Acupuncture-tDCS Convergence Rehabilitation Effect on Stroke Patients

Stroke, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05648162
• Other study ID #: 03-2022-002
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Pusan National University Yangsan Hospital
• Contact: JISOO BAIK
• Phone: +82553604159
• Email: zisoo[@]pusan.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Device:
• Electrical acupuncture
Electrical acupuncture (2Hz, 150 µs) once daily
• Acupuncture
Electrical acupuncture (no electricity) once daily
• tDCS
tDCS (1mA) once daily
• sham tDCS
tDCS (no electricity) once daily

Locations

Country	Name	City	State
Korea, Republic of	Pusan national university Yangsan Hospital	Gyeongsang	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and Week 4
Primary	Change of brain activity	The fNIRS(functional Near-Infrared Spectroscopy) is a imaged, instrument assessing average brain activity. Change= (Week 4 Score - Baseline Score).	Baseline and Week 4
Secondary	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).	Baseline and Week 4