Transcranial Direct Current StimulationNCT04226417
Effect of Home Based Transcranial Direct Current Stimulation (tDCS) With Exercise on Upper and Lower Limb Motor Functions in Chronic Stroke
A study testing Transcranial direct current stimulation in people with Transcranial Direct Current Stimulation and Chronic Stroke, run by Mahidol University at 1 site in Thailand.
Trial summary
The aim of the present study is to investigate the effect of home based dual tDCS combined with exercise on upper and lower limb motor functions in chronic ischemic stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Transcranial Direct Current Stimulation, Chronic Stroke
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- 4 Oct 2019to 4 Jun 2020
- 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
- Aged between 18 and 75 years.
- First ischemic stroke.
- Stroke onset over 6 months to 5 years.
- Ability to communicate.
- Free of any neurological antecedent, unstable condition that may increase the risk of unsafe tDCS such as epilepsy.
- Unable to grasp normally (FMA-UE motor function on grasp score 0-1).
- Ability to walk 10 meters independently (with or without a mobility aid).
- Be able to follow the instruction.
Who cannot join
- Presence of intracranial metal implantation, cochlear implant, or cardiac pacemaker.
- Moderate pain in any joint of the lower limb (numerical pain rating score > 4/10).
- Open wound or wound infection on scalp.
- History of brain surgery.
- Musculoskeletal disorders affecting gait.
- Contracture or deformity of upper and lower extremity.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty ofPhysical Therapy, Mahidol University
Salaya, Nakonpathom, 73170
About this study
The aim of the present study is to investigate the effect of home based dual tDCS combined with exercise on upper and lower limb motor functions in chronic ischemic stroke patients.
Read the detailed description
Nowadays, stroke is the third cause of death in developing countries after coronary heart disease and cancer. Worldwide, 3 million women and 2.5 million men were killed by the stroke every year. In Thailand, stroke is the first leading cause of death. In every 2 minutes, Thai population have occurred at least one new stroke case.
Over six months after stroke onset or chronic phase, long-term disability occurred when patients did not continuously receive appropriate intervention. Motor disability is the most limiting factor influencing activities in daily life, such as upper and lower limb motor functions, and gait disturbance, which could in turn leading to long-term disability. Especially, affected arm remains malfunction in half of chronic stroke patients. The multidisciplinary rehabilitation has been provided for chronic stroke patients to reduce burden of caregivers and to improve patients' well-being. Besides, many patients with chronic stroke who live in community could not access the hospital or health care center because of inconvenient transportation as well as limited support by the family.
It past twenty years, transcranial direct current stimulation (tDCS) has been introduced as is non-invasive brain stimulation (NIBS) that can use in rehabilitation. There are several studies shown that tDCS can change cortical excitability in the brain and consider as an additional therapy to improve motor function in stroke patients. Moreover, the tDCS is portable, cost effective, safety to use and can be self-administered might benefit for patients in residence. In fact, imbalance of interhemispheric inhibition (IHI) occurred after stroke by neuronal excitability decreased in the lesioned hemisphere and increased in the non-lesioned hemisphere. The tDCS delivered weak direct current via two electrodes as anodal and cathodal. The effect of cathodal electrode can decrease excitability and increase excitability by anodal electrode. Furthermore, both electrodes were applied on the two hemisphere in the same period for expect the results of two electrode called dual tDCS.
Current evidence indicated that the 4-week anodal tDCS combined transcranial direct current stimulation (tDCS) with robotic training could improve motor function in chronic stroke patients. Nevertheless, this intervention program is a hospital-based intervention, which would limit the generalization to patients who live in community. Previous study showed that 4-week anodal tDCS combined with exercise could improve upper and lower limb motor functions in chronic stroke patients. However, there is no evidence indicate that 4-week home-based tDCS combined with exercise have been improved upper and lower limb motor functions in chronic stroke patients in residence.
- Being tested
- Transcranial direct current stimulation
- Keywords
- transcranial direct current stimulation, motor function, exercise, chronic stroke
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Dual/ Sham tDCS will be applied in 2 mA, 20 mins before the home-based exercise program in 3 times per week for 4 weeks (12 sessions)
| Study group | Role | What they receive |
|---|---|---|
| Dual-tDCS & home program exercise | Active comparator | Dual transcranial direct current stimulation (tDCS) will be applied over C3-C4 by using a reference to the international 10-20 electrode placement system for EEG electrode placement. The current intensity will be 2 mA, delivered for 20 minutes before the home-based exercise program by themselves and/or caregiver. Anodal electrode will be applied over the M1 of the affected hemisphere, while the cathodal electrode will be applied over the M1 of the non-lesioned. In all sessions of intervention at participant's resident, the investigator will supervise the processes of setting tDCS and exercise in all sessions (total 12 sessions, 3 days per week for 4 weeks). Receives: Device: Transcranial direct current stimulation |
| Sham-tDCS & home program exercise | Sham comparator | Sham transcranial direct current stimulation (tDCS) will be applied over C3-C4 by using a reference to the international 10-20 electrode placement system for EEG electrode placement. The current intensity will be 2 mA, delivered only 30 seconds before the home-based exercise program by themselves and/or caregiver. Anodal electrode will be applied over the M1 of the affected hemisphere, while the cathodal electrode will be applied over the M1 of the non-lesioned. In all sessions of intervention at participant's resident, the investigator will supervise the processes of setting tDCS and exercise in all sessions (total 12 sessions, 3 days per week for 4 weeks). 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 in upper & lower limbs
The assessment of motor function both upper and lower limbs, this study will measure only motor function domain from 5 domains includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, hand, hip, knee, and ankle. The 100 totally score divided into 66 points for upper limb and 34 points for lower limb.
Measured: 20 minutes
Wolf Motor Function Test
This assessment quantifies upper limb motor ability through timed and functional tasks consists of 17 items. The scoring rated on a 6 points scale.
Measured: 20 minutes
Secondary outcomes (4)
Five-times Sit to Stand Test
The five times sit to stand measure of functional lower limb muscle strength that quantifying functional change of transitional movement. Participants were asked to stand up and sit down as quickly as possible 5 times and keeping their arms folded across your chest. The researcher stop timing when the participant stands the 5th time.
Measured: 5 minutes
6-Meter Walk Test
The assessment of walking speed in meters per second over short distance. The participants will be asked to walk 2 trials with comfortable speed for 10 meters. The researcher will time middle 6 meters.
Measured: 5 minutes
Timed Up and Go Test
The assessment of functional mobility, balance, walking ability. The participants will be asked to walk with comfortable speed 3 meters, turn around the cone, walk back to the chair and sit down. The researcher will stop timing when the participant's buttocks touch the seat.
Measured: 5 minutes
Muscle strength
The handheld dynamometer will be used to measure muscle strength. Participants will perform the action of muscle against the resistance 2 trials per muscle. The researcher will measure muscle strength of upper and lower limbs including wrist extensor, elbow extensor, ankle dorsiflexor, knee extensor, hip flexor, and hip extensor.
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 posted13 Jan 2020
- Study start4 Oct 2019
- Primary completion12 Apr 2020
- Study completion4 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Direct Current StimulationStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226417
- Sponsor's protocol ID
- MU-CIRB 2019/063.2102
- Status last verified
- Jun 2020
- First submitted
- 9 Jan 2020
- Last updated
- 16 Jun 2020
- Results posted
- 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 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Home Based Transcranial Direct Current Stimulation (tDCS) With Exercise on Upper and Lower Limb Motor Functions in Chronic Stroke
- ClinicalTrials.gov ID
- NCT04226417
- Acronym / sponsor ID
- MU-CIRB 2019/063.2102
- Keywords
- transcranial direct current stimulation, motor function, exercise, chronic stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 12 Apr 2020 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 13 Jan 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 aim of the present study is to investigate the effect of home based dual tDCS combined with exercise on upper and lower limb motor functions in chronic ischemic stroke patients.
Detailed description
Nowadays, stroke is the third cause of death in developing countries after coronary heart disease and cancer. Worldwide, 3 million women and 2.5 million men were killed by the stroke every year. In Thailand, stroke is the first leading cause of death. In every 2 minutes, Thai population have occurred at least one new stroke case.
Over six months after stroke onset or chronic phase, long-term disability occurred when patients did not continuously receive appropriate intervention. Motor disability is the most limiting factor influencing activities in daily life, such as upper and lower limb motor functions, and gait disturbance, which could in turn leading to long-term disability. Especially, affected arm remains malfunction in half of chronic stroke patients. The multidisciplinary rehabilitation has been provided for chronic stroke patients to reduce burden of caregivers and to improve patients' well-being. Besides, many patients with chronic stroke who live in community could not access the hospital or health care center because of inconvenient transportation as well as limited support by the family.
It past twenty years, transcranial direct current stimulation (tDCS) has been introduced as is non-invasive brain stimulation (NIBS) that can use in rehabilitation. There are several studies shown that tDCS can change cortical excitability in the brain and consider as an additional therapy to improve motor function in stroke patients. Moreover, the tDCS is portable, cost effective, safety to use and can be self-administered might benefit for patients in residence. In fact, imbalance of interhemispheric inhibition (IHI) occurred after stroke by neuronal excitability decreased in the lesioned hemisphere and increased in the non-lesioned hemisphere. The tDCS delivered weak direct current via two electrodes as anodal and cathodal. The effect of cathodal electrode can decrease excitability and increase excitability by anodal electrode. Furthermore, both electrodes were applied on the two hemisphere in the same period for expect the results of two electrode called dual tDCS.
Current evidence indicated that the 4-week anodal tDCS combined transcranial direct current stimulation (tDCS) with robotic training could improve motor function in chronic stroke patients. Nevertheless, this intervention program is a hospital-based intervention, which would limit the generalization to patients who live in community. Previous study showed that 4-week anodal tDCS combined with exercise could improve upper and lower limb motor functions in chronic stroke patients. However, there is no evidence indicate that 4-week home-based tDCS combined with exercise have been improved upper and lower limb motor functions in chronic stroke patients in residence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual-tDCS & home program exercise | Active comparator | Device: Transcranial direct current stimulationDual transcranial direct current stimulation (tDCS) will be applied over C3-C4 by using a reference to the international 10-20 electrode placement system for EEG electrode placement. The current intensity will be 2 mA, delivered for 20 minutes before the home-based exercise program by themselves and/or caregiver. Anodal electrode will be applied over the M1 of the affected hemisphere, while the cathodal electrode will be applied over the M1 of the non-lesioned. In all sessions of intervention at participant's resident, the investigator will supervise the processes of setting tDCS and exercise in all sessions (total 12 sessions, 3 days per week for 4 weeks). |
| Sham-tDCS & home program exercise | Sham comparator | Device: Transcranial direct current stimulationSham transcranial direct current stimulation (tDCS) will be applied over C3-C4 by using a reference to the international 10-20 electrode placement system for EEG electrode placement. The current intensity will be 2 mA, delivered only 30 seconds before the home-based exercise program by themselves and/or caregiver. Anodal electrode will be applied over the M1 of the affected hemisphere, while the cathodal electrode will be applied over the M1 of the non-lesioned. In all sessions of intervention at participant's resident, the investigator will supervise the processes of setting tDCS and exercise in all sessions (total 12 sessions, 3 days per week for 4 weeks). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged between 18 and 75 years.
- First ischemic stroke.
- Stroke onset over 6 months to 5 years.
- Ability to communicate.
- Free of any neurological antecedent, unstable condition that may increase the risk of unsafe tDCS such as epilepsy.
Key exclusion criteria (6 listed)
- Presence of intracranial metal implantation, cochlear implant, or cardiac pacemaker.
- Moderate pain in any joint of the lower limb (numerical pain rating score > 4/10).
- Open wound or wound infection on scalp.
- History of brain surgery.
- Musculoskeletal disorders affecting gait.
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 stimulationDual/ Sham tDCS will be applied in 2 mA, 20 mins before the home-based exercise program in 3 times per week for 4 weeks (12 sessions) | Device | Dual-tDCS & home program exercise, Sham-tDCS & home program exercise |
Primary outcome
Fugl-Meyer Assessment in upper & lower limbs
Time frame: 20 minutes
The assessment of motor function both upper and lower limbs, this study will measure only motor function domain from 5 domains includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, hand, hip, knee, and ankle. The 100 totally score divided into 66 points for upper limb and 34 points for lower limb.
Wolf Motor Function Test
Time frame: 20 minutes
This assessment quantifies upper limb motor ability through timed and functional tasks consists of 17 items. The scoring rated on a 6 points scale.
4 secondary outcomes
Five-times Sit to Stand Test
Time frame: 5 minutes
6-Meter Walk Test
Time frame: 5 minutes
Timed Up and Go Test
Time frame: 5 minutes
Muscle strength
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 16 Jun 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Transcranial Direct Current Stimulation and Chronic Stroke, 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 8 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 16 Jun 2020. 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. Some participants in this study may receive a placebo. 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 in upper & lower limbs (time frame: 20 minutes). The study lists 2 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 16 Jun 2020.