StrokeNCT03035162
Dual-hemisphere Transcranial Direct Current Stimulation on Lower Limb Motor Functions After Stroke
A study testing Transcranial direct current stimulation in people with Stroke, run by Mahidol University at 1 site in Thailand.
Trial summary
The aim of the present study is to evaluate the possible effect of using dual-tDCS combined with conventional physical therapy on lower limb function in stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- 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
- 19 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2017to Aug 2018
- 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 range 18-75 years.
- First ever-ischemic lesion in the territory of middle cerebral artery or anterior cerebral artery. CT scan/MRI result is thus required.
- Sub acute phase of stroke (less than 6 months)
- Able to sit-to-stand and stand-to-sit independently
- Able to walk without physical assistance at least 6 m
- Free of any neurological antecedent, unstable medical conditions or condition that may increase the risk of stimulation such as epilepsy; although tDCS is believed to induce less or no risk of seizure and epileptic seizure have never been reported in tDCS study even in a study with active epilepsy (Fregni et al., 2006).
Who cannot join
- Pre-stroke disability
- Pregnant
- Be unable to understand the instruction
- No clear neurological antecedent history or psychiatric disorder
- Excessive pain in any joint of the paretic limb (numerical pain rating score > 7)
- Presence of intracranial metal implantation, cochlea implant, or cardiac pacemaker
- Subjects are participating in the other protocol or receiving alternative treatment such as acupuncture
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 evaluate the possible effect of using dual-tDCS combined with conventional physical therapy on lower limb function in stroke patients.
Read the detailed description
Stroke is a leading cause of adult motor disability. The recovery of motor function after stroke is often incomplete, despite classical rehabilitation techniques. In the beginning of the 21th century, transcranial direct current stimulation (tDCS) was introduced as a non-invasive tool to reversibly modulate brain excitability in humans in which a device sends constant low direct current (DC) delivered to the area of interest through the electrodes. These findings have opened the way to the therapeutic use of the brain stimulation for stroke. Based on the polarity-specific effects, anodal tDCS increases cortical excitability and cathodal tDCS decreases cortical excitability. To change the cortical excitability, tDCS differs from other brain stimulation techniques such as transcranial magnetic stimulation (TMS) in that it does not cause action potentials in cortical neurons, but rather induces shifts in neuronal resting membrane potential . This is considered to induce a lesser or no risk of a seizure. Given its advantages such as non-invasiveness, painlessness, safety, and possible after-effects, tDCS rapidly become a therapeutic adjuvant in neurorehabilitation especially in stroke patients with motor deficits . A number of studies in healthy subjects and stroke patients have reported that tDCS-induced excitability changes are related to increase in the performance of motor tasks and motor skills learning, mainly upper limb functions Recenty, dual-hemisphere tDCS in which, excites one hemisphere using anodal stimulation and inhibits the other by cathodal stimulation has been described in healthy subjects to greater enhance hand motor learning compared to uni-hemisphere tDCS. The corresponding tDCS-induced changes were reported in imaging study to involve interhemispheric interactions . An increase in the excitability of unaffected hemisphere and an abnormally high interhemispheric inhibition (IHI) drive from intact to lesioned hemisphere have been widely reported after unilateral stroke. Dual-tDCS has been more recent used in rehabilitation aiming to reduce the inhibition exerted by the unaffected hemisphere on the affected hemisphere and restore the normal balance of the IHI. Dual-tDCS combined with training or simultaneous occupational/physical therapy has been reported to improve motor skill learning and functions of the paretic upper limb in chronic stroke patients .
Lower-limb functions are commonly disordered after stoke, however, less study has focused the effect of tDCS on lower limb functions. A single session of anodal tDCS over the lower limb M1 has reported to acutely enhance the effect of motor practice of the paretic ankle, force production of the paretic knee extensors, and postural stability in chronic stroke patients. However, little is known about effects of dual-tDCS on lower limb in stroke patients. Only one recent study showed an improvement of walking speed immediately after a single session of dual-tDCS alone in sub-acute stroke patients .
- Conditions
- Stroke
- Being tested
- Transcranial direct current stimulation
- Keywords
- dual tDCS, physical rehabilitation, lower limb functions
- 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
Dual Active/sham tDCS will be applied over the leg motor area (M1) priori to conventional physical therapy (1 hours). Anodal on affected hemisphere, Cathodal on unaffected hemisphere. Each participant will complete two experiments (active/sham tDCS). The interval between two experiments is at least 48 hours. The two experiments will be performed in random order for each subject.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS & PT | Experimental | Dual transcranial direct current stimulation (tDCS) will be applied over the leg motor area (M1) priori to conventional physical therapy (1 hours). Anodal on affected hemisphere, Cathodal on unaffected hemisphere. Current intensity is fixed at 2 mA and current will flow continuously during 20 minutes for the active conditions. Physical therapist will give an intervention program exactly the same in all cases. The scope of intervention is administered to improve strength of weakened and postural lower limbs muscles such as trunk muscles, hip flexors/extensors/abductors, knee flexors/extensors. Receives: Device: Transcranial direct current stimulation |
| Sham tDCS & PT | Active comparator | Dual transcranial direct current stimulation (tDCS) will be applied over the leg motor area (M1) priori to conventional physical therapy (1 hours). Anodal on affected hemisphere, Cathodal on unaffected hemisphere. Current intensity is fixed at 2 mA and current will flow only 2 minutes for the sham conditions. Physical therapist will give an intervention program exactly the same in all cases. The scope of intervention is administered to improve strength of weakened and postural lower limbs muscles such as trunk muscles, hip flexors/extensors/abductors, knee flexors/extensors. Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength
Knee extensors strength is required to perform lower functions including sit-to-stand and gait. Knee extensor strength will measure using Biodex system, performing while the subjects comfortably seat in the position of knee flexed at 120° and ankle at 110° of plantar flexion on the attached footplate. Subjects will perform 3 isometric maximum voluntary contraction (MVC) of the knee extensor during a duration of 5 sec, separated by 2 min rest. The highest MVC in each session will be used as MVC level.
Measured: 15 minutes
Five-Times-Sit-To-Stand test (FTSST)
Subject will sits with arms folded across chest or the paretic arm at the side or in a sling. Subjects will be instructed as the following "I want you to stand up and sit down 5 times as quickly as you can when I say 'Go'." Subjects must be fully standing between repetitions. Timing will begin at "GO" and ends when the patient's buttocks touch the seat after the fifth sit-to-stand.
Measured: 5 minutes
Timed Up & Go test (TUG)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2017
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wanalee Klomjai, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035162
- Sponsor's protocol ID
- MU-CIRB 2016/048.0704
- Status last verified
- Aug 2018
- First submitted
- 25 Jan 2017
- Last updated
- 17 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cabral ME, Baltar A, Borba R, Galvao S, Santos L, Fregni F, Monte-Silva K. Transcranial direct current stimulation: before, during, or after motor training? Neuroreport. 2015 Aug 5;26(11):618-22. doi: 10.1097/WNR.0000000000000397.
PubMed 26049257Fregni F, Thome-Souza S, Nitsche MA, Freedman SD, Valente KD, Pascual-Leone A. A controlled clinical trial of cathodal DC polarization in patients with refractory epilepsy. Epilepsia. 2006 Feb;47(2):335-42. doi: 10.1111/j.1528-1167.2006.00426.x.
PubMed 16499758Jeffery DT, Norton JA, Roy FD, Gorassini MA. Effects of transcranial direct current stimulation on the excitability of the leg motor cortex. Exp Brain Res. 2007 Sep;182(2):281-7. doi: 10.1007/s00221-007-1093-y. Epub 2007 Aug 24.
PubMed 17717651Kim CR, Kim DY, Kim LS, Chun MH, Kim SJ, Park CH. Modulation of cortical activity after anodal transcranial direct current stimulation of the lower limb motor cortex: a functional MRI study. Brain Stimul. 2012 Oct;5(4):462-7. doi: 10.1016/j.brs.2011.08.002. Epub 2011 Aug 26.
PubMed 21962977Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
PubMed 10990547Roche N, Lackmy A, Achache V, Bussel B, Katz R. Effects of anodal transcranial direct current stimulation over the leg motor area on lumbar spinal network excitability in healthy subjects. J Physiol. 2011 Jun 1;589(Pt 11):2813-26. doi: 10.1113/jphysiol.2011.205161. Epub 2011 Apr 18.
PubMed 21502292Roche N, Lackmy A, Achache V, Bussel B, Katz R. Effects of anodal tDCS on lumbar propriospinal system in healthy subjects. Clin Neurophysiol. 2012 May;123(5):1027-34. doi: 10.1016/j.clinph.2011.09.011. Epub 2011 Oct 20.
PubMed 22014699
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-hemisphere Transcranial Direct Current Stimulation on Lower Limb Motor Functions After Stroke
- ClinicalTrials.gov ID
- NCT03035162
- Acronym / sponsor ID
- MU-CIRB 2016/048.0704
- Conditions
- Stroke
- Keywords
- dual tDCS, physical rehabilitation, lower limb functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 27 Jan 2017 (estimated)
- 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 evaluate the possible effect of using dual-tDCS combined with conventional physical therapy on lower limb function in stroke patients.
Detailed description
Stroke is a leading cause of adult motor disability. The recovery of motor function after stroke is often incomplete, despite classical rehabilitation techniques. In the beginning of the 21th century, transcranial direct current stimulation (tDCS) was introduced as a non-invasive tool to reversibly modulate brain excitability in humans in which a device sends constant low direct current (DC) delivered to the area of interest through the electrodes. These findings have opened the way to the therapeutic use of the brain stimulation for stroke. Based on the polarity-specific effects, anodal tDCS increases cortical excitability and cathodal tDCS decreases cortical excitability. To change the cortical excitability, tDCS differs from other brain stimulation techniques such as transcranial magnetic stimulation (TMS) in that it does not cause action potentials in cortical neurons, but rather induces shifts in neuronal resting membrane potential . This is considered to induce a lesser or no risk of a seizure. Given its advantages such as non-invasiveness, painlessness, safety, and possible after-effects, tDCS rapidly become a therapeutic adjuvant in neurorehabilitation especially in stroke patients with motor deficits . A number of studies in healthy subjects and stroke patients have reported that tDCS-induced excitability changes are related to increase in the performance of motor tasks and motor skills learning, mainly upper limb functions Recenty, dual-hemisphere tDCS in which, excites one hemisphere using anodal stimulation and inhibits the other by cathodal stimulation has been described in healthy subjects to greater enhance hand motor learning compared to uni-hemisphere tDCS. The corresponding tDCS-induced changes were reported in imaging study to involve interhemispheric interactions . An increase in the excitability of unaffected hemisphere and an abnormally high interhemispheric inhibition (IHI) drive from intact to lesioned hemisphere have been widely reported after unilateral stroke. Dual-tDCS has been more recent used in rehabilitation aiming to reduce the inhibition exerted by the unaffected hemisphere on the affected hemisphere and restore the normal balance of the IHI. Dual-tDCS combined with training or simultaneous occupational/physical therapy has been reported to improve motor skill learning and functions of the paretic upper limb in chronic stroke patients .
Lower-limb functions are commonly disordered after stoke, however, less study has focused the effect of tDCS on lower limb functions. A single session of anodal tDCS over the lower limb M1 has reported to acutely enhance the effect of motor practice of the paretic ankle, force production of the paretic knee extensors, and postural stability in chronic stroke patients. However, little is known about effects of dual-tDCS on lower limb in stroke patients. Only one recent study showed an improvement of walking speed immediately after a single session of dual-tDCS alone in sub-acute stroke patients .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS & PT | Experimental | Device: Transcranial direct current stimulationDual transcranial direct current stimulation (tDCS) will be applied over the leg motor area (M1) priori to conventional physical therapy (1 hours). Anodal on affected hemisphere, Cathodal on unaffected hemisphere. Current intensity is fixed at 2 mA and current will flow continuously during 20 minutes for the active conditions. Physical therapist will give an intervention program exactly the same in all cases. The scope of intervention is administered to improve strength of weakened and postural lower limbs muscles such as trunk muscles, hip flexors/extensors/abductors, knee flexors/extensors. |
| Sham tDCS & PT | Active comparator | Device: Transcranial direct current stimulationDual transcranial direct current stimulation (tDCS) will be applied over the leg motor area (M1) priori to conventional physical therapy (1 hours). Anodal on affected hemisphere, Cathodal on unaffected hemisphere. Current intensity is fixed at 2 mA and current will flow only 2 minutes for the sham conditions. Physical therapist will give an intervention program exactly the same in all cases. The scope of intervention is administered to improve strength of weakened and postural lower limbs muscles such as trunk muscles, hip flexors/extensors/abductors, knee flexors/extensors. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age range 18-75 years.
- First ever-ischemic lesion in the territory of middle cerebral artery or anterior cerebral artery. CT scan/MRI result is thus required.
- Sub acute phase of stroke (less than 6 months)
- Able to sit-to-stand and stand-to-sit independently
- Able to walk without physical assistance at least 6 m
Key exclusion criteria (7 listed)
- Pre-stroke disability
- Pregnant
- Be unable to understand the instruction
- No clear neurological antecedent history or psychiatric disorder
- Excessive pain in any joint of the paretic limb (numerical pain rating score > 7)
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 Active/sham tDCS will be applied over the leg motor area (M1) priori to conventional physical therapy (1 hours). Anodal on affected hemisphere, Cathodal on unaffected hemisphere. Each participant will complete two experiments (active/sham tDCS). The interval between two experiments is at least 48 hours. The two experiments will be performed in random order for each subject. | Device | Active tDCS & PT, Sham tDCS & PT |
Primary outcome
Strength
Time frame: 15 minutes
Knee extensors strength is required to perform lower functions including sit-to-stand and gait. Knee extensor strength will measure using Biodex system, performing while the subjects comfortably seat in the position of knee flexed at 120° and ankle at 110° of plantar flexion on the attached footplate. Subjects will perform 3 isometric maximum voluntary contraction (MVC) of the knee extensor during a duration of 5 sec, separated by 2 min rest. The highest MVC in each session will be used as MVC level.
Five-Times-Sit-To-Stand test (FTSST)
Time frame: 5 minutes
Subject will sits with arms folded across chest or the paretic arm at the side or in a sling. Subjects will be instructed as the following "I want you to stand up and sit down 5 times as quickly as you can when I say 'Go'." Subjects must be fully standing between repetitions. Timing will begin at "GO" and ends when the patient's buttocks touch the seat after the fifth sit-to-stand.
Timed Up & Go test (TUG)
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.
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 17 Aug 2018.
- Background: PubMed 26049257Cabral ME, Baltar A, Borba R, Galvao S, Santos L, Fregni F, Monte-Silva K. Transcranial direct current stimulation: before, during, or after motor training? Neuroreport. 2015 Aug 5;26(11):618-22. doi: 10.1097/WNR.0000000000000397.
- Background: PubMed 16499758Fregni F, Thome-Souza S, Nitsche MA, Freedman SD, Valente KD, Pascual-Leone A. A controlled clinical trial of cathodal DC polarization in patients with refractory epilepsy. Epilepsia. 2006 Feb;47(2):335-42. doi: 10.1111/j.1528-1167.2006.00426.x.
- Background: PubMed 17717651Jeffery DT, Norton JA, Roy FD, Gorassini MA. Effects of transcranial direct current stimulation on the excitability of the leg motor cortex. Exp Brain Res. 2007 Sep;182(2):281-7. doi: 10.1007/s00221-007-1093-y. Epub 2007 Aug 24.
- Background: PubMed 21962977Kim CR, Kim DY, Kim LS, Chun MH, Kim SJ, Park CH. Modulation of cortical activity after anodal transcranial direct current stimulation of the lower limb motor cortex: a functional MRI study. Brain Stimul. 2012 Oct;5(4):462-7. doi: 10.1016/j.brs.2011.08.002. Epub 2011 Aug 26.
- Background: PubMed 10990547Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
- Background: PubMed 21502292Roche N, Lackmy A, Achache V, Bussel B, Katz R. Effects of anodal transcranial direct current stimulation over the leg motor area on lumbar spinal network excitability in healthy subjects. J Physiol. 2011 Jun 1;589(Pt 11):2813-26. doi: 10.1113/jphysiol.2011.205161. Epub 2011 Apr 18.
- Background: PubMed 22014699Roche N, Lackmy A, Achache V, Bussel B, Katz R. Effects of anodal tDCS on lumbar propriospinal system in healthy subjects. Clin Neurophysiol. 2012 May;123(5):1027-34. doi: 10.1016/j.clinph.2011.09.011. Epub 2011 Oct 20.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
RecruitingObservational study
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, 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.
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 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 6 inclusion and 7 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 17 Aug 2018. 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?
Strength (time frame: 15 minutes). The study lists 3 primary outcomes in all. 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 NCT03035162, which also lists 7 linked publications.
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 17 Aug 2018.