NCT03271736

Brief Summary

Patients with Parkinson's disease have internal rhythm dysfunction, which may affect the rhythmic movements such as walking. Poor regularity of the rhythmic movement may lead to freezing of gait. This study will apply rhythmic auditory cues on the stepping-in-place training and the investigators will examine if the behavior and neuroelectrophysiology would change after auditory cueing training. The investigators hypothesize the variation of rhythmic movements such as walking and stepping-in-place will be reduced, and the cortical excitability would be modulated after training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

February 8, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

August 6, 2017

Last Update Submit

March 29, 2019

Conditions

Parkinson Disease

Keywords

Parkinson's diseaseAuditory cuesstep in placetranscranial magnetic stimulationcortical excitability

Outcome Measures

Primary Outcomes (1)

  • Changes of transcranial magnetic stimulation (TMS) parameters

    Single-pulse and paired-pulse TMS are used to measure the cortical excitability of the motor cortex and the integrity of the intracortical inhibitory/facilitatory circuits. The TMS parameters include motor threshold (MT), motor evoke potential, silent period, short intracortical inhibition and facilitation. In single-pulse condition, the stimulation intensity is set at 130% of the MT. While in the paired-pulse condition, the first conditioning stimulus is set at 80% of MT, the second test stimulus is set at 130% of MT.

    TMS parameters are assessed immediately before and after a 30-minute intervention. The data will be reported through study completion, for average of 6 months.

Secondary Outcomes (3)

  • Variation of walking step time

    The step time variability is assessed immediately before and after a 30-minute intervention. The data will be reported through study completion, for average of 6 months.

  • Walking ability

    The walking ability is assessed immediately before and after a 30-minute intervention. The data will be reported through study completion, for average of 6 months.

  • Variation of stepping-in-place movement

    The step variability is assessed immediately before and after a 30-minute intervention. The data will be reported through study completion, for average of 6 months.

Study Arms (2)

Freezer

EXPERIMENTAL

All the subjects received 2 experiments. 2 experiments contain 20 mins stepping-in-place exercise and pre-/post assessments. The difference between 2 experiments is the application of auditory cues. One of the 2 experiment includes stepping-in-place exercise with auditory cues from the metronome (Stepping-in-place exercise with external auditory cues), in the other experiment we ask the subjects to follow their internal rhythm without external auditory cues (Stepping-in-place exercise without external auditory cues). Transcranial magnetic stimulation (TMS) is applied before and after the stepping-in-place exercise.

Behavioral: Stepping-in-place exercise with external auditory cuesDevice: Transcranial magnetic stimulation (TMS)

Non-freezer

EXPERIMENTAL

All the subjects received 2 experiments. 2 experiments contain 20 mins stepping-in-place exercise and pre-/post assessments. The difference between 2 experiments is the application of auditory cues. One of the 2 experiment includes stepping-in-place exercise with auditory cues from the metronome (Stepping-in-place exercise with external auditory cues), in the other experiment we ask the subjects to follow their internal rhythm without external auditory cues (Stepping-in-place exercise without external auditory cues). Transcranial magnetic stimulation (TMS) is applied before and after the stepping-in-place exercise.

Behavioral: Stepping-in-place exercise with external auditory cuesDevice: Transcranial magnetic stimulation (TMS)

Interventions

Stepping-in-place exercise with external auditory cuesBEHAVIORAL

The stepping-in-place exercise includes 10-session training. In each session, subjects are asked for stepping for 50 steps. In auditory cued condition, the cued frequency is set at 110% of the usual walking cadence. While in non-cued condition, we ask the subjects to step according to their own internal rhythm.

Also known as: Stepping-in-place exercise without external auditory cues
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Transcranial magnetic stimulation (TMS)DEVICE

TMS is used to assess the cortical excitability of the motor cortex. The stimulation intensity is set at 130% of the motor threshold in single-pulse condition. In paired-pulse condition, the first stimulus is set at 80% of the motor threshold and the second stimulus is set at 130% of the motor threshold.

FreezerNon-freezer

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with idiopathic Parkinson's disease
  • No hearing impairment
  • Able to walk independently for at least 10m
  • Able to follow command (MMSE \>=24)
  • \[Healthy subjects\]
  • No hearing impairment
  • Able to walk independently for at least 10m
  • Able to follow command (MMSE \>=24)

You may not qualify if:

  • With other neurological diseases or psychological diseases
  • Dementia
  • Family history of epilepsy
  • History of head trauma, surgery, or metal implants
  • Having pacemaker or other electrical stimulators
  • History of syncopes or frequent migraines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of physical therapy, National Taiwan University

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Jau Yih Tsauo, PT, phD

    department of physical therapy, college of medicine, National Taiwan University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 6, 2017

First Posted

September 5, 2017

Study Start

February 8, 2018

Primary Completion

May 30, 2018

Study Completion

June 30, 2018

Last Updated

April 2, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)