StrokeNCT05275114
Improvement Effect of Transcranial Direct Current Stimulation (tDCS) Applied During Exercise Training in Stroke Patients With Upper Limb and Hand Motor Function
A study testing tDCS stimulation with hand task in people with Stroke, run by Yun-Hee Kim at 1 site in South Korea.
Trial summary
The purpose of this study was to improve the effect of Transcranial Direct Current Stimulation (tDCS) applied during exercise training in stroke patients with upper limb and hand motor function. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- tDCS stimulation with hand task
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Mar 2022to 31 Aug 2022
- 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
- Patients aged 19 to 80 years
- Less than 58 FMA Upper scores
- Patients whose lesions do not include stimulation regions
- Patients with stroke with more than 3 months of onset
Who cannot join
- Difficult to communicate due to severe language impairment.
- Accompanied by an existing serious neurogenic disease
- Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder
- If there are difficulties in conducting the research
- Any patients who are judged by the investigator to be difficult to participate in this study
- Patients with contraindicated MRI scans
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to improve the effect of Transcranial Direct Current Stimulation (tDCS) applied during exercise training in stroke patients with upper limb and hand motor function.
- Conditions
- Stroke
- Being tested
- tDCS stimulation with hand task, sham tDCS stimulation with hand task
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS stimulation with hand taskDevice
30 minutes of intervention including tDCS stimulation with hand task and fNIRS measurements for 10 days in 4 weeks
sham tDCS stimulation with hand taskDevice
30 minutes of intervention including sham tDCS stimulation with hand task and fNIRS measurements for 10 days in 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Hand Tasks + M1(1mA) & aIPS(1mA) tDCS | Experimental | 20 minutes of Hand Taks + applying 30 minutes of M1(1mA) \& aIPS(1mA) tDCS and fNIRS Receives: Device: tDCS stimulation with hand task |
| Hand Tasks + Sham tDCS | Active comparator | 20 minutes of Hand Tasks + 30 minutes of sham tDCS and fNIRS Receives: Device: sham tDCS stimulation with hand task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 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: Session 0 (initial visit);; Session 10 (at approximatel 4 weeks)
Secondary outcomes (7)
Change in 9-hole pegboard test
The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.
Measured: Baseline(initial visit); Session 10 (at approximatel 4 weeks)
Change in Grip & Tip pinch strength
The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.
Measured: Baseline(initial visit); Session 10 (at approximatel 4 weeks)
Change in Sequential finger tapping reaction time and accruacy
Response time and accuracy are measured during finger tapping task.
Measured: Baseline(initial visit); Session 10 (at approximatel 4 weeks)
Change in Jebsen-Taylor hand function test
This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL).
Measured: Baseline(initial visit); Session 10 (at approximatel 4 weeks)
Change in Box and 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(initial visit); Session 10 (at approximatel 4 weeks)
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: [Time Frame: session 0 (initial visit); session 10 (at approximately 4 weeks)]
Changes in Brain activation of resting-state functional MRI
Measure of Neuroplasticity
Measured: [Time Frame: session 0 (initial visit); session 10 (at approximately 4 weeks)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start11 Mar 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
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.
- 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
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yun-Hee Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Cybermedic Co., Ltd.
- Responsible party
- Sponsor-investigator, Yun-Hee Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275114
- Sponsor's protocol ID
- 2021-06-176
- Status last verified
- Sep 2022
- First submitted
- 1 Mar 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee SH, Lee G, Kim J, Phillips V Z, Kim H, Kim E, Lee SH, Jeong HC, Paik SH, Kim YH, Kim BM. Resting-state hemodynamic changes and effects on upper limb function after multi-channel transcranial direct current stimulation to the ipsilesional primary motor cortex and anterior intraparietal sulcus in stroke patients: an fNIRS pilot study. J Neuroeng Rehabil. 2025 Apr 16;22(1):83. doi: 10.1186/s12984-025-01618-8.
PubMed 40241110
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement Effect of Transcranial Direct Current Stimulation (tDCS) Applied During Exercise Training in Stroke Patients With Upper Limb and Hand Motor Function
- ClinicalTrials.gov ID
- NCT05275114
- Acronym / sponsor ID
- 2021-06-176
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Yun-Hee KimUniversity, hospital or other
- Collaborators
- Cybermedic Co., Ltd.
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 11 Mar 2022 (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 was to improve the effect of Transcranial Direct Current Stimulation (tDCS) applied during exercise training in stroke patients with upper limb and hand motor function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand Tasks + M1(1mA) & aIPS(1mA) tDCS | Experimental | Device: tDCS stimulation with hand task20 minutes of Hand Taks + applying 30 minutes of M1(1mA) \& aIPS(1mA) tDCS and fNIRS |
| Hand Tasks + Sham tDCS | Active comparator | Device: sham tDCS stimulation with hand task20 minutes of Hand Tasks + 30 minutes of sham tDCS and fNIRS |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 19 to 80 years
- Less than 58 FMA Upper scores
- Patients whose lesions do not include stimulation regions
- Patients with stroke with more than 3 months of onset
Key exclusion criteria (6 listed)
- Difficult to communicate due to severe language impairment.
- Accompanied by an existing serious neurogenic disease
- Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder
- If there are difficulties in conducting the research
- Any patients who are judged by the investigator to be difficult to participate in this study
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 |
|---|---|---|
| tDCS stimulation with hand task30 minutes of intervention including tDCS stimulation with hand task and fNIRS measurements for 10 days in 4 weeks | Device | Hand Tasks + M1(1mA) & aIPS(1mA) tDCS |
| sham tDCS stimulation with hand task30 minutes of intervention including sham tDCS stimulation with hand task and fNIRS measurements for 10 days in 4 weeks | Device | Hand Tasks + Sham tDCS |
Primary outcome
Change in Fugl-Meyer Assessment
Time frame: Session 0 (initial visit);; Session 10 (at approximatel 4 weeks)
The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured.
7 secondary outcomes
Change in 9-hole pegboard test
Time frame: Baseline(initial visit); Session 10 (at approximatel 4 weeks)
Change in Grip & Tip pinch strength
Time frame: Baseline(initial visit); Session 10 (at approximatel 4 weeks)
Change in Sequential finger tapping reaction time and accruacy
Time frame: Baseline(initial visit); Session 10 (at approximatel 4 weeks)
Change in Jebsen-Taylor hand function test
Time frame: Baseline(initial visit); Session 10 (at approximatel 4 weeks)
Change in Box and Block test
Time frame: Baseline(initial visit); Session 10 (at approximatel 4 weeks)
Changes in motor evoked potential
Time frame: [Time Frame: session 0 (initial visit); session 10 (at approximately 4 weeks)]
Changes in Brain activation of resting-state functional MRI
Time frame: [Time Frame: session 0 (initial visit); session 10 (at approximately 4 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 21 Sep 2022.
- Derived from this study: PubMed 40241110Lee SH, Lee G, Kim J, Phillips V Z, Kim H, Kim E, Lee SH, Jeong HC, Paik SH, Kim YH, Kim BM. Resting-state hemodynamic changes and effects on upper limb function after multi-channel transcranial direct current stimulation to the ipsilesional primary motor cortex and anterior intraparietal sulcus in stroke patients: an fNIRS pilot study. J Neuroeng Rehabil. 2025 Apr 16;22(1):83. doi: 10.1186/s12984-025-01618-8.
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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 tDCS stimulation with hand task in people with Stroke, run by Yun-Hee Kim 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 6 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 21 Sep 2022. 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?
Change in Fugl-Meyer Assessment (time frame: Session 0 (initial visit);; Session 10 (at approximatel 4 weeks)). 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 NCT05275114, 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 21 Sep 2022.