NCT04578080

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

1.7 years

First QC Date

October 1, 2020

Last Update Submit

June 19, 2022

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

  • Electroencephalography

    Brain activity will be recorded during eyes open (5 minutes) follow by eyes close (5 minutes).

    10 minutes

Secondary Outcomes (1)

  • Fugl-Meyer Assessment

    20 minutes

Other Outcomes (1)

  • Wolf Motor Function Test

    5 minutes

Study Arms (2)

Anodal-tDCS & PT

EXPERIMENTAL

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

Sham-tDCS & PT

ACTIVE COMPARATOR

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

Interventions

Transcranial direct current stimulationDEVICE

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.

Anodal-tDCS & PTSham-tDCS & PT

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-75 years old
  • First-ever acute ischemic stroke of anterior circulation system (anterior cerebral artery or middle cerebral artery territory)
  • Stroke onset from 2-10 days
  • Having a stable medical condition
  • Alert of consciousness
  • Able to follow commands
  • Modified Rankin Scale (mRS) ≤ 4

You may not qualify if:

  • Hemorrhagic stroke
  • Recurrent stroke
  • Presence of other neurological disorders such as unilateral neglect
  • Presence of metal implantation, intracranial shunt, cochlear implantation or cardiac pacemakers
  • Presence of opened wound or infectious wound around scalp
  • History of epilepsy or any neurological antecedent or unstable condition which can lead to seizure
  • Body Mass Index (BMI) \> 30 kg/m2
  • Received hormonal treatment
  • Ischemic heart disease and peripheral vascular ischemia
  • Last stage of kidney disease and liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok Noi, Bangkok, Thailand

Location

Related Publications (1)

  • Vimolratana O, Aneksan B, Siripornpanich V, Hiengkaew V, Prathum T, Jeungprasopsuk W, Khaokhiew T, Vachalathiti R, Klomjai W. Effects of anodal tDCS on resting state eeg power and motor function in acute stroke: a randomized controlled trial. J Neuroeng Rehabil. 2024 Jan 3;21(1):6. doi: 10.1186/s12984-023-01300-x.

    PMID: 38172973DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Wanalee Klomjai, PhD

    MU

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 1, 2020

First Posted

October 8, 2020

Study Start

October 1, 2020

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)