NCT04699331

Brief Summary

This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation-based individualized stimulation compared to conventional stimulation and sham stimulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jan 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

January 5, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

January 29, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2022

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

1.9 years

First QC Date

January 5, 2021

Last Update Submit

February 1, 2023

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Changes in motor evoked potential

    Resting motor threshold (rMT), amplitude, and latency of motor evoked potential in the 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. The latency is defined as the time point from the onset of the stimulus to the onset of MEP.

    Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)

Secondary Outcomes (6)

  • Jebsen-Taylor hand function test

    Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)

  • 9-hole peg test

    Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)

  • Grip & Tip pinch strength test

    Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)

  • Box & Block test

    Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)

  • Fugl-Meyer Assessment

    Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)

  • +1 more secondary outcomes

Study Arms (3)

Individualized stimulation group

EXPERIMENTAL

Patients receive five sessions of individualized stimulation obtained from brain image-based transcranial direct stimulation simulation. The simulator generates the electrode's location on the scalp.

Device: Transcranial Direct Current Stimulation

Conventional stimulation group

ACTIVE COMPARATOR

Patients receive five sessions of conventional stimulation with electrodes over C3 and C4 based on the 10-20 system.

Device: Transcranial Direct Current Stimulation

Sham stimulation group

SHAM COMPARATOR

Patients receive five sessions of sham stimulation with electrodes over C3 and C4 based on the 10-20 system.

Device: Transcranial Direct Current Stimulation

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.

Conventional stimulation groupIndividualized stimulation groupSham stimulation group

Eligibility Criteria

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

You may qualify if:

  • Unilateral stroke patients
  • Chronic patients over 6 months after onset
  • Patients with motor evoked potential of the first dorsal interosseous muscle
  • 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
Professor

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 7, 2021

Study Start

January 29, 2021

Primary Completion

December 23, 2022

Study Completion

December 23, 2022

Last Updated

February 3, 2023

Record last verified: 2023-02

Locations

KR(1)