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

tDCS group

Sham group

Arm Description

tDCS stimulation affected side : primary motor cortex (M1 cortex by using the C3 or C4 position of the 10-20 EEG system) 2mA anode (+) for 30 minutes total 10 times for 7 days (ex) twice a day for 5 days) contralateral unaffected side primary motor cortex (M1 cortex by using the C3 or C4 position of the 10-20 EEG system) 2mA cathode (-) for 30 minutes total 10 times for 7 days (ex) twice a day for 5 days)

. Sham stimulation 1) the current ramps up to 2mA and slowly decreased over 30 s to ensure the typical initial tingling sensation

Outcomes

Primary Outcome Measures

Fugl-Meyer (FM) motor scale, short form
The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).
Fugl-Meyer (FM) motor scale, short form
The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).
Fugl-Meyer (FM) motor scale, short form
The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).
NIHSS (National Institutes of Health Stroke Scale)
National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).
NIHSS (National Institutes of Health Stroke Scale)
National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).
NIHSS (National Institutes of Health Stroke Scale)
National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).

Secondary Outcome Measures

modified Rankin scale
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It has become the most widely used clinical outcome measure for stroke clinical trials.

Full Information

First Posted
June 15, 2021
Last Updated
June 24, 2021
Sponsor
Incheon St.Mary's Hospital
Collaborators
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT04938076
Brief Title
Efficacy of Transcranial Direct Current Stimulation in Acute Ischemic Stroke
Acronym
DAS
Official Title
Investigation of the Effects of Noninvasive Neuromodulation in Patients With Acute Ischemic Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Incheon St.Mary's Hospital
Collaborators
The Catholic University of Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Non-invasive brain stimulation (tDCS) such as transcranial direct current stimulation (TDCS) has been reported to be effective in improving motor performance and safe in participants with cerebral infarction. However, few studies have been done in participants with acute cerebral infarction. In this study, the investigators want to see the effect of tDCS in acute cerebral infarction. the investigators perform tDCS in participants with acute ischemic stroke within 48 hours after stroke onset and the investigators measure motor weakness and function at early phase as well as at 3 months.
Detailed Description
Cerebral infarction is a major cause of death, a disease that is socially and nationally burdensome, leaving disabilities and dementia behind. In participants with cerebral infarction, non-invasive brain stimulation (tDCS) such as transcranial direct current stimulation (TDCS) has been reported to be effective in improving motor performance and safe. However, few studies have been done in participants with acute cerebral infarction, and previous studies in participants with acute cerebral infarction have not verified the effect in mild cerebral infarction, and previous studies in acute cerebral infarction mainly stimulate lesions to anode. So in this study, the investigators want to see the effect of stimulating tDCS to both hemispheres in acute cerebral infarction against this backdrop. Study Objective: To see if tDCS is effective in improving motor paralysis in participants with acute cerebral infarction. Expected effectiveness: stability of tDCS has already been demonstrated in many studies. Since tDCS itself is a non-invasive treatment, if the efficacy of the tDCS prove to be effective in patients with acute cerebral infarction, it can be widely implemented without significant risk to many patients. Intervention : In this randomized controlled trial, the investigators perform tDCS in patients with acute ischemic stroke within 48 hours after stroke onset with sham control. Outcome : the investigators measure motor weakness and function at early phase as well as at 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Double blinded randomized control trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blinded randomized control trial
Allocation
Randomized
Enrollment
172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tDCS group
Arm Type
Experimental
Arm Description
tDCS stimulation affected side : primary motor cortex (M1 cortex by using the C3 or C4 position of the 10-20 EEG system) 2mA anode (+) for 30 minutes total 10 times for 7 days (ex) twice a day for 5 days) contralateral unaffected side primary motor cortex (M1 cortex by using the C3 or C4 position of the 10-20 EEG system) 2mA cathode (-) for 30 minutes total 10 times for 7 days (ex) twice a day for 5 days)
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
. Sham stimulation 1) the current ramps up to 2mA and slowly decreased over 30 s to ensure the typical initial tingling sensation
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
Transcranial direct current stimulation on motor cortex
Primary Outcome Measure Information:
Title
Fugl-Meyer (FM) motor scale, short form
Description
The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).
Time Frame
at admission
Title
Fugl-Meyer (FM) motor scale, short form
Description
The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).
Time Frame
at 7 days
Title
Fugl-Meyer (FM) motor scale, short form
Description
The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).
Time Frame
at 3 month
Title
NIHSS (National Institutes of Health Stroke Scale)
Description
National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).
Time Frame
at admission
Title
NIHSS (National Institutes of Health Stroke Scale)
Description
National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).
Time Frame
at 7 days
Title
NIHSS (National Institutes of Health Stroke Scale)
Description
National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).
Time Frame
at 3 month
Secondary Outcome Measure Information:
Title
modified Rankin scale
Description
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It has become the most widely used clinical outcome measure for stroke clinical trials.
Time Frame
at 3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ischemic stroke patients within 2 days stroke onset 18-85 of age corticospinal tract involvement stroke (primary motor cortex, corona radiata, internal capsule, midbrain crus cerebri, basis pontis, anterior medulla) Exclusion Criteria: pre-stroke disability (defined as modified Rankin Scale (mRS) >=2) Intravenous r-tPA thrombolysis or EVT (endovascular thrombectomy) history of epilepsy advanced systemic disease or coexisting neurological/psychiatric disease severe contact dermatitis or skin lesions interfering with the applying the electrode of tDCS
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taewon Kim, MD, PhD
Phone
+82-10-9399-5452
Email
kimtaewon79@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taewon Kim, MD, PhD
Organizational Affiliation
Incheon St.Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Catholic University of Korea, Incheon St. Mary's Hospital
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taewon Kim, MD, PhD
Phone
+82-10-9399-5452
Email
kimtaewon79@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Transcranial Direct Current Stimulation in Acute Ischemic Stroke

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