NCT03656796

Brief Summary

In this study, 51 subjects include 17 freezers,17 non-freezers and 17 aged-matched healthy subjects will be recruited. We will compare the cortical excitability, gait performance, and stepping-in-place performance before and after intervention of auditory cues combined with gait training. The cortical excitability will be assessed by transcranial magnetic stimulation (TMS). The purpose in this study is to investigate the effects of auditory cues with gait training on cortical excitability and rhythmic movements in patients with Parkinson's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2019

Completed
Last Updated

September 25, 2019

Status Verified

March 1, 2019

Enrollment Period

3 months

First QC Date

August 30, 2018

Last Update Submit

September 24, 2019

Conditions

Parkinson's Disease

Keywords

PDAuditory cueingTMS

Outcome Measures

Primary Outcomes (1)

  • Transcranial magnetic stimulation (TMS)

    TMS will be used to evaluate the cortical excitability. TMS parameters include resting motor threshold (RMT), motor evoke potential (MEPs), cortical silent period (CSP), short intracortical inhibition (SICI) and intracortical facilitation (ICF)

    40 min

Secondary Outcomes (2)

  • 10 meter walking test

    10 min

  • Stepping-in-place test

    5 min

Study Arms (3)

PD with freezing of gait (FOG)

EXPERIMENTAL

Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).

Other: Treadmill training with auditory cuesOther: Treadmill training without auditory cues

PD without freezing of gait (FOG)

EXPERIMENTAL

Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).

Other: Treadmill training with auditory cuesOther: Treadmill training without auditory cues

Healthy subjects (Control)

EXPERIMENTAL

Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).

Other: Treadmill training with auditory cuesOther: Treadmill training without auditory cues

Interventions

Treadmill training with auditory cuesOTHER

Participants should walk on the treadmill according to the rhythmic auditory cues (110% step frequency) for 30 min

Also known as: AC
Healthy subjects (Control)PD with freezing of gait (FOG)PD without freezing of gait (FOG)
Treadmill training without auditory cuesOTHER

Participants should walk in comfortable speed on the treadmill for 30 min.

Also known as: NC
Healthy subjects (Control)PD with freezing of gait (FOG)PD without freezing of gait (FOG)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged above 20 y/o
  • Diagnosed with idiopathic Parkinson's disease
  • No hearing impairment
  • Able to walk independently without aid
  • MMSE above 24

You may not qualify if:

  • Other neurological disease
  • Orthopedic problems affect gait performance
  • Psychological disorder
  • Unstable cardiovescular and respiratory status
  • Dementia
  • Visual disturbance affects gait performance
  • Contraindication of transcranial magnetic stimulation: family history of epilepsy; head injury; head surgery or metal implant; pacemaker; syncope or migraine with unknown reasons; pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhong Cheng, 100, Taiwan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jer-Junn Luh, PhD

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 4, 2018

Study Start

April 23, 2018

Primary Completion

July 9, 2018

Study Completion

April 2, 2019

Last Updated

September 25, 2019

Record last verified: 2019-03

Locations

TW(1)