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Completed

NCT Number: NCT04578080

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siriraj Hospital

Bangkok Noi, Bangkok, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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.

Primary outcomes

  1. Electroencephalography

    Time frame: 10 minutes

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

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 8, 2020
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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