NCT04041661

Brief Summary

To investigate the effect of concurrent transcranial direct current stimulation and gait training on gait performance when doing the cognitive dual-task in people with Parkinson's Disease.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

1.1 years

First QC Date

July 31, 2019

Last Update Submit

August 2, 2019

Conditions

Keywords

Dual task performanceExecutive functionTranscrainal direct current stimulation (tDCS)

Outcome Measures

Primary Outcomes (1)

  • Dual-task walking performance

    To evaluate gait parameters while doing dual-task walking

    Change from baseline at 4 weeks

Secondary Outcomes (4)

  • Single walking performance

    Change from baseline at 4 weeks

  • Trail-making test A & B

    Change from baseline at 4 weeks

  • Stroop color and word test-Chinese version

    Change from baseline at 4 weeks

  • Digit span test

    Change from baseline at 4 weeks

Study Arms (2)

Active tDCS plus gait training group

EXPERIMENTAL

Participants in Active tDCS plus gait training group will execute Active tDCS on left dorsolateral prefrontal cortex which combined with treadmill, 12 times per week, least 4 weeks.

Other: Active tDCS plus gait training

Sham tDCS plus gait training group

SHAM COMPARATOR

Participants in Sham tDCS plus gait training group will executeSham tDCS on left dorsolateral prefrontal cortex which combined with treadmill, 12 times per week, least 4 weeks.

Other: Sham tDCS plus gait training

Interventions

Participants in experimental group will accept Active tDCS which combined with treadmill

Active tDCS plus gait training group

Participants in control group will accept Sham tDCS which combined with treadmill

Sham tDCS plus gait training group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with idiopathic PD
  • Hoehn and Yahr stages I-III
  • Mini Mental Status Examination (MMSE) score ≧ 24
  • Could walk 10m independently with or without gait aid

You may not qualify if:

  • Concurrent medication likely to affect mental performance
  • tDCS contraindication
  • Significant neurological, vestibular, visual disorders or psychiatric illness
  • Musculoskeletal or cardiopulmonary disease
  • Sensory system pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yearu Yang, Ph.D

CONTACT

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

July 31, 2019

First Posted

August 1, 2019

Study Start

August 1, 2019

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

August 6, 2019

Record last verified: 2019-08