Stroke, AcuteNCT04578080
Effect of tDCS on Motor Functions and Brain Activity in Acute Stroke Patients
A study testing Transcranial direct current stimulation in people with Stroke, Acute, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2020to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke, Acute
- Being tested
- Transcranial direct current stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalography
Brain activity will be recorded during eyes open (5 minutes) follow by eyes close (5 minutes).
Measured: 10 minutes
Secondary outcomes (1)
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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Oct 2020
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wanalee Klomjai, PhD, Study director, MU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578080
- Sponsor's protocol ID
- SI284/2020
- Status last verified
- Jun 2022
- First submitted
- 1 Oct 2020
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38172973
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of tDCS on Motor Functions and Brain Activity in Acute Stroke Patients
- ClinicalTrials.gov ID
- NCT04578080
- Acronym / sponsor ID
- SI284/2020
- Conditions
- Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal-tDCS & PT | Experimental | Device: Transcranial direct current stimulationAnodal 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. |
| Sham-tDCS & PT | Active comparator | Device: Transcranial direct current stimulationAnodal 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulationAnodal 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. | Device | Anodal-tDCS & PT, Sham-tDCS & PT |
Primary outcome
Electroencephalography
Time frame: 10 minutes
Brain activity will be recorded during eyes open (5 minutes) follow by eyes close (5 minutes).
1 secondary outcome
Fugl-Meyer Assessment
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Derived from this study: PubMed 38172973Vimolratana 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.
- Individual participant dataSharing planned: No
Related trials for Stroke, Acute
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wanalee Klomjai, PhD study director
MU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Stroke, Acute, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalography (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04578080, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.