StrokeNCT04549753
A Study on Brain Activity During Transcranial Direct Current Stimulation in Stroke Patients
A study testing Transcranial direct current simulation in people with Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to identify the characteristics of neural plasticity seen in stroke patients by measuring the changes in brain activity during stimulation using functional near-infrared spectroscopy (fNIRS) when applying transcranial direct current stimulation (tDCS) for the purpose of enhancing finger… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Transcranial direct current simulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Sep 2020to 10 Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral stroke patients
- Chronic patients over 6 months after onset
- Subcortical stroke
- Patients with the movement of fingers
Who cannot join
- History of psychiatric disease
- Significant other neurological diseases except for stroke
- Difficult to perform this experiment
- 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: A Study on Brain Activity During Transcranial Direct Current Stimulation for Improving Finger-Hand Function in Stroke Patients
The purpose of this study is to identify the characteristics of neural plasticity seen in stroke patients by measuring the changes in brain activity during stimulation using functional near-infrared spectroscopy (fNIRS) when applying transcranial direct current stimulation (tDCS) for the purpose of enhancing finger function.
- Conditions
- Stroke
- Being tested
- Transcranial direct current simulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current simulationDevice
Four sessions of stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system
| Study group | Role | What they receive |
|---|---|---|
| tDCS stimulation group | Experimental | Patients receive four sessions of tDCS stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system. Receives: Device: Transcranial direct current simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cortical activity using fNIRS signals during brain stimulation
Cortical activities before and after brain stimulation sessions are compared.
Measured: Baseline and about 10 days (immediately after brain stimulation sessions)
Secondary outcomes (6)
Changes in motor evoked potential
Resting motor threshold (rMT) and amplitude of motor evoked potential in first dorsal interosseous muscle are measured. These outcomes are measured by transcranial magnetic stimulation over the motor hotspot. The rMT is defined as the minimum stimulus intensity that produced a minimal motor evoked response at rest. The amplitude means peak to peak of the muscle response.
Measured: Baseline and about 10 days (immediately after brain stimulation sessions)
9-hole pegboard test
The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.
Measured: Baseline and about 10 days (immediately after brain stimulation sessions)
Grip & Tip pinch strength test
The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.
Measured: Baseline and about 10 days (immediately after brain stimulation sessions)
Box & Block test
The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device.
Measured: Baseline and about 10 days (immediately after brain stimulation sessions)
Fugl-Meyer Assessment
The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured.
Measured: Baseline and about 10 days (immediately after brain stimulation sessions)
Finger tapping test
Response time is measured during finger tapping task.
Measured: Baseline and about 10 days (immediately after brain stimulation sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start15 Sep 2020
- Primary completion10 Dec 2020
- Study completion10 Dec 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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
- NCT04549753
- Sponsor's protocol ID
- 2020-04-183
- Status last verified
- Sep 2020
- First submitted
- 2 Sep 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Brain Activity During Transcranial Direct Current Stimulation for Improving Finger-Hand Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT04549753
- Acronym / sponsor ID
- 2020-04-183
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 16 Sep 2020 (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 purpose of this study is to identify the characteristics of neural plasticity seen in stroke patients by measuring the changes in brain activity during stimulation using functional near-infrared spectroscopy (fNIRS) when applying transcranial direct current stimulation (tDCS) for the purpose of enhancing finger function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tDCS stimulation group | Experimental | Device: Transcranial direct current simulationPatients receive four sessions of tDCS stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral stroke patients
- Chronic patients over 6 months after onset
- Subcortical stroke
- Patients with the movement of fingers
Key exclusion criteria (7 listed)
- History of psychiatric disease
- Significant other neurological diseases except for stroke
- Difficult to perform this experiment
- Patients with metal implants
- History of epilepsy
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 simulationFour sessions of stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system | Device | tDCS stimulation group |
Primary outcome
Changes in cortical activity using fNIRS signals during brain stimulation
Time frame: Baseline and about 10 days (immediately after brain stimulation sessions)
Cortical activities before and after brain stimulation sessions are compared.
6 secondary outcomes
Changes in motor evoked potential
Time frame: Baseline and about 10 days (immediately after brain stimulation sessions)
9-hole pegboard test
Time frame: Baseline and about 10 days (immediately after brain stimulation sessions)
Grip & Tip pinch strength test
Time frame: Baseline and about 10 days (immediately after brain stimulation sessions)
Box & Block test
Time frame: Baseline and about 10 days (immediately after brain stimulation sessions)
Fugl-Meyer Assessment
Time frame: Baseline and about 10 days (immediately after brain stimulation sessions)
Finger tapping test
Time frame: Baseline and about 10 days (immediately after brain stimulation sessions)
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 10 Mar 2021.
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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 Transcranial direct current simulation 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 4 inclusion and 7 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 10 Mar 2021. 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 cortical activity using fNIRS signals during brain stimulation (time frame: Baseline and about 10 days (immediately after brain stimulation sessions)). 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 10 Mar 2021.