The Effect of tDCS Based on Functional Brain Imaging for Subacute Stroke Patients

Samsung Medical Center

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Hand motor task; Device: Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05142917

2021-10-092-001

Details and patient eligibility

About

The purpose of this study is to investigate whether brain imaging-based hand function area tDCS stimulation is more effective than conventional stimulation or sham stimulation for improving hand motor function.

Enrollment: 12 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unilateral stroke patients aged 19 to 80 years
• Patients with subacute stroke within 4 weeks of onset
• Patients with moderate or severe upper extremity dysfunction with an upper extremity FMA score of less than 58 in motor function evaluation

Exclusion criteria

• Accompanied by an existing serious neurogenic disease

• Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder, and dementia.

• If there are difficulties in conducting the research

• Any patients who are judged by the investigator to be difficult to participate in this study

• Exclusion criteria for transcranial direct current stimulation:

  i) Patients with implanted medical devices in the body (e.g. pacemakers) ii) When a metal object is inserted in the skull iii) If there is a wound on the skin of the attachment site iv) history of epilepsy v) Pregnant and lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 3 patient groups

fNIRS based hand motor area real stimulation

Experimental group

Description:

Real stimulation is applied to functional brain image-based hand function area (20 minutes) and then hand motor task (20 minutes).

Treatment:

Device: Transcranial Direct Current Stimulation

Behavioral: Hand motor task

Traditional hand motor area real stimulation

Active Comparator group

Description:

Real stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes).

Treatment:

Device: Transcranial Direct Current Stimulation

Behavioral: Hand motor task

Traditional hand motor area sham stimulation

Sham Comparator group

Description:

Sham stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes).

Treatment:

Behavioral: Hand motor task