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Completed

NCT Number: NCT05648162

Acupuncture-tDCS Convergence Rehabilitation Effect on Stroke Patients

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.

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan national university Yangsan Hospital

Gyeongsang, Yangsan, 50610, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrical acupuncture

Device

Electrical acupuncture (2Hz, 150 μs) once daily (five times a week), for 20 minutes each session, totaling 20 sessions.

acupuncture

Device

Electrical acupuncture (no electricity) once daily (five times a week), for 20 minutes each session, totaling 20 sessions.

tDCS

Device

tDCS (1mA) once daily (five times a week), for 20 minutes each session, totaling 20 sessions.

Sham tDCS

Device

tDCS (no electricity) once daily (five times a week), for 20 minutes each session, totaling 20 sessions.

NDT-Bobath Rehabilitation

Other

NDT-Bobath Rehabilitation once daily (five times a week), for 30 minutes each session, totaling 20 sessions.

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. Change of Korean version of Modified Barthel Index(K-MBI) score

    Time frame: Baseline and Week 4

    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).

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 13, 2022
Registry last updated
May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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