StrokeNCT03390192
Noninvasive Dual-mode Stimulation Therapy for Neurorehabilitation in Stroke
A study testing Dual-mode stimulation in people with Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of stroke patients' motor function by altering the cortical excitability. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Dual-mode stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jan 2015to 13 Mar 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-ever stroke patients
- Subacute stage (less than 4 weeks)
- Total Fugl-Meyer Assessment (FMA) score under 84
Who cannot join
- Major active neurological disease or psychiatric disease
- A history of seizure
- Metallic implants in their brain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation for Individualized Noninvasive Neuromodulation in Neurorehabilitation of Brain Disease: Longitudinal Study
Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of stroke patients' motor function by altering the cortical excitability. Recently, more challenging approaches, such as stimulation of two or more sites or use of dual modality have been studied in stroke patients. In this study, simultaneous stimulation using both inhibitory rTMS (1Hz) and anodal tDCS (dual-mode stimulation) over bilateral primary motor cortices (M1s) was investigated to compare its modulatory effects with single inhibitory rTMS stimulation in subacute stroke patients.
- Conditions
- Stroke
- Being tested
- Dual-mode stimulation, Single sham stimulation
- Keywords
- Noninvasive brain stimulation, Repetitive Transcranial Magnetic Stimulation, 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.
Dual-mode stimulationDevice
1Hz rTMS over contralesional primary motor cortex and anodal tDCS over ipsilesional primary motor cortex are simultaneously simulated.
Single sham stimulationDevice
1Hz rTMS over contralesional primary motor cortex and sham tDCS (no stimulation) over ipsilesional primary motor cortex are simultaneously simulated.
| Study group | Role | What they receive |
|---|---|---|
| Dual-mode stimulation | Experimental | Dual-mode stimulation is applied over the bilateral primary motor cortex (M1) using active rTMS and active tDCS. 1 Hz of rTMS is applied over the contralesional M1 for 20 minutes with simultaneous application of anodal tDCS on the ipsilesional M1.
Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired. Receives: Device: Dual-mode stimulation |
| Single sham stimulation | Active comparator | Single sham stimulation is applied over the bilateral primary motor cortex (M1) using active rTMS and sham tDCS. 1 Hz of rTMS over the contralesional M1 was applied for 20 minutes with simultaneous application of tDCS with sham mode (no stimulation) on the ipsilesional M1.
Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired. Receives: Device: Single sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment score
Fugl-Meyer Assessment score reflects a motor impairment of a patient. Score range is between 0 and 100.
Measured: 2 months post-stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start13 Jan 2015
- Primary completion13 Mar 2018
- Study completion13 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 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
- NCT03390192
- Sponsor's protocol ID
- 2013-06-002-009
- Status last verified
- Dec 2017
- First submitted
- 25 Dec 2017
- Last updated
- 19 Sep 2019
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee J, Lee A, Kim H, Shin M, Yun SM, Jung Y, Chang WH, Kim YH. Different Brain Connectivity between Responders and Nonresponders to Dual-Mode Noninvasive Brain Stimulation over Bilateral Primary Motor Cortices in Stroke Patients. Neural Plast. 2019 Apr 7;2019:3826495. doi: 10.1155/2019/3826495. eCollection 2019.
PubMed 31093270
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation for Individualized Noninvasive Neuromodulation in Neurorehabilitation of Brain Disease: Longitudinal Study
- ClinicalTrials.gov ID
- NCT03390192
- Acronym / sponsor ID
- 2013-06-002-009
- Conditions
- Stroke
- Keywords
- Noninvasive brain stimulation, Repetitive Transcranial Magnetic Stimulation, Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 13 Jan 2015 (actual)
- Primary completion
- 13 Mar 2018 (actual)
- Study completion
- 13 Mar 2018 (actual)
- First posted
- 4 Jan 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.
Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of stroke patients' motor function by altering the cortical excitability. Recently, more challenging approaches, such as stimulation of two or more sites or use of dual modality have been studied in stroke patients. In this study, simultaneous stimulation using both inhibitory rTMS (1Hz) and anodal tDCS (dual-mode stimulation) over bilateral primary motor cortices (M1s) was investigated to compare its modulatory effects with single inhibitory rTMS stimulation in subacute stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual-mode stimulation | Experimental | Device: Dual-mode stimulationDual-mode stimulation is applied over the bilateral primary motor cortex (M1) using active rTMS and active tDCS. 1 Hz of rTMS is applied over the contralesional M1 for 20 minutes with simultaneous application of anodal tDCS on the ipsilesional M1. Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired. |
| Single sham stimulation | Active comparator | Device: Single sham stimulationSingle sham stimulation is applied over the bilateral primary motor cortex (M1) using active rTMS and sham tDCS. 1 Hz of rTMS over the contralesional M1 was applied for 20 minutes with simultaneous application of tDCS with sham mode (no stimulation) on the ipsilesional M1. Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First-ever stroke patients
- Subacute stage (less than 4 weeks)
- Total Fugl-Meyer Assessment (FMA) score under 84
Key exclusion criteria (3 listed)
- Major active neurological disease or psychiatric disease
- A history of seizure
- Metallic implants in their brain
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 |
|---|---|---|
| Dual-mode stimulation1Hz rTMS over contralesional primary motor cortex and anodal tDCS over ipsilesional primary motor cortex are simultaneously simulated. | Device | Dual-mode stimulation |
| Single sham stimulation1Hz rTMS over contralesional primary motor cortex and sham tDCS (no stimulation) over ipsilesional primary motor cortex are simultaneously simulated. | Device | Single sham stimulation |
Primary outcome
Fugl-Meyer Assessment score
Time frame: 2 months post-stimulation
Fugl-Meyer Assessment score reflects a motor impairment of a patient. Score range is between 0 and 100.
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 19 Sep 2019.
- Derived from this study: PubMed 31093270Lee J, Lee A, Kim H, Shin M, Yun SM, Jung Y, Chang WH, Kim YH. Different Brain Connectivity between Responders and Nonresponders to Dual-Mode Noninvasive Brain Stimulation over Bilateral Primary Motor Cortices in Stroke Patients. Neural Plast. 2019 Apr 7;2019:3826495. doi: 10.1155/2019/3826495. eCollection 2019.
- 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 Dual-mode 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 3 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: finished, as of the sponsor's last update on 19 Sep 2019. 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?
Fugl-Meyer Assessment score (time frame: 2 months post-stimulation). 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 NCT03390192, which also lists 1 linked publication.
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 19 Sep 2019.