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Effect of tDCS on Motor Functions and Brain Activity in Acute Stroke Patients

Primary Purpose

Stroke, Acute

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age between 18-75 years old
  2. First-ever acute ischemic stroke of anterior circulation system (anterior cerebral artery or middle cerebral artery territory)
  3. Stroke onset from 2-10 days
  4. Having a stable medical condition
  5. Alert of consciousness
  6. Able to follow commands
  7. Modified Rankin Scale (mRS) ≤ 4

Exclusion Criteria:

  1. Hemorrhagic stroke
  2. Recurrent stroke
  3. Presence of other neurological disorders such as unilateral neglect
  4. Presence of metal implantation, intracranial shunt, cochlear implantation or cardiac pacemakers
  5. Presence of opened wound or infectious wound around scalp
  6. History of epilepsy or any neurological antecedent or unstable condition which can lead to seizure
  7. Body Mass Index (BMI) > 30 kg/m2
  8. Received hormonal treatment
  9. Ischemic heart disease and peripheral vascular ischemia
  10. Last stage of kidney disease and liver disease

Sites / Locations

  • Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anodal-tDCS & PT

Sham-tDCS & PT

Arm Description

Anodal transcranial direct current stimulation (tDCS) will be applied for 20 mins before conventional physical therapy (about 1 hours). Anodal on the motor area (M1) of affected hemisphere, Cathodal on the supraorbital area of unaffected hemisphere. Current intensity is fixed at 1.5 mA and current will flow continuously. Physical therapist will give an intervention program base on the same basic conventional physical therapy treatment. The scope of intervention is administered to improve motor functions and brain activity.

Anodal transcranial direct current stimulation (tDCS) will be applied for 20 mins before conventional physical therapy (about 1 hours). Anodal on the motor area of affected hemisphere, Cathodal on the supraorbital area of affected hemisphere. Physical therapist will give an intervention program base on the same basic conventional physical therapy treatment. The scope of intervention is administered to improve motor functions and brain activity.

Outcomes

Primary Outcome Measures

Electroencephalography
Brain activity will be recorded during eyes open (5 minutes) follow by eyes close (5 minutes).

Secondary Outcome Measures

Fugl-Meyer Assessment
The gold standard and widely used tool to assess sensorimotor in stroke. The item from upper limb and lower limb section will be used. The items are rated on a 3-point ordinal scale as follows: 0 = unable to perform; 1 = partial ability to perform; and 2 = near normal ability to perform.

Full Information

First Posted
October 1, 2020
Last Updated
June 19, 2022
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT04578080
Brief Title
Effect of tDCS on Motor Functions and Brain Activity in Acute Stroke Patients
Official Title
Effect of tDCS on Motor Functions and Brain Activity in Acute Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to investigate the effects of anodal tDCS combined with conventional physical therapy for 5 consecutive sessions on motor functions and brain activity in acute stroke patients at immediate and 1-month follow-up.
Detailed Description
Stroke or cerebrovascular accident is a leading cause of disabilities. Physical therapy is a standard treatment to help motor recovery after stroke. However, disabilities remained in some stroke patients despite intensive training. After stroke, there are changes of cortical excitability and brain activity in both hemispheres. Lesioned hemisphere decreases cortical excitability and increases number of low-frequency brain activity, while the non-lesioned hemisphere increases cortical excitability and increases number of high-frequency brain activity. Transcranial direct current stimulation (tDCS) is a technique which delivers weak direct current through scalp and can be used as an adjunctive treatment. Anodal tDCS can increase cortical excitability and amount of high-frequency brain activity. Increased amount of high-frequency brain activity in the lesioned hemisphere can indicate better recovery of stroke. Meta-analysis has reported the benefits of anodal tDCS for motor recovery in stroke patients. However, only few studies have investigated tDCS effects in acute phase of stroke which is a crucial time for enhancing motor recovery. This study aims to investigate the effects of anodal- and cathodal tDCS combined with conventional physical therapy for 5 consecutive sessions on motor functions and brain activity in acute stroke patients at immediate and 1-month follow-up. Participants will be randomly assigned into 2 groups (sham-, and anodal tDCS). Participants in the anodal group will receive 1.5 mA tDCS for 20 minutes before physical therapy programs for 5 consecutive sessions, while the sham group will receive sham tDCS with physical therapy. Brain activity by electroencephalography and motor performances by Fugl-Meyer Assessment and Wolf Motor Function Test will be evaluated at baseline, post-intervention (day 5), and follow-up at 1 month. We hypothesize that anodal tDCS combined with physical therapy for 5 consecutive days can immediately increase number of high-frequency brain activity and improve motor functions and this effect will last for a month compared to the sham group.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anodal-tDCS & PT
Arm Type
Experimental
Arm Description
Anodal transcranial direct current stimulation (tDCS) will be applied for 20 mins before conventional physical therapy (about 1 hours). Anodal on the motor area (M1) of affected hemisphere, Cathodal on the supraorbital area of unaffected hemisphere. Current intensity is fixed at 1.5 mA and current will flow continuously. Physical therapist will give an intervention program base on the same basic conventional physical therapy treatment. The scope of intervention is administered to improve motor functions and brain activity.
Arm Title
Sham-tDCS & PT
Arm Type
Active Comparator
Arm Description
Anodal transcranial direct current stimulation (tDCS) will be applied for 20 mins before conventional physical therapy (about 1 hours). Anodal on the motor area of affected hemisphere, Cathodal on the supraorbital area of affected hemisphere. Physical therapist will give an intervention program base on the same basic conventional physical therapy treatment. The scope of intervention is administered to improve motor functions and brain activity.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
Anodal or Sham tDCS will be applied in 1.5 mA, 20 mins before conventional physical therapy for 5 days. All experiments will be performed in random order for each subject.
Primary Outcome Measure Information:
Title
Electroencephalography
Description
Brain activity will be recorded during eyes open (5 minutes) follow by eyes close (5 minutes).
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment
Description
The gold standard and widely used tool to assess sensorimotor in stroke. The item from upper limb and lower limb section will be used. The items are rated on a 3-point ordinal scale as follows: 0 = unable to perform; 1 = partial ability to perform; and 2 = near normal ability to perform.
Time Frame
20 minutes
Other Pre-specified Outcome Measures:
Title
Wolf Motor Function Test
Description
Two sub-items (lift a can and lift a pencil) will be evaluated in all participants.
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18-75 years old First-ever acute ischemic stroke of anterior circulation system (anterior cerebral artery or middle cerebral artery territory) Stroke onset from 2-10 days Having a stable medical condition Alert of consciousness Able to follow commands Modified Rankin Scale (mRS) ≤ 4 Exclusion Criteria: Hemorrhagic stroke Recurrent stroke Presence of other neurological disorders such as unilateral neglect Presence of metal implantation, intracranial shunt, cochlear implantation or cardiac pacemakers Presence of opened wound or infectious wound around scalp History of epilepsy or any neurological antecedent or unstable condition which can lead to seizure Body Mass Index (BMI) > 30 kg/m2 Received hormonal treatment Ischemic heart disease and peripheral vascular ischemia Last stage of kidney disease and liver disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wanalee Klomjai, PhD
Organizational Affiliation
MU
Official's Role
Study Director
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkok Noi
State/Province
Bangkok
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of tDCS on Motor Functions and Brain Activity in Acute Stroke Patients

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