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The Effects of Anodal and Cathodal tDCS Combined With Conventional Physical Therapy in Patients With Acute Stroke

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. Acute ischemic stroke patients who have aged between 18 and 75 years
  2. Having a first ever-ischemic stroke that are confirmed by MRI/CT scan
  3. Post stroke onset 2-10 days
  4. Be able to follow command
  5. Be able to walk with or without assistive device (Modified Ranking Scale ≤ 4)
  6. Free of any neurological antecedent or unstable condition (such as epilepsy) or cancer.
  7. Be able to initiate the upper limb movement

Exclusion Criteria:

  1. Recurrent stroke
  2. National Institute of Health Stroke Scale ≥ 20 points
  3. Presence of intracranial metal implantation, cochlear implant, or cardiac pacemaker
  4. Having excessive pain in any joint of the lower limb (numerical pain rating score > 4/10)
  5. Having an open wound or wound infraction on scalp
  6. Having neglect or psychological diseases (such as schizophrenia, major depression)

Sites / Locations

  • Faculty ofPhysical Therapy, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cathodal tDCS & PT

Anodal-tDCS & PT

Arm Description

Cathodal transcranial direct current stimulation (tDCS) will be applied for 20 mins before conventional physical therapy (about 1 hour). Cathode on the on the motor area (M1) of the affected hemisphere, anode on the supraorbital area of the unaffect 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 cerebral hemodynamic .

Anodal transcranial direct current stimulation (tDCS) will be applied for 20 mins before conventional physical therapy (about 1 hours). Anode on the motor are (M1) of the affected hemisphere, and 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 cerebral hemodynamic .

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment
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.
Wolf Motor Function Test
The participants will be asked to perform 2 items that consist of reaching a can and reaching a pen because two tasks is the most common reaching task of hand functions in daily living activities.
Five Times Sit to Stand Test
Subjects will sits on the chair and place their back against the chair. Timing will begin at "GO", the subjects will be asked to walk 3m, turn, walk back, and sit down. The stopwatch stops when the patient's buttocks touch the seat.
Time-up and go test
The TUG test is a commonly used screening tool to measure basic mobility correlating to dynamic balance. Start from sitting, stand up, walk 3 meters, turn around, walk back 3 meters and sit down. Timed to complete the task represent the body transfer and gait performance
Muscle strength
The strength of UE (shoulder flexor, shoulder extensor, elbow extensor, wrist extensor) and LE (hip extensor, hip flexor, knee extensor and ankle dorsiflexor) will be assessed by hand-held dynamometer

Secondary Outcome Measures

Hemodynamic response (VMR%)
cerebral blood flow velocity (CBFV), cerebral vasomotor reactivity (VMR) that is the capability of cerebral small vessels to respond to a stimulus

Full Information

First Posted
October 1, 2020
Last Updated
July 3, 2022
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT04577287
Brief Title
The Effects of Anodal and Cathodal tDCS Combined With Conventional Physical Therapy in Patients With Acute Stroke
Official Title
The Effects of Anodal and Cathodal Transcranial Direct Current Stimulation Combined With Conventional Physical Therapy in Patients With Acute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (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
The objective of the study is thus to compare the effects 5 consecutive sessions of anodal and cathodal tDCS combined with conventional physical therapy on upper and lower limb motor performance in acute stroke at immediate, and 1-month followup.
Detailed Description
Stroke is a major cause of long-term disability in stroke survivors that related with motor impairment. After stroke, the cortical excitability of ipsilesional hemisphere is decreased; in contrast, the cortical excitability of contralesional hemisphere is increased. Conventional physical therapy is beneficial to motor recovery, but early rehabilitation was not always help the patients get full recovery. tDCS is an adjuvant tools which deliver weak direct current through scalp to promote motor recovery in stroke rehabilitation. The anodal-tDCS increases cortical excitability, while the cathodal-tDCS decreases cortical excitability. Previous studies demonstrated that both monocephalic techniques of tDCS can improve motor function in chronic, subacute, and acute phase, but it is still inconclusive that which monocephalic montages had better effect, especially in acute phase. There are several studies supported the benefits of monocephalic tDCS combined with rehabilitation programs on upper and lower limbs motor function in acute stroke. However, there is no evidence that directly compared the effect of monocephalic tDCS in acute stroke patients. The objective of the study is to compare the effects of anodal and cathodal tDCS combined with conventional physical therapy for 5 sessions on motor performance in acute stroke at immediate, and 1-month follow-up.

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
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cathodal tDCS & PT
Arm Type
Experimental
Arm Description
Cathodal transcranial direct current stimulation (tDCS) will be applied for 20 mins before conventional physical therapy (about 1 hour). Cathode on the on the motor area (M1) of the affected hemisphere, anode on the supraorbital area of the unaffect 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 cerebral hemodynamic .
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). Anode on the motor are (M1) of the affected hemisphere, and 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 cerebral hemodynamic .
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
Cathodal/Anodal 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
Fugl-Meyer Assessment
Description
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
Title
Wolf Motor Function Test
Description
The participants will be asked to perform 2 items that consist of reaching a can and reaching a pen because two tasks is the most common reaching task of hand functions in daily living activities.
Time Frame
5 minutes
Title
Five Times Sit to Stand Test
Description
Subjects will sits on the chair and place their back against the chair. Timing will begin at "GO", the subjects will be asked to walk 3m, turn, walk back, and sit down. The stopwatch stops when the patient's buttocks touch the seat.
Time Frame
5 minutes
Title
Time-up and go test
Description
The TUG test is a commonly used screening tool to measure basic mobility correlating to dynamic balance. Start from sitting, stand up, walk 3 meters, turn around, walk back 3 meters and sit down. Timed to complete the task represent the body transfer and gait performance
Time Frame
5 minutes
Title
Muscle strength
Description
The strength of UE (shoulder flexor, shoulder extensor, elbow extensor, wrist extensor) and LE (hip extensor, hip flexor, knee extensor and ankle dorsiflexor) will be assessed by hand-held dynamometer
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Hemodynamic response (VMR%)
Description
cerebral blood flow velocity (CBFV), cerebral vasomotor reactivity (VMR) that is the capability of cerebral small vessels to respond to a stimulus
Time Frame
15 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: Acute ischemic stroke patients who have aged between 18 and 75 years Having a first ever-ischemic stroke that are confirmed by MRI/CT scan Post stroke onset 2-10 days Be able to follow command Be able to walk with or without assistive device (Modified Ranking Scale ≤ 4) Free of any neurological antecedent or unstable condition (such as epilepsy) or cancer. Be able to initiate the upper limb movement Exclusion Criteria: Recurrent stroke National Institute of Health Stroke Scale ≥ 20 points Presence of intracranial metal implantation, cochlear implant, or cardiac pacemaker Having excessive pain in any joint of the lower limb (numerical pain rating score > 4/10) Having an open wound or wound infraction on scalp Having neglect or psychological diseases (such as schizophrenia, major depression)
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
Faculty ofPhysical Therapy, Mahidol University
City
Salaya
State/Province
Nakonpathom
ZIP/Postal Code
73170
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Anodal and Cathodal tDCS Combined With Conventional Physical Therapy in Patients With Acute Stroke

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