StrokeNCT03486769
Dual Site-dual Channel Non-invasive Brain Stimulation for Motor Function in Stroke Patients
A study testing M1 stimulation, PMC stimulation and aIPS stimulation in people with Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of motor function in post stroke patients. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- M1 stimulation, PMC stimulation and aIPS stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 May 2018to 17 Mar 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral hemiplegic stroke patient
- Fugl Meyer Assessment score between 9 to 84
Who cannot join
- difficult to understand experimental tasks because of extremely severe cognitive impairment
- history of psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dual Site-dual Channel Non-invasive Brain Stimulation for Recovery of Motor Function in Stroke Patients
The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of motor function in post stroke patients. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. All subjects will go through three conditions of transcranial direct current stimulation with for 30 minutes. Three conditions are 1) Dual stimulation 1: i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional premotor cortex and cathodal stimulation on contralesional supraorbital area. 2) Dual stimulation 2: i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional anterior intraparietal sulcus and cathodal stimulation on contralesional supraorbital area. 3) Single stimulation: anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex.
- Conditions
- Stroke
- Being tested
- M1 stimulation, PMC stimulation, aIPS stimulation, hand motor task
- Keywords
- transcranial direct current stimulation, dual stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M1 stimulationDevice
Also called primary motor cortex anodal stimulation
stimulating primary motor cortex with anodal transcranial direct current stimulation
PMC stimulationDevice
Also called premotor cortex anodal stimulation
stimulating premotor cortex with anodal transcranial direct current stimulation
aIPS stimulationDevice
stimulating anterior intraparietal sulcus with anodal transcranial direct current stimulation
hand motor taskBehavioural
hand motor task for 30 minutes during transcranial direct current stimulation
| Study group | Role | What they receive |
|---|---|---|
| Dual Stimulation 1 | Experimental | i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional premotor cortex and cathodal stimulation on contralesional supraorbital area. Receives: Device: M1 stimulation; Device: PMC stimulation; Behavioral: hand motor task |
| Dual Stimulation 2 | Experimental | i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional anterior intraparietal sulcus and cathodal stimulation on contralesional supraorbital area. Receives: Device: M1 stimulation; Device: aIPS stimulation; Behavioral: hand motor task |
| Single stimulation | Experimental | anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex Receives: Device: M1 stimulation; Behavioral: hand motor task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in motor evoked potentia
measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle.
Measured: Baseline and after intervention (approximately 2 weeks)
Secondary outcomes (5)
changes in nine hole peg test
Nine-Hole Peg Test is used to measure finger dexterity in patients with various neurological diagnoses.
Measured: Baseline and after intervention (approximately 2 weeks)
changes in grip and tip pinch strength test
measure the hand strength (grip and tip pinch)
Measured: Baseline and after intervention (approximately 2 weeks)
changes in box and block test
box and block test measures unilateral gross manual dexterity
Measured: Baseline and after intervention (approximately 2 weeks)
Changes in brain activation of resting-state functional MRI
Neuroplasticity measure
Measured: Baseline and after intervention (approximately 2 weeks)
Changes of Cortical activation
Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany)
Measured: Baseline and after intervention (approximately 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start23 May 2018
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486769
- Sponsor's protocol ID
- 2017-08-124-A
- Status last verified
- Mar 2020
- First submitted
- 22 Mar 2018
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dual Site-dual Channel Non-invasive Brain Stimulation for Recovery of Motor Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT03486769
- Acronym / sponsor ID
- 2017-08-124-A
- Conditions
- Stroke
- Keywords
- transcranial direct current stimulation, dual stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 23 May 2018 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 3 Apr 2018 (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 this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of motor function in post stroke patients. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. All subjects will go through three conditions of transcranial direct current stimulation with for 30 minutes. Three conditions are 1) Dual stimulation 1: i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional premotor cortex and cathodal stimulation on contralesional supraorbital area. 2) Dual stimulation 2: i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional anterior intraparietal sulcus and cathodal stimulation on contralesional supraorbital area. 3) Single stimulation: anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dual Stimulation 1 | Experimental | Device: M1 stimulation, Device: PMC stimulation, Behavioral: hand motor taski) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional premotor cortex and cathodal stimulation on contralesional supraorbital area. |
| Dual Stimulation 2 | Experimental | Device: M1 stimulation, Device: aIPS stimulation, Behavioral: hand motor taski) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional anterior intraparietal sulcus and cathodal stimulation on contralesional supraorbital area. |
| Single stimulation | Experimental | Device: M1 stimulation, Behavioral: hand motor taskanodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- unilateral hemiplegic stroke patient
- Fugl Meyer Assessment score between 9 to 84
Key exclusion criteria (2 listed)
- difficult to understand experimental tasks because of extremely severe cognitive impairment
- history of psychiatric disease
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 |
|---|---|---|
| M1 stimulationAlso: primary motor cortex anodal stimulationstimulating primary motor cortex with anodal transcranial direct current stimulation | Device | Dual Stimulation 1, Dual Stimulation 2, Single stimulation |
| PMC stimulationAlso: premotor cortex anodal stimulationstimulating premotor cortex with anodal transcranial direct current stimulation | Device | Dual Stimulation 1 |
| aIPS stimulationstimulating anterior intraparietal sulcus with anodal transcranial direct current stimulation | Device | Dual Stimulation 2 |
| hand motor taskhand motor task for 30 minutes during transcranial direct current stimulation | Behavioural | Dual Stimulation 1, Dual Stimulation 2, Single stimulation |
Primary outcome
Changes in motor evoked potentia
Time frame: Baseline and after intervention (approximately 2 weeks)
measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle.
5 secondary outcomes
changes in nine hole peg test
Time frame: Baseline and after intervention (approximately 2 weeks)
changes in grip and tip pinch strength test
Time frame: Baseline and after intervention (approximately 2 weeks)
changes in box and block test
Time frame: Baseline and after intervention (approximately 2 weeks)
Changes in brain activation of resting-state functional MRI
Time frame: Baseline and after intervention (approximately 2 weeks)
Changes of Cortical activation
Time frame: Baseline and after intervention (approximately 2 weeks)
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 27 May 2020.
- Individual participant dataSharing planned: Undecided
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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 M1 stimulation, PMC stimulation and aIPS stimulation in people with Stroke, run by Samsung Medical Center at 1 site in South Korea.
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 2 inclusion and 2 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 27 May 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 South Korea. 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?
Changes in motor evoked potentia (time frame: Baseline and after intervention (approximately 2 weeks)). 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 27 May 2020.