NCT04830631

Brief Summary

Patients with chronic stroke (\>6 months after stroke) having unilateral upper limb hemiparesis will be recruited. Patients will maintain their usual inpatient rehabilitation including occupational therapy. At baseline (T0) and after 2weeks of enrollment (T1), Fugl-Meyer assessment (FMA) will be assessed at each time. And patients with the changes of FMA between T0 and T1 less than 3 points will be finally recruited. The enrolled patients will receive additional 30-min cathodal transcranial direct current stimulation (tDCS) over the contralesional motor cortex for 10 consecutive weekdays, with maintaining their usual conventional rehabilitation. At T1 and immediately after 10-seessions of tDCS (T2) and 1 month after completing 10-tDCS session (T3), FMA, Actional Research Arm Test (ARAT), Box and Block Test (BBT) and electroencephalography (EEG) were measured.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Study Start

First participant enrolled

July 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

3.7 years

First QC Date

March 31, 2021

Last Update Submit

May 15, 2022

Conditions

StrokeRehabilitationTranscranial Direct Current StimulationMotor Recovery

Outcome Measures

Primary Outcomes (1)

  • Changes in Fugl-Meyer Assesment Score 1

    Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)

Secondary Outcomes (7)

  • Changes in Fugl-Meyer Assesment Score 2

    Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS)

  • Changes in Action Research Arm Test Score 1

    Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)

  • Changes in Action Research Arm Test Score 2

    Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS)

  • Changes in Box and Block Test Score 1

    Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)

  • Changes in Box and Block Test Score 2

    Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS)

  • +2 more secondary outcomes

Interventions

Cathodal transcranial direct current stimulation (tDCS) over the contralesional motor cortexDEVICE

Cathodal tDCS will be applied to the contralesional motor cortex with 2mA intesntisy for 30 mins/day. Total 10 sessions will be applied.

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic stroke patients with unilateral hemiparesis

You may qualify if:

  • age ranges from 19 to 85 yrs old
  • stroke patients with unilateral hemiparesis
  • st ever stroke
  • chronic stroke (\>6 months after stroke)

You may not qualify if:

  • recurrent stroke
  • history of traumatic brain injury
  • Minimental state examination score is 15 or less.
  • Unstable medical conditions
  • Severe delirium, disorders of consciousness
  • pregnancy
  • can not attach tDCS electrode on the scalp due to skin conditions
  • can not maintain the sitting position
  • intracranial metals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Rusk Rehabilitation Hospital

Seongnam-si, Please Select, 13620, South Korea

RECRUITING

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

Central Study Contacts

Won-Seok Kim

CONTACT

+82317877735wondol77@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 5, 2021

Study Start

July 1, 2020

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

May 17, 2022

Record last verified: 2022-05

Locations

KR(2)