StrokeNCT02987361
Effect of tDCS on Upper Extremity After Strokes
A study testing DC-STIMULATOR PLUS in people with Stroke, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
The investigators hypothesize that transcranial direct current stimulation (tDCS) can improve upper limb motor recovery in the sub-acute phase of stroke patients. This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- DC-STIMULATOR PLUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2016to 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-85
- Unilateral Stroke patients
- Inclusion must be in the sub-acute phase defined as within 48hr-4 weeks after stroke
- Patients who have evoked motor potentials on the first dorsal interossei muscles on hemiplegic hand
- The patient has subscribed the informed consent
Who cannot join
- Insert a metal object on the head
- Convulsive disorders
- History of brain diseases other than stroke
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kim Yeon Hee
Seoul, Ilwon, 06355
AH HE LEE, MS, 82-2-6007-5408, ahee.lee@gmail.com
About this study
Official title: Effects of Transcranial Direct Current Stimulation on Hemiplegic Upper Extremity Function After Strokes
The investigators hypothesize that transcranial direct current stimulation (tDCS) can improve upper limb motor recovery in the sub-acute phase of stroke patients.
This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.
Read the detailed description
The investigators hypothesize that transcranial direct current stimulation (tDCS) can improve upper limb motor recovery in the sub-acute phase of stroke patients.
This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.
Informed consent was obtained from all participants and procedures were conducted according to the Declaration of Helsinki. The protocol was approved by the Chonbuk National Uni. Hospital IRB, KOREA.
Seventy-two stroke patients in the sub-acute phase will be recruited in three centers of neurorehabilitation in republic of Korea.
Patients will be randomly divided to four groups; group1 is anodal stimulation on the lesioned primary motor cortex, group 2 is cathodal stimulation on the non-lesioned primary motor cortex, group 3 is dual stimulation such as anodal stimulation on the lesioned side and cathod stimulation on the non-lesioned side, and group 4 is shame stimulation group.
The stimulation will be conducted 2mA for 20 minute a day, 5 days per weeks, totally 2 weeks.
Fugl-Meyer upper motor score will be measured as a primary outcome.
- Conditions
- Stroke
- Being tested
- DC-STIMULATOR PLUS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC-STIMULATOR PLUSDevice
Also called tDCS
2mA for 20minutes a day, 5 days per weeks, totally 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| treatment group 1 | Experimental | anodal stimulation on the lesioned primary motor cortex DC-STIMULATOR PLUS Receives: Device: DC-STIMULATOR PLUS |
| treatment group 2 | Experimental | cathodal stimulation on the non-lesioned primary motor cortex DC-STIMULATOR PLUS Receives: Device: DC-STIMULATOR PLUS |
| treatment group 3 | Experimental | dual stimulation such as anodal stimulation on the lesioned side and cathodal stimulation on the non-lesioned side DC-STIMULATOR PLUS Receives: Device: DC-STIMULATOR PLUS |
| sham group | Sham comparator | sham group Receives: Device: DC-STIMULATOR PLUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Upper Motor Score change
Measured: before treatment, 48 hours after treatment, 4 weeks after treatment
Secondary outcomes (3)
Manual Muscle Test (MMT) change
Measured: before treatment, 48 hours after treatment, 4 weeks after treatment
Range of Motion (ROM) change
Measured: before treatment, 48 hours after treatment, 4 weeks after treatment
Korean version Modified Bathel Index (KMBI) change
Measured: before treatment, 48 hours after treatment, 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2016
- Study completionAug 2018 (estimated)
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.
- 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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center, Pusan National University Yangsan Hospital
- Responsible party
- Principal investigator, Myoung Hwan Ko, Chonbuk National University Hospital
- Investigators
- Myoung Hwan Ko, MD, PhD, Principal investigator, 634-18, Geumam-dong, Deokjin-gu, Jeonju, Jeonbuk, 561-712 Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987361
- Sponsor's protocol ID
- CBNUH_MDCTC_2015_tDCS
- Status last verified
- Dec 2016
- First submitted
- 31 Aug 2016
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation on Hemiplegic Upper Extremity Function After Strokes
- ClinicalTrials.gov ID
- NCT02987361
- Acronym / sponsor ID
- CBNUH_MDCTC_2015_tDCS
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Collaborators
- Samsung Medical Center, Pusan National University Yangsan Hospital
- Study start
- Nov 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Aug 2018 (estimated)
- First posted
- 8 Dec 2016 (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 investigators hypothesize that transcranial direct current stimulation (tDCS) can improve upper limb motor recovery in the sub-acute phase of stroke patients.
This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.
Detailed description
The investigators hypothesize that transcranial direct current stimulation (tDCS) can improve upper limb motor recovery in the sub-acute phase of stroke patients.
This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.
Informed consent was obtained from all participants and procedures were conducted according to the Declaration of Helsinki. The protocol was approved by the Chonbuk National Uni. Hospital IRB, KOREA.
Seventy-two stroke patients in the sub-acute phase will be recruited in three centers of neurorehabilitation in republic of Korea.
Patients will be randomly divided to four groups; group1 is anodal stimulation on the lesioned primary motor cortex, group 2 is cathodal stimulation on the non-lesioned primary motor cortex, group 3 is dual stimulation such as anodal stimulation on the lesioned side and cathod stimulation on the non-lesioned side, and group 4 is shame stimulation group.
The stimulation will be conducted 2mA for 20 minute a day, 5 days per weeks, totally 2 weeks.
Fugl-Meyer upper motor score will be measured as a primary outcome.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| treatment group 1 | Experimental | Device: DC-STIMULATOR PLUSanodal stimulation on the lesioned primary motor cortex DC-STIMULATOR PLUS |
| treatment group 2 | Experimental | Device: DC-STIMULATOR PLUScathodal stimulation on the non-lesioned primary motor cortex DC-STIMULATOR PLUS |
| treatment group 3 | Experimental | Device: DC-STIMULATOR PLUSdual stimulation such as anodal stimulation on the lesioned side and cathodal stimulation on the non-lesioned side DC-STIMULATOR PLUS |
| sham group | Sham comparator | Device: DC-STIMULATOR PLUSsham group |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 20-85
- Unilateral Stroke patients
- Inclusion must be in the sub-acute phase defined as within 48hr-4 weeks after stroke
- Patients who have evoked motor potentials on the first dorsal interossei muscles on hemiplegic hand
- The patient has subscribed the informed consent
Key exclusion criteria (3 listed)
- Insert a metal object on the head
- Convulsive disorders
- History of brain diseases other than stroke
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 |
|---|---|---|
| DC-STIMULATOR PLUSAlso: tDCS2mA for 20minutes a day, 5 days per weeks, totally 2 weeks | Device | sham group, treatment group 1, treatment group 2, treatment group 3 |
Primary outcome
Fugl-Meyer Upper Motor Score change
Time frame: before treatment, 48 hours after treatment, 4 weeks after treatment
3 secondary outcomes
Manual Muscle Test (MMT) change
Time frame: before treatment, 48 hours after treatment, 4 weeks after treatment
Range of Motion (ROM) change
Time frame: before treatment, 48 hours after treatment, 4 weeks after treatment
Korean version Modified Bathel Index (KMBI) change
Time frame: before treatment, 48 hours after treatment, 4 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Individual participant dataSharing planned: Undecided
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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.
Myoung Hwan Ko, MD, PhD principal investigator
634-18, Geumam-dong, Deokjin-gu, Jeonju, Jeonbuk, 561-712 Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DC-STIMULATOR PLUS in people with Stroke, run by Chonbuk National University Hospital 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Dec 2016. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Jung YU, MANAGER (82-63-259-3458 ext. 3458, mjyu@mdctc.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Upper Motor Score change (time frame: before treatment, 48 hours after treatment, 4 weeks after treatment). 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 8 Dec 2016.