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

Stroke, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04578080
• Other study ID #: SI284/2020
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2022
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Device:
• Transcranial direct current stimulation
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.

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Wolf Motor Function Test	Two sub-items (lift a can and lift a pencil) will be evaluated in all participants.	5 minutes
Primary	Electroencephalography	Brain activity will be recorded during eyes open (5 minutes) follow by eyes close (5 minutes).	10 minutes
Secondary	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.	20 minutes