NCT05275114

Brief Summary

The purpose of this study was to improve the effect of Transcranial Direct Current Stimulation (tDCS) applied during exercise training in stroke patients with upper limb and hand motor function.

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 Mar 2022

Shorter than P25 for not_applicable stroke

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

March 1, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 11, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

March 1, 2022

Last Update Submit

September 20, 2022

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Change in Fugl-Meyer Assessment

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

    Session 0 (initial visit);; Session 10 (at approximatel 4 weeks)

Secondary Outcomes (7)

  • Change in 9-hole pegboard test

    Baseline(initial visit); Session 10 (at approximatel 4 weeks)

  • Change in Grip & Tip pinch strength

    Baseline(initial visit); Session 10 (at approximatel 4 weeks)

  • Change in Sequential finger tapping reaction time and accruacy

    Baseline(initial visit); Session 10 (at approximatel 4 weeks)

  • Change in Jebsen-Taylor hand function test

    Baseline(initial visit); Session 10 (at approximatel 4 weeks)

  • Change in Box and Block test

    Baseline(initial visit); Session 10 (at approximatel 4 weeks)

  • +2 more secondary outcomes

Study Arms (2)

Hand Tasks + M1(1mA) & aIPS(1mA) tDCS

EXPERIMENTAL

20 minutes of Hand Taks + applying 30 minutes of M1(1mA) \& aIPS(1mA) tDCS and fNIRS

Device: tDCS stimulation with hand task

Hand Tasks + Sham tDCS

ACTIVE COMPARATOR

20 minutes of Hand Tasks + 30 minutes of sham tDCS and fNIRS

Device: sham tDCS stimulation with hand task

Interventions

tDCS stimulation with hand taskDEVICE

30 minutes of intervention including tDCS stimulation with hand task and fNIRS measurements for 10 days in 4 weeks

Hand Tasks + M1(1mA) & aIPS(1mA) tDCS
sham tDCS stimulation with hand taskDEVICE

30 minutes of intervention including sham tDCS stimulation with hand task and fNIRS measurements for 10 days in 4 weeks

Hand Tasks + Sham tDCS

Eligibility Criteria

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

You may qualify if:

  • Patients aged 19 to 80 years
  • Less than 58 FMA Upper scores
  • Patients whose lesions do not include stimulation regions
  • Patients with stroke with more than 3 months of onset

You may not qualify if:

  • Difficult to communicate due to severe language impairment.
  • Accompanied by an existing serious neurogenic disease
  • Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder
  • If there are difficulties in conducting the research
  • Any patients who are judged by the investigator to be difficult to participate in this study
  • Patients with contraindicated MRI scans

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (1)

  • Lee SH, Lee G, Kim J, Phillips V Z, Kim H, Kim E, Lee SH, Jeong HC, Paik SH, Kim YH, Kim BM. Resting-state hemodynamic changes and effects on upper limb function after multi-channel transcranial direct current stimulation to the ipsilesional primary motor cortex and anterior intraparietal sulcus in stroke patients: an fNIRS pilot study. J Neuroeng Rehabil. 2025 Apr 16;22(1):83. doi: 10.1186/s12984-025-01618-8.

    PMID: 40241110DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 1, 2022

First Posted

March 11, 2022

Study Start

March 11, 2022

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

September 21, 2022

Record last verified: 2022-09

Locations

KR(1)