A Study on Brain Activity During Transcranial Direct Current Stimulation in Stroke Patients

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04549753
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.8
• Patients Per Site Per Month: 10.6

Study Details

Study Description

Brief Summary

The purpose of this study is to identify the characteristics of neural plasticity seen in stroke patients by measuring the changes in brain activity during stimulation using functional near-infrared spectroscopy (fNIRS) when applying transcranial direct current stimulation (tDCS) for the purpose of enhancing finger function.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Transcranial direct current simulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study on Brain Activity During Transcranial Direct Current Stimulation for Improving Finger-Hand Function in Stroke Patients
• Actual Study Start Date: Sep 15, 2020
• Actual Primary Completion Date: Dec 10, 2020
• Actual Study Completion Date: Dec 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tDCS stimulation group Patients receive four sessions of tDCS stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system.	Device: Transcranial direct current simulation; Four sessions of stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system

Outcome Measures

Primary Outcome Measures

1. Changes in cortical activity using fNIRS signals during brain stimulation [Baseline and about 10 days (immediately after brain stimulation sessions)]

   Cortical activities before and after brain stimulation sessions are compared.

Secondary Outcome Measures

1. Changes in motor evoked potential [Baseline and about 10 days (immediately after brain stimulation sessions)]

   Resting motor threshold (rMT) and amplitude of motor evoked potential in first dorsal interosseous muscle are measured. These outcomes are measured by transcranial magnetic stimulation over the motor hotspot. The rMT is defined as the minimum stimulus intensity that produced a minimal motor evoked response at rest. The amplitude means peak to peak of the muscle response.

2. 9-hole pegboard test [Baseline and about 10 days (immediately after brain stimulation sessions)]

   The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.

3. Grip & Tip pinch strength test [Baseline and about 10 days (immediately after brain stimulation sessions)]

   The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.

4. Box & Block test [Baseline and about 10 days (immediately after brain stimulation sessions)]

   The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device.

5. Fugl-Meyer Assessment [Baseline and about 10 days (immediately after brain stimulation sessions)]

   The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured.

6. Finger tapping test [Baseline and about 10 days (immediately after brain stimulation sessions)]

   Response time is measured during finger tapping task.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Unilateral stroke patients

• Chronic patients over 6 months after onset

• Subcortical stroke

• Patients with the movement of fingers

Exclusion Criteria:

• History of psychiatric disease

• Significant other neurological diseases except for stroke

• Difficult to perform this experiment

• Patients with metal implants

• History of epilepsy

• Pregnancy

• Skin defect at the site of electrode attachment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	06351

Sponsors and Collaborators

• Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT04549753
• Other Study ID Numbers: 2020-04-183
• First Posted: Sep 16, 2020
• Last Update Posted: Mar 10, 2021
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Mar 10, 2021