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

• ClinicalTrials.gov Identifier: NCT04578080
• Recruitment Status: Recruiting
• First Posted: October 8, 2020
• Last Update Posted: March 9, 2022
• Sponsor: Mahidol University
• Information provided by (Responsible Party): Mahidol University

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.

Condition or disease	Intervention/treatment	Phase
Stroke, Acute	Device: Transcranial direct current stimulation	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of tDCS on Motor Functions and Brain Activity in Acute Stroke Patients
• Actual Study Start Date: October 1, 2020
• Estimated Primary Completion Date: October 1, 2022
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Anodal-tDCS & PT; 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.	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.
Active Comparator: Sham-tDCS & PT; 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Electroencephalography [ Time Frame: 10 minutes ]
   Brain activity will be recorded during eyes open (5 minutes) follow by eyes close (5 minutes).

Secondary Outcome Measures :

1. Fugl-Meyer Assessment [ Time Frame: 20 minutes ]
   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.

Other Outcome Measures:

1. Wolf Motor Function Test [ Time Frame: 5 minutes ]
   Two sub-items (lift a can and lift a pencil) will be evaluated in all participants.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Wanalee Klomjai, PhD; +66926194556; wanalee.klo@mahidol.edu

Locations

Thailand

Siriraj Hospital; Recruiting

Bangkok Noi, Bangkok, Thailand

Contact: Wanalee Klomjai, PhD +6624415450 ext 20216 wanalee.klo@mahidol.edu

Principal Investigator: Wanalee Klomjai, PhD

Principal Investigator: Benchaporn Aneksan, PhD

Principal Investigator: Oranich Vimolratana, MSc

Sponsors and Collaborators

Mahidol University

Investigators

• Study Director: Wanalee Klomjai, PhD; MU

More Information

• Responsible Party: Mahidol University
• ClinicalTrials.gov Identifier: NCT04578080
• Other Study ID Numbers: SI284/2020
• First Posted: October 8, 2020
• Last Update Posted: March 9, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases