Stroke, AcuteNCT05648162

Acupuncture-tDCS Convergence Rehabilitation Effect on Stroke Patients

A study testing Electrical acupuncture, Acupuncture and tDCS in people with Stroke, Acute, run by Pusan National University Yangsan Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to confirm the convergence effectiveness of on acupuncture of the chinese medicine and the tDCS of the western medicine on motor function for patients with acute stroke compared to the control group. Read more about this study

Who is it for?: Ages 20 to 100 years
Conditions the study is for: Stroke, Acute
What is being tested?: Electrical acupuncture, Acupuncture and tDCS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 1 siteSouth Korea
Study dates: 5 Jul 2022to 31 Dec 2023
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 20 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Those who within 2 weeks or more and 6 months after a stroke diagnosis.
Those who have a lesion with a cortex or subcortex
Adults over 19 years old
Inpatients and outpatients who can mediate for 4 weeks
Those who can understand and follow the purpose of this study

Who cannot join

Those who fall under the exclusion criteria for electrical acupuncture or acupuncture or tDCS
Those who have a experience about adverse reaction to the existing electrical acupuncture or acupuncture or tDCS
Those who have major psychiatric diseases such as major depression disorders, schizophrenia, bipolar disorders, and dementia
A person who judges that it is not appropriate for a researcher to participate in this study

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Pusan national university Yangsan Hospital
Gyeongsang, Yangsan, 50610

Other trials in South Korea

About this study

Official title: Convergence of Acupuncture and Transcranial Direct Current Stimulation(tDCS) Rehabilitation Effect on Motor Function of Patients of Acute Stroke

Conditions: Stroke, Acute
Being tested: Electrical acupuncture, Acupuncture, tDCS, sham tDCS, NDT-Bobath Rehabilitation
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Electrical acupunctureDevice
Electrical acupuncture (2Hz, 150 μs) once daily (five times a week), for 20 minutes each session, totaling 20 sessions.
AcupunctureDevice
Electrical acupuncture (no electricity) once daily (five times a week), for 20 minutes each session, totaling 20 sessions.
tDCSDevice
tDCS (1mA) once daily (five times a week), for 20 minutes each session, totaling 20 sessions.
sham tDCSDevice
tDCS (no electricity) once daily (five times a week), for 20 minutes each session, totaling 20 sessions.
NDT-Bobath RehabilitationOther
NDT-Bobath Rehabilitation once daily (five times a week), for 30 minutes each session, totaling 20 sessions.

Study groups in NCT05648162
Study group	Role	What they receive
Electrical acupuncture+ tDCS + NDT-Bobath Rehabilitation	Experimental	Electrical acupuncture, tDCS, and NDT-BOBATH rehabilitation were performed for 30 minutes per time, respectively. The number of intervention was held for about a month, five times a week(a total of 20 times). Receives: Device: Electrical acupuncture; Device: tDCS; Other: NDT-Bobath Rehabilitation
Acupuncture + sham tDCS + NDT-Bobath Rehabilitation	Active comparator	Acupuncture, tDCS, and NDT-BOBATH rehabilitation were performed for 30 minutes per time, respectively. The number of intervention was held for about a month, five times a week(a total of 20 times). Receives: Device: Acupuncture; Device: sham tDCS; Other: NDT-Bobath Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of Korean version of the Fugl-Meyer Assessment Scale(K-FMA) score
The FMA is a validated, instrument assessing average motor function of upper and lower extremity. Possible scores range from 0(worst motor function) to 212(best motor function). Change= (Week 4 Score - Baseline Score).
Measured: Baseline and Week 4
Change of brain activity
The fNIRS(functional Near-Infrared Spectroscopy) is a imaged, instrument assessing average brain activity. Change= (Week 4 Score - Baseline Score).
Measured: Baseline and Week 4

Secondary outcomes (1)

Change of Korean version of Modified Barthel Index(K-MBI) score
The MBI is a validated, instrument assessing average level of ADL(activity of daily living). Possible scores range from 0(maximal independence) to 100(minimal independence). Change= (Week 4 Score - Baseline Score).
Measured: Baseline and Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jul 202231 Dec 2023

First posted13 Dec 2022
Study start5 Jul 2022
Primary completion31 Dec 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stroke, AcuteStudies 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: Participant, Outcomes assessor
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05648162
Sponsor's protocol ID: 03-2022-002
Status last verified: May 2024
First submitted: 5 Dec 2022
Last updated: 20 May 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke, Acute trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Convergence of Acupuncture and Transcranial Direct Current Stimulation(tDCS) Rehabilitation Effect on Motor Function of Patients of Acute Stroke
ClinicalTrials.gov ID: NCT05648162
Acronym / sponsor ID: 03-2022-002
Conditions: Stroke, Acute
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Pusan National University Yangsan HospitalUniversity, hospital or other
Study start: 5 Jul 2022 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 13 Dec 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Electrical acupuncture+ tDCS + NDT-Bobath Rehabilitation	Experimental	Device: Electrical acupuncture, Device: tDCS, Other: NDT-Bobath RehabilitationElectrical acupuncture, tDCS, and NDT-BOBATH rehabilitation were performed for 30 minutes per time, respectively. The number of intervention was held for about a month, five times a week(a total of 20 times).
Acupuncture + sham tDCS + NDT-Bobath Rehabilitation	Active comparator	Device: Acupuncture, Device: sham tDCS, Other: NDT-Bobath RehabilitationAcupuncture, tDCS, and NDT-BOBATH rehabilitation were performed for 30 minutes per time, respectively. The number of intervention was held for about a month, five times a week(a total of 20 times).

Who may qualify

Ages: 20 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Those who within 2 weeks or more and 6 months after a stroke diagnosis.
Those who have a lesion with a cortex or subcortex
Adults over 19 years old
Inpatients and outpatients who can mediate for 4 weeks
Those who can understand and follow the purpose of this study

Key exclusion criteria (4 listed)

Those who fall under the exclusion criteria for electrical acupuncture or acupuncture or tDCS
Those who have a experience about adverse reaction to the existing electrical acupuncture or acupuncture or tDCS
Those who have major psychiatric diseases such as major depression disorders, schizophrenia, bipolar disorders, and dementia
A person who judges that it is not appropriate for a researcher 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
Electrical acupunctureElectrical acupuncture (2Hz, 150 μs) once daily (five times a week), for 20 minutes each session, totaling 20 sessions.	Device	Electrical acupuncture+ tDCS + NDT-Bobath Rehabilitation
AcupunctureElectrical acupuncture (no electricity) once daily (five times a week), for 20 minutes each session, totaling 20 sessions.	Device	Acupuncture + sham tDCS + NDT-Bobath Rehabilitation
tDCStDCS (1mA) once daily (five times a week), for 20 minutes each session, totaling 20 sessions.	Device	Electrical acupuncture+ tDCS + NDT-Bobath Rehabilitation
sham tDCStDCS (no electricity) once daily (five times a week), for 20 minutes each session, totaling 20 sessions.	Device	Acupuncture + sham tDCS + NDT-Bobath Rehabilitation
NDT-Bobath RehabilitationNDT-Bobath Rehabilitation once daily (five times a week), for 30 minutes each session, totaling 20 sessions.	Other	Acupuncture + sham tDCS + NDT-Bobath Rehabilitation, Electrical acupuncture+ tDCS + NDT-Bobath Rehabilitation

Primary outcome

Change of Korean version of the Fugl-Meyer Assessment Scale(K-FMA) score
Time frame: Baseline and Week 4
The FMA is a validated, instrument assessing average motor function of upper and lower extremity. Possible scores range from 0(worst motor function) to 212(best motor function). Change= (Week 4 Score - Baseline Score).
Change of brain activity
Time frame: Baseline and Week 4
The fNIRS(functional Near-Infrared Spectroscopy) is a imaged, instrument assessing average brain activity. Change= (Week 4 Score - Baseline Score).

1 secondary outcome

Change of Korean version of Modified Barthel Index(K-MBI) score
Time frame: Baseline and Week 4

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 20 May 2024.
Individual participant dataSharing planned: No

Related trials for Stroke, Acute

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke

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.

Young-Il Shin, Dr. study director

Pusan National University Yangsan 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 Electrical acupuncture, Acupuncture and tDCS in people with Stroke, Acute, run by Pusan National University Yangsan 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 5 inclusion and 4 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 20 May 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. 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 of Korean version of the Fugl-Meyer Assessment Scale(K-FMA) score (time frame: Baseline and Week 4). 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?

On the ClinicalTrials.gov record for NCT05648162.

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 20 May 2024.