StrokeNCT03486782
Dual Site-dual Channel Non-invasive Brain Stimulation for Language and Cognitive Function in Stroke Patients
A study testing IFG stimulation, DLPFC stimulation and aphasia therapy in people with Stroke and Aphasia, 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 language and cognitive 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 years and older
- Conditions the study is for
- Stroke, Aphasia, Cognitive Impairment
- What is being tested?
- IFG stimulation, DLPFC stimulation and aphasia therapy
- 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
- 29 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- left hemisphere involved stroke patients
- patients diagnoses as post stroke aphasia
Who cannot join
- history of psychiatric disease
- patients with metal implants
- history of epilepsy
- pregnancy
- skin defect at the site of electrode attachment
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 Language and Cognitive 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 language and cognitive 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 four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) Dual stimulation: i) anodal stimulation on ipsilesional inferior frontal cortex, ii) anodal stimulation on ipsilesional dorsolateral prefrontal cortex. 2) Single stimulation 1: anodal stimulation on ipsilesional inferior frontal cortex and cathodal stimulation on contralesional inferior frontal cortex; 3) Single stimulation 2: anodal stimulation on ipsilesional inferior frontal cortex and cathodal stimulation on contralesional supraorbital area.
- Conditions
- Stroke, Aphasia, Cognitive Impairment
- Being tested
- IFG stimulation, DLPFC stimulation, aphasia therapy
- Keywords
- transcranial direct current stimulation, dual stimulation
- Medical subject headings
- Stroke, Aphasia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IFG stimulationDevice
stimulating inferior frontal cortex with transcranial direct current stimulation for 30 minutes
DLPFC stimulationDevice
stimulating dorsolateral prefrontal cortex with transcranial direct current stimulation for 30 minutes
aphasia therapyBehavioural
aphasia therapy for 30 minutes during transcranial direct current stimulation
| Study group | Role | What they receive |
|---|---|---|
| Dual stimulation | Active comparator | i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional supraorbital area ii) anodal stimulation on ipsilesional dorsolateral prefrontal cortex and cathodal stimulation of contralesional supraorbital area Receives: Device: IFG stimulation; Device: DLPFC stimulation; Behavioral: aphasia therapy |
| Single stimulation 1 | Active comparator | i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional inferior frontal cortex Receives: Device: IFG stimulation; Behavioral: aphasia therapy |
| Single stimulation 2 | Active comparator | i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional supraorbital area Receives: Device: IFG stimulation; Behavioral: aphasia therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Korean Boston naming test
measures naming ability thorough picture naming test
Measured: Baseline and after intervention (approximately 2 weeks)
Changes in Korean Western Aphasia Battery
assessment of language function and provide aphasia quotients
Measured: Baseline and after intervention (approximately 2 weeks)
Secondary outcomes (6)
Digit span test
measures memory span
Measured: Baseline and after intervention (approximately 2 weeks)
Korea Montreal Cognitive Assessment
measure cognitive function
Measured: Baseline and after intervention (approximately 2 weeks)
Korean Color Word Stroop test
measures selective attention and executive function
Measured: Baseline and after intervention (approximately 2 weeks)
Controlled Oral Word Association Test
measure verbal fluency
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)
Changes in brain activation of resting-state and task functional MRI
Neuroplasticity measure
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 start29 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
- NCT03486782
- Sponsor's protocol ID
- 2017-08-124-B
- 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 Language and Cognitive Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT03486782
- Acronym / sponsor ID
- 2017-08-124-B
- Conditions
- Stroke, Aphasia, Cognitive Impairment
- 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
- 29 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 language and cognitive 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 four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) Dual stimulation: i) anodal stimulation on ipsilesional inferior frontal cortex, ii) anodal stimulation on ipsilesional dorsolateral prefrontal cortex. 2) Single stimulation 1: anodal stimulation on ipsilesional inferior frontal cortex and cathodal stimulation on contralesional inferior frontal cortex; 3) Single stimulation 2: anodal stimulation on ipsilesional inferior frontal cortex and cathodal stimulation on contralesional supraorbital area.
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 | Active comparator | Device: IFG stimulation, Device: DLPFC stimulation, Behavioral: aphasia therapyi) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional supraorbital area ii) anodal stimulation on ipsilesional dorsolateral prefrontal cortex and cathodal stimulation of contralesional supraorbital area |
| Single stimulation 1 | Active comparator | Device: IFG stimulation, Behavioral: aphasia therapyi) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional inferior frontal cortex |
| Single stimulation 2 | Active comparator | Device: IFG stimulation, Behavioral: aphasia therapyi) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional supraorbital area |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- left hemisphere involved stroke patients
- patients diagnoses as post stroke aphasia
Key exclusion criteria (5 listed)
- history of psychiatric disease
- patients with metal implants
- history of epilepsy
- pregnancy
- skin defect at the site of electrode attachment
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 |
|---|---|---|
| IFG stimulationstimulating inferior frontal cortex with transcranial direct current stimulation for 30 minutes | Device | Dual stimulation, Single stimulation 1, Single stimulation 2 |
| DLPFC stimulationstimulating dorsolateral prefrontal cortex with transcranial direct current stimulation for 30 minutes | Device | Dual stimulation |
| aphasia therapyaphasia therapy for 30 minutes during transcranial direct current stimulation | Behavioural | Dual stimulation, Single stimulation 1, Single stimulation 2 |
Primary outcome
Changes in Korean Boston naming test
Time frame: Baseline and after intervention (approximately 2 weeks)
measures naming ability thorough picture naming test
Changes in Korean Western Aphasia Battery
Time frame: Baseline and after intervention (approximately 2 weeks)
assessment of language function and provide aphasia quotients
6 secondary outcomes
Digit span test
Time frame: Baseline and after intervention (approximately 2 weeks)
Korea Montreal Cognitive Assessment
Time frame: Baseline and after intervention (approximately 2 weeks)
Korean Color Word Stroop test
Time frame: Baseline and after intervention (approximately 2 weeks)
Controlled Oral Word Association Test
Time frame: Baseline and after intervention (approximately 2 weeks)
Changes of Cortical activation
Time frame: Baseline and after intervention (approximately 2 weeks)
Changes in brain activation of resting-state and task functional MRI
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
Related trials for Stroke
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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
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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 IFG stimulation, DLPFC stimulation and aphasia therapy in people with Stroke and Aphasia, 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 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 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 Korean Boston naming test (time frame: Baseline and after intervention (approximately 2 weeks)). The study lists 2 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 27 May 2020.