NCT04903457

Brief Summary

This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation on motor learning to stroke patients compared to sham stimulation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

June 17, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

May 23, 2021

Last Update Submit

February 27, 2023

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Assessment

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

    Baseline, immediately after five brain stimulation sessions

Secondary Outcomes (7)

  • Changes in cortical activity using fNIRS signals during brain stimulation

    Baseline, during, immediately after five brain stimulation sessions

  • Changes in motor evoked potential

    Baseline, immediately after five brain stimulation sessions

  • 9-hole pegboard test

    Baseline, immediately after five brain stimulation sessions

  • Grip & Tip pinch strength test

    Baseline, immediately after five brain stimulation sessions

  • Box & Block test

    Baseline, immediately after five brain stimulation sessions

  • +2 more secondary outcomes

Other Outcomes (2)

  • Resting-state functional MRI

    Baseline (Before stimulation sessions)

  • Changes in cortical activity using fNIRS signals.

    Baseline (Before stimulation sessions)

Study Arms (2)

Real stimulation before motor learning training

EXPERIMENTAL

Patients receive five sessions of tDCS stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system immediately before sequential finger tapping task.

Device: Transcranial Direct Current StimulationBehavioral: Motor learning

Sham stimulation before motor learning training

ACTIVE COMPARATOR

Patients receive five sessions of sham stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system immediately before sequential finger tapping task.

Behavioral: Motor learning

Interventions

Transcranial Direct Current StimulationDEVICE

Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.

Real stimulation before motor learning training
Motor learningBEHAVIORAL

Sequential finger tapping task training is applied to stroke patients.

Real stimulation before motor learning trainingSham stimulation before motor learning training

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral stroke including basal ganglia lesion patients
  • Chronic patients over 6 months after onset
  • Patients with the movement of fingers

You may not qualify if:

  • History of psychiatric disease
  • Significant other neurological diseases except for stroke
  • Difficult to perform this experiment
  • Patients who are deemed difficult to participate in this research by the investigator
  • Patients with metal implants and medical devices
  • History of epilepsy
  • Pregnancy
  • Skin defect at the site of electrode attachment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 23, 2021

First Posted

May 26, 2021

Study Start

June 17, 2021

Primary Completion

June 14, 2022

Study Completion

December 31, 2022

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations

KR(1)