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

NCT ID: NCT04577287

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2021-12-01

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.

Conditions

Stroke, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cathodal tDCS & PT

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 .

Group Type: EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type: DEVICE

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.

Anodal-tDCS & PT

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 .

Group Type: EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type: DEVICE

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.

Interventions

Transcranial direct current stimulation

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wanalee Klomjai, PhD

Role: STUDY_DIRECTOR

MU

Locations

Faculty ofPhysical Therapy, Mahidol University

Salaya, Nakonpathom, Thailand

Countries

Thailand

Other Identifiers

SI-2842019

Identifier Type: -

Identifier Source: org_study_id