Stroke, AcuteNCT04577287
The Effects of Anodal and Cathodal tDCS Combined With Conventional Physical Therapy in Patients With Acute Stroke
A study testing Transcranial direct current stimulation in people with Stroke, Acute, run by Mahidol University at 1 site in Thailand.
Trial summary
The objective of the study is thus to compare the effects 5 consecutive sessions of anodal and cathodal tDCS combined with conventional physical therapy on upper and lower limb motor performance in acute stroke at immediate, and 1-month followup. 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
- 36 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2020to 1 Dec 2021
- 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
- Acute ischemic stroke patients who have aged between 18 and 75 years
- Having a first ever-ischemic stroke that are confirmed by MRI/CT scan
- Post stroke onset 2-10 days
- Be able to follow command
- Be able to walk with or without assistive device (Modified Ranking Scale ≤ 4)
- Free of any neurological antecedent or unstable condition (such as epilepsy) or cancer.
- Be able to initiate the upper limb movement
Who cannot join
- Recurrent stroke
- National Institute of Health Stroke Scale ≥ 20 points
- Presence of intracranial metal implantation, cochlear implant, or cardiac pacemaker
- Having excessive pain in any joint of the lower limb (numerical pain rating score > 4/10)
- Having an open wound or wound infraction on scalp
- Having neglect or psychological diseases (such as schizophrenia, major depression)
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty ofPhysical Therapy, Mahidol University
Salaya, Nakonpathom, 73170
About this study
Official title: The Effects of Anodal and Cathodal Transcranial Direct Current Stimulation Combined With Conventional Physical Therapy in Patients With Acute Stroke
The objective of the study is thus to compare the effects 5 consecutive sessions of anodal and cathodal tDCS combined with conventional physical therapy on upper and lower limb motor performance in acute stroke at immediate, and 1-month followup.
Read the detailed description
Stroke is a major cause of long-term disability in stroke survivors that related with motor impairment. After stroke, the cortical excitability of ipsilesional hemisphere is decreased; in contrast, the cortical excitability of contralesional hemisphere is increased. Conventional physical therapy is beneficial to motor recovery, but early rehabilitation was not always help the patients get full recovery. tDCS is an adjuvant tools which deliver weak direct current through scalp to promote motor recovery in stroke rehabilitation. The anodal-tDCS increases cortical excitability, while the cathodal-tDCS decreases cortical excitability. Previous studies demonstrated that both monocephalic techniques of tDCS can improve motor function in chronic, subacute, and acute phase, but it is still inconclusive that which monocephalic montages had better effect, especially in acute phase. There are several studies supported the benefits of monocephalic tDCS combined with rehabilitation programs on upper and lower limbs motor function in acute stroke. However, there is no evidence that directly compared the effect of monocephalic tDCS in acute stroke patients. The objective of the study is to compare the effects of anodal and cathodal tDCS combined with conventional physical therapy for 5 sessions on motor performance in acute stroke at immediate, and 1-month follow-up.
- 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
Cathodal/Anodal 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 |
|---|---|---|
| Cathodal tDCS & PT | Experimental | Cathodal transcranial direct current stimulation (tDCS) will be applied for 20 mins before conventional physical therapy (about 1 hour). Cathode on the on the motor area (M1) of the affected hemisphere, anode on the supraorbital area of the unaffect 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 cerebral hemodynamic . Receives: Device: Transcranial direct current stimulation |
| Anodal-tDCS & PT | Experimental | Anodal transcranial direct current stimulation (tDCS) will be applied for 20 mins before conventional physical therapy (about 1 hours). Anode on the motor are (M1) of the affected hemisphere, and 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 cerebral hemodynamic . Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment
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
Wolf Motor Function Test
The participants will be asked to perform 2 items that consist of reaching a can and reaching a pen because two tasks is the most common reaching task of hand functions in daily living activities.
Measured: 5 minutes
Five Times Sit to Stand Test
Subjects will sits on the chair and place their back against the chair. Timing will begin at "GO", the subjects will be asked to walk 3m, turn, walk back, and sit down. The stopwatch stops when the patient's buttocks touch the seat.
Measured: 5 minutes
Time-up and go test
The TUG test is a commonly used screening tool to measure basic mobility correlating to dynamic balance. Start from sitting, stand up, walk 3 meters, turn around, walk back 3 meters and sit down. Timed to complete the task represent the body transfer and gait performance
Measured: 5 minutes
Muscle strength
The strength of UE (shoulder flexor, shoulder extensor, elbow extensor, wrist extensor) and LE (hip extensor, hip flexor, knee extensor and ankle dorsiflexor) will be assessed by hand-held dynamometer
Measured: 10 minutes
Secondary outcomes (1)
Hemodynamic response (VMR%)
cerebral blood flow velocity (CBFV), cerebral vasomotor reactivity (VMR) that is the capability of cerebral small vessels to respond to a stimulus
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start1 Oct 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 36 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
- NCT04577287
- Sponsor's protocol ID
- SI-2842019
- Status last verified
- Jul 2022
- First submitted
- 1 Oct 2020
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Anodal and Cathodal Transcranial Direct Current Stimulation Combined With Conventional Physical Therapy in Patients With Acute Stroke
- ClinicalTrials.gov ID
- NCT04577287
- Acronym / sponsor ID
- SI-2842019
- Conditions
- Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 6 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.
The objective of the study is thus to compare the effects 5 consecutive sessions of anodal and cathodal tDCS combined with conventional physical therapy on upper and lower limb motor performance in acute stroke at immediate, and 1-month followup.
Detailed description
Stroke is a major cause of long-term disability in stroke survivors that related with motor impairment. After stroke, the cortical excitability of ipsilesional hemisphere is decreased; in contrast, the cortical excitability of contralesional hemisphere is increased. Conventional physical therapy is beneficial to motor recovery, but early rehabilitation was not always help the patients get full recovery. tDCS is an adjuvant tools which deliver weak direct current through scalp to promote motor recovery in stroke rehabilitation. The anodal-tDCS increases cortical excitability, while the cathodal-tDCS decreases cortical excitability. Previous studies demonstrated that both monocephalic techniques of tDCS can improve motor function in chronic, subacute, and acute phase, but it is still inconclusive that which monocephalic montages had better effect, especially in acute phase. There are several studies supported the benefits of monocephalic tDCS combined with rehabilitation programs on upper and lower limbs motor function in acute stroke. However, there is no evidence that directly compared the effect of monocephalic tDCS in acute stroke patients. The objective of the study is to compare the effects of anodal and cathodal tDCS combined with conventional physical therapy for 5 sessions on motor performance in acute stroke at immediate, and 1-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cathodal tDCS & PT | Experimental | Device: Transcranial direct current stimulationCathodal transcranial direct current stimulation (tDCS) will be applied for 20 mins before conventional physical therapy (about 1 hour). Cathode on the on the motor area (M1) of the affected hemisphere, anode on the supraorbital area of the unaffect 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 cerebral hemodynamic . |
| 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). Anode on the motor are (M1) of the affected hemisphere, and 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 cerebral hemodynamic . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Acute ischemic stroke patients who have aged between 18 and 75 years
- Having a first ever-ischemic stroke that are confirmed by MRI/CT scan
- Post stroke onset 2-10 days
- Be able to follow command
- Be able to walk with or without assistive device (Modified Ranking Scale ≤ 4)
Key exclusion criteria (6 listed)
- Recurrent stroke
- National Institute of Health Stroke Scale ≥ 20 points
- Presence of intracranial metal implantation, cochlear implant, or cardiac pacemaker
- Having excessive pain in any joint of the lower limb (numerical pain rating score > 4/10)
- Having an open wound or wound infraction on 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 stimulationCathodal/Anodal 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, Cathodal tDCS & PT |
Primary outcome
Fugl-Meyer Assessment
Time frame: 20 minutes
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.
Wolf Motor Function Test
Time frame: 5 minutes
The participants will be asked to perform 2 items that consist of reaching a can and reaching a pen because two tasks is the most common reaching task of hand functions in daily living activities.
Five Times Sit to Stand Test
Time frame: 5 minutes
Subjects will sits on the chair and place their back against the chair. Timing will begin at "GO", the subjects will be asked to walk 3m, turn, walk back, and sit down. The stopwatch stops when the patient's buttocks touch the seat.
Time-up and go test
Time frame: 5 minutes
The TUG test is a commonly used screening tool to measure basic mobility correlating to dynamic balance. Start from sitting, stand up, walk 3 meters, turn around, walk back 3 meters and sit down. Timed to complete the task represent the body transfer and gait performance
Muscle strength
Time frame: 10 minutes
The strength of UE (shoulder flexor, shoulder extensor, elbow extensor, wrist extensor) and LE (hip extensor, hip flexor, knee extensor and ankle dorsiflexor) will be assessed by hand-held dynamometer
1 secondary outcome
Hemodynamic response (VMR%)
Time frame: 15 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 7 Jul 2022.
- Individual participant dataSharing planned: No
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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 6 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 7 Jul 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?
Fugl-Meyer Assessment (time frame: 20 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2022.