A clinical trial of improving upper extremity function, including the fingers on the paretic side, when applying transcranial direct current stimulation therapy during upper extremity exercise therapy in stroke patients

A multicenter, randomized, parallel design, double-blind, superiority test, prospective confirmatory clinical trial to confirm the safety and effectiveness of improving upper extremity function, including the fingers on the paretic side, when applying transcranial direct current stimulation therapy during upper extremity exercise therapy in stroke patients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010556

Enrollment

Registered

2025-05-28

Start date

2024-09-20

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : 1) Number of subjects: 64 in total (32 in the control group, 32 in the test group) 2) Applied device: NT Brain 48CH neurostimulator 3) Application period: 40 minutes per session, 3 ti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adult men and women aged 19 to 80 years 2) Patients with unilateral stroke confirmed by CT or MRI 3) Patients who have passed 3 months or more since the date of diagnosis by CT or MRI 4) Those with unilateral upper limb dysfunction with a Fugl-Meyer Assessment upper extremity score (FMA-UE) of 25 to 58 points

Exclusion criteria

Exclusion criteria: 1) If there is a serious neurological disorder other than stroke 2) If there is a serious mental disorder such as schizophrenia or bipolar disorder 3) If the K-MMSE score is less than 18 points* 4) If botox or nerve block was received in the upper limb within 1 month from the date of consent 5) If surgical treatment has been performed on the peripheral nerves, muscles, and tendons of the upper limb 6) If it is within 1 month from the date of consent after the end of participation in another clinical trial 7) If the principal investigator or researcher determines that the medications being administered may have a significant impact on the efficacy assessment results during the study, or if the patient is scheduled to receive treatment 8) If the patient is not suitable for transcranial direct current stimulation 1. Patients with electronic medical devices implanted in the body, such as electrocardiographs, internal implants, or artificial heart-lung machines 2. Patients with metal objects inserted into the skull 3. Patients with wounds on the skin at the attachment site 4. Patients with uncontrolled epileptic seizures 5. Pregnant or lactating women * Patrizio Pezzotti et al. (2008) The accuracy of the MMSE in detecting cognitive impairment when administered by general practitioners: A prospective observational study. BMC Fam Pract 9:29 doi: 10.1186/1471-2296-9-29

Design outcomes

Primary

Measure	Time frame
Fugl-Meyer Assessment Scale – Upper motor score(FMA-UE)	—

Secondary

Measure	Time frame
9-hole pegboard test (hand function test);Grip & Tip pinch strength (hand function test);Sequential finger tapping reaction time and accuracy;SF-36 ;Box and block test (hand function test)	—

Countries

Korea, Republic of

Contacts

Public ContactSEUNG-ROK KANG

Jeonbuk National University Hospital

srkang@mdctc.or.kr+82-63-259-3458

Outcome results