NCT04591236

Brief Summary

The purpose of this study was to investigate the effect of simultaneous application of transcranial direct current stimulation (tDCS) and treadmill gait training for gait function recovery in Parkinson's disease patients with gait impairment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable parkinson-disease

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

October 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

November 3, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2021

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

October 15, 2020

Last Update Submit

February 27, 2023

Conditions

Parkinson Disease

Keywords

transcranial direct current stimulationgait trainingParkinson's disease

Outcome Measures

Primary Outcomes (1)

  • Change in 10 meter walk test from baseline in gait speed

    Measure of self selected speeds by measuring the time it takes an individual to walk 10 meters. To perform the test, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go."

    session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]

Secondary Outcomes (9)

  • Change in Berg Balance Scale (BBS) from baseline in balance

    session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]

  • Change in Timed Up and Go test (TUG) from baseline in balance

    session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]

  • Changes in Brain activation of resting-state functional MRI

    session 0 (initial visit); session 10 (at approximately 4 weeks)

  • Changes in motor evoked potentia

    session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]

  • Changes in Functional Reach Test (FRT) from baseline

    session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]

  • +4 more secondary outcomes

Study Arms (2)

Gait training with brain stimulation

EXPERIMENTAL

Treadmill gait training and transcranial direct current stimulation (tDCS) on the leg motor areas

Device: Brain stimulationDevice: Treadmill gait training

Gait training with sham brain stimulation

ACTIVE COMPARATOR

Treadmill gait training and anodal sham transcranial direct current stimulation (tDCS) on the leg motor areas

Device: Treadmill gait training

Interventions

Brain stimulationDEVICE

tDCS brain stimulation on leg motor areas was applied to Parkinson patients.

Gait training with brain stimulation
Treadmill gait trainingDEVICE

Treadmill gait training was applied to Parkinson patients.

Gait training with brain stimulationGait training with sham brain stimulation

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 50 - 75 years
  • Modified Hoehn and Yahr stages 1 to 4

You may not qualify if:

  • Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
  • Difficult to understand experimental tasks because of extremely severe cognitive impairment (Korean-Mini-Mental State Examination, K-MMSE≤10)
  • History of psychiatric disease
  • Implanted objects that would contraindicate tDCS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Yun-Hee Lee, Ph.D

    yun1225.kim@samsung.com

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 19, 2020

Study Start

November 3, 2020

Primary Completion

May 31, 2021

Study Completion

June 18, 2021

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations

KR(1)