Hemodynamic Response and Motor Functions Following Transcranial Direct Current Stimulation in Acute Stroke

NCT04051658 | Completed

• 1 other identifier: MU-CIRB 2018/238.0712
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to evaluate the possible effect of using dual-tDCS applied before conventional physical therapy on motor functions and hemodynamic response

Conditions

Stroke; Acute

Keywords

Stroke; Acute; tDCS; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Cerebral blood flow velocity

  Participants undergoTCCD in the supine position to measure blood flow velocity. in each middle cerebral artery through temporal bone

  15 minutes

Secondary Outcomes (4)

• Fugl-Meyer Assessment

  20 minutes

• Muscle strength

  10 minutes

• Time-up and go test

  5 minutes

• Five Times Sit to Stand Test

  5 minutes

Study Arms (4)

Anodal-tDCS & PT

EXPERIMENTAL

Anodal transcranial direct current stimulation (tDCS) will be applied for 20 mins before conventional physical therapy (about 1 hour). Anodal on the motor area (M1) of the affected hemisphere, Cathodal on the contralateral supraorbital area. The current intensity is fixed at 1.5 mA and the current will flow continuously. The 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.

Device: Transcranial direct current stimulation

Cathodal-tDCS & PT

EXPERIMENTAL

Cathodal transcranial direct current stimulation (tDCS) will be applied for 20 mins before conventional physical therapy (about 1 hour). Anodal on the supraorbital area of the affected hemisphere, Cathodal on the primary motor area (M1) of the unaffected hemisphere. The current intensity is fixed at 1.5 mA and the current will flow continuously. The 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.

Device: Transcranial direct current stimulation

Dual-tDCS & PT

EXPERIMENTAL

Dual transcranial direct current stimulation (tDCS) will be applied over C3-C4 or the motor area (M1) for 20 mins before conventional physical therapy (about 1 hour). Anodal on the affected hemisphere, Cathodal on the unaffected hemisphere. The current intensity is fixed at 1.5 mA and the current will flow continuously. The 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.

Device: Transcranial direct current stimulation

Sham-tDCS & PT

SHAM COMPARATOR

Dual transcranial direct current stimulation (tDCS) in sham mode will be applied over C3-C4 or the motor area (M1) for 20 mins before conventional physical therapy (about 1 hour). Anodal on the affected hemisphere, Cathodal on the unaffected hemisphere. The 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 .

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulation DEVICE

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; Cathodal-tDCS & PT; Dual-tDCS & PT; Sham-tDCS & PT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18 and 75 years of age
• First ever-acute ischemic unilateral stroke in the anterior circulation (ACA or MCA territory), MRI/CT scan result is thus required.
• Stroke onset from 2-10 days
• Good level of consciousness (alert)
• Free of any neurological antecedent, unstable condition that may increase the risk of stimulation such as epilepsy; although tDCS is believed to induce less or no risk of seizure and epileptic seizure have never been reported in tDCS study even in a study with active epilepsy (19).
• No significant carotid artery occlusive disease (\< 50% internal carotid artery stenosis) as assessed by carotid duplex ultrasonography
• Modified Ranking Scale ≤ 4

You may not qualify if:

• Recurrent stroke
• Having score more than 20 points on the National Institute of Health Stroke Scale
• Be unable to understand the instruction.
• Presence of intracranial metal implantation, cochlear implant, or cardiac pacemaker.
• Having as excessive pain in any joint of the lower limb (numerical pain rating score \> 7)
• Open wound or wound infraction on scalp

Sponsors & Collaborators

• Mahidol University: lead
• National Research Council of Thailand: collaborator

Study Sites (1)

Faculty of Physical Therapy, Mahidol University

Salaya, Nakonpathom, 73170, Thailand

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Wanalee Klomjai, Ph.D

  Mahidol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a four-arm parallel assignment involves four groups of participants which consists of anodal-, cathodal-, dual- and sham tDCS.

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 9, 2019
• Study Start: August 6, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)