Ischemic StrokeDASNCT04938076
Efficacy of Transcranial Direct Current Stimulation in Acute Ischemic Stroke
A study testing Transcranial direct current stimulation in people with Ischemic Stroke, run by Incheon St.Mary's Hospital at 1 site in South Korea.
Trial summary
Non-invasive brain stimulation (tDCS) such as transcranial direct current stimulation (TDCS) has been reported to be effective in improving motor performance and safe in participants with cerebral infarction. However, few studies have been done in participants with acute cerebral infarction. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic 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
- 172 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Apr 2020to 1 Feb 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ischemic stroke patients within 2 days stroke onset
- 18-85 of age
- corticospinal tract involvement stroke (primary motor cortex, corona radiata, internal capsule, midbrain crus cerebri, basis pontis, anterior medulla)
Who cannot join
- pre-stroke disability (defined as modified Rankin Scale (mRS) >=2)
- Intravenous r-tPA thrombolysis or EVT (endovascular thrombectomy)
- history of epilepsy
- advanced systemic disease or coexisting neurological/psychiatric disease
- severe contact dermatitis or skin lesions interfering with the applying the electrode of tDCS
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, 21431
About this study
Official title: Investigation of the Effects of Noninvasive Neuromodulation in Patients With Acute Ischemic Infarction
Non-invasive brain stimulation (tDCS) such as transcranial direct current stimulation (TDCS) has been reported to be effective in improving motor performance and safe in participants with cerebral infarction. However, few studies have been done in participants with acute cerebral infarction. In this study, the investigators want to see the effect of tDCS in acute cerebral infarction. the investigators perform tDCS in participants with acute ischemic stroke within 48 hours after stroke onset and the investigators measure motor weakness and function at early phase as well as at 3 months.
Read the detailed description
Cerebral infarction is a major cause of death, a disease that is socially and nationally burdensome, leaving disabilities and dementia behind.
In participants with cerebral infarction, non-invasive brain stimulation (tDCS) such as transcranial direct current stimulation (TDCS) has been reported to be effective in improving motor performance and safe. However, few studies have been done in participants with acute cerebral infarction, and previous studies in participants with acute cerebral infarction have not verified the effect in mild cerebral infarction, and previous studies in acute cerebral infarction mainly stimulate lesions to anode. So in this study, the investigators want to see the effect of stimulating tDCS to both hemispheres in acute cerebral infarction against this backdrop.
Study Objective: To see if tDCS is effective in improving motor paralysis in participants with acute cerebral infarction.
Expected effectiveness: stability of tDCS has already been demonstrated in many studies. Since tDCS itself is a non-invasive treatment, if the efficacy of the tDCS prove to be effective in patients with acute cerebral infarction, it can be widely implemented without significant risk to many patients.
Intervention : In this randomized controlled trial, the investigators perform tDCS in patients with acute ischemic stroke within 48 hours after stroke onset with sham control.
Outcome : the investigators measure motor weakness and function at early phase as well as at 3 months.
- Conditions
- Ischemic Stroke
- Being tested
- Transcranial direct current stimulation, sham control
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Transcranial direct current stimulation on motor cortex
sham controlDevice
sham control
| Study group | Role | What they receive |
|---|---|---|
| tDCS group | Experimental | tDCS stimulation
* affected side :
1. primary motor cortex (M1 cortex by using the C3 or C4 position of the 10-20 EEG system)
2. 2mA anode (+) for 30 minutes total 10 times for 7 days (ex) twice a day for 5 days)
* contralateral unaffected side
1. primary motor cortex (M1 cortex by using the C3 or C4 position of the 10-20 EEG system)
2. 2mA cathode (-) for 30 minutes total 10 times for 7 days (ex) twice a day for 5 days) Receives: Device: Transcranial direct current stimulation |
| Sham group | Sham comparator | . Sham stimulation
1) the current ramps up to 2mA and slowly decreased over 30 s to ensure the typical initial tingling sensation Receives: Device: sham control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer (FM) motor scale, short form
The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).
Measured: at admission
Fugl-Meyer (FM) motor scale, short form
The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).
Measured: at 7 days
Fugl-Meyer (FM) motor scale, short form
The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).
Measured: at 3 month
NIHSS (National Institutes of Health Stroke Scale)
National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).
Measured: at admission
NIHSS (National Institutes of Health Stroke Scale)
National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).
Measured: at 7 days
NIHSS (National Institutes of Health Stroke Scale)
National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).
Measured: at 3 month
Secondary outcomes (1)
modified Rankin scale
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It has become the most widely used clinical outcome measure for stroke clinical trials.
Measured: at 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start16 Apr 2020
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded randomized control trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incheon St.Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Catholic University of Korea
- Responsible party
- Principal investigator, Taewon Kim, Incheon St.Mary's Hospital
- Investigators
- Taewon Kim, MD, PhD, Principal investigator, Incheon St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938076
- Sponsor's protocol ID
- OC19DESI0124
- Acronym
- DAS
- Status last verified
- Jul 2024
- First submitted
- 15 Jun 2021
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- 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 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Noninvasive Neuromodulation in Patients With Acute Ischemic Infarction
- ClinicalTrials.gov ID
- NCT04938076
- Acronym / sponsor ID
- DAS / OC19DESI0124
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Incheon St.Mary's HospitalUniversity, hospital or other
- Collaborators
- The Catholic University of Korea
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 24 Jun 2021 (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.
Non-invasive brain stimulation (tDCS) such as transcranial direct current stimulation (TDCS) has been reported to be effective in improving motor performance and safe in participants with cerebral infarction. However, few studies have been done in participants with acute cerebral infarction. In this study, the investigators want to see the effect of tDCS in acute cerebral infarction. the investigators perform tDCS in participants with acute ischemic stroke within 48 hours after stroke onset and the investigators measure motor weakness and function at early phase as well as at 3 months.
Detailed description
Cerebral infarction is a major cause of death, a disease that is socially and nationally burdensome, leaving disabilities and dementia behind.
In participants with cerebral infarction, non-invasive brain stimulation (tDCS) such as transcranial direct current stimulation (TDCS) has been reported to be effective in improving motor performance and safe. However, few studies have been done in participants with acute cerebral infarction, and previous studies in participants with acute cerebral infarction have not verified the effect in mild cerebral infarction, and previous studies in acute cerebral infarction mainly stimulate lesions to anode. So in this study, the investigators want to see the effect of stimulating tDCS to both hemispheres in acute cerebral infarction against this backdrop.
Study Objective: To see if tDCS is effective in improving motor paralysis in participants with acute cerebral infarction.
Expected effectiveness: stability of tDCS has already been demonstrated in many studies. Since tDCS itself is a non-invasive treatment, if the efficacy of the tDCS prove to be effective in patients with acute cerebral infarction, it can be widely implemented without significant risk to many patients.
Intervention : In this randomized controlled trial, the investigators perform tDCS in patients with acute ischemic stroke within 48 hours after stroke onset with sham control.
Outcome : the investigators measure motor weakness and function at early phase as well as at 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded randomized control trial
| Arm | Type | Receives |
|---|---|---|
| tDCS group | Experimental | Device: Transcranial direct current stimulationtDCS stimulation * affected side : 1. primary motor cortex (M1 cortex by using the C3 or C4 position of the 10-20 EEG system) 2. 2mA anode (+) for 30 minutes total 10 times for 7 days (ex) twice a day for 5 days) * contralateral unaffected side 1. primary motor cortex (M1 cortex by using the C3 or C4 position of the 10-20 EEG system) 2. 2mA cathode (-) for 30 minutes total 10 times for 7 days (ex) twice a day for 5 days) |
| Sham group | Sham comparator | Device: sham control. Sham stimulation 1) the current ramps up to 2mA and slowly decreased over 30 s to ensure the typical initial tingling sensation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ischemic stroke patients within 2 days stroke onset
- 18-85 of age
- corticospinal tract involvement stroke (primary motor cortex, corona radiata, internal capsule, midbrain crus cerebri, basis pontis, anterior medulla)
Key exclusion criteria (5 listed)
- pre-stroke disability (defined as modified Rankin Scale (mRS) >=2)
- Intravenous r-tPA thrombolysis or EVT (endovascular thrombectomy)
- history of epilepsy
- advanced systemic disease or coexisting neurological/psychiatric disease
- severe contact dermatitis or skin lesions interfering with the applying the electrode of tDCS
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 stimulationTranscranial direct current stimulation on motor cortex | Device | tDCS group |
| sham controlsham control | Device | Sham group |
Primary outcome
Fugl-Meyer (FM) motor scale, short form
Time frame: at admission
The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).
Fugl-Meyer (FM) motor scale, short form
Time frame: at 7 days
The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).
Fugl-Meyer (FM) motor scale, short form
Time frame: at 3 month
The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).
NIHSS (National Institutes of Health Stroke Scale)
Time frame: at admission
National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).
NIHSS (National Institutes of Health Stroke Scale)
Time frame: at 7 days
National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).
NIHSS (National Institutes of Health Stroke Scale)
Time frame: at 3 month
National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).
1 secondary outcome
modified Rankin scale
Time frame: at 3 month
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 24 Jul 2024.
- 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.
Taewon Kim, MD, PhD principal investigator
Incheon St.Mary's Hospital
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 Ischemic Stroke, run by Incheon St.Mary's 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 3 inclusion and 5 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 24 Jul 2024. 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?
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 (FM) motor scale, short form (time frame: at admission). The study lists 6 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 24 Jul 2024.