Clinical trial NCT04577287: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: 20 minutes
measure: Wolf Motor Function Test
timeFrame: 5 minutes
measure: Five Times Sit to Stand Test
timeFrame: 5 minutes
measure: Time-up and go test
timeFrame: 5 minutes
measure: Muscle strength
timeFrame: 10 minutes
Secondary outcomes:
measure: Hemodynamic response (VMR%)
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Salaya
country: Thailand
facility: Faculty ofPhysical Therapy, Mahidol University
state: Nakonpathom
Study officials:
affiliation: MU
name: Wanalee Klomjai, PhD
role: STUDY_DIRECTOR
References: