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Clinical Trials/NCT03271736
NCT03271736
Completed
Not Applicable

Effects of Rhythmic Auditory Cueing on Stepping in Place in Patients With Parkinson's Disease

HsiuYun Chang1 site in 1 country21 target enrollmentFebruary 8, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
HsiuYun Chang
Enrollment
21
Locations
1
Primary Endpoint
Changes of transcranial magnetic stimulation (TMS) parameters
Status
Completed
Last Updated
7 years ago

Overview

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.

Detailed Description

Parkinson's disease is a common neurodegenerative disease and movement disorder. Due to the degeneration of basal ganglia, patients with Parkinson's disease also demonstrate internal rhythm dysfunction, thus will lead to difficulty in rhythmic movements such as ambulation. For improving the rhythmic movement problem, auditory cues are often used in clinical setting and shows benefits in ambulation and freezing problems. Previous studies often use finger tapping test and ambulation to assess the rhythmic movement problem. No study uses stepping in place movements as a test to examine rhythmic problem. Little study investigates the effects of auditory cues on brain cortical excitability. In this cross-over study, participants will receive 2 times of training include stepping-in-place exercise with and without auditory cues in random orders. Auditory cues are given via the metronome. There is one-week wash-out period between two trainings. Movement tests such as walking and stepping-in-place and transcranial magnetic stimulation (TMS) are carried out before and after each training. The investigators hypothesize the variation of rhythmic movements such as walking and stepping-in-place will be reduced more, and the cortical excitability would be modulated after the training with auditory cues, comparing with the other training without auditory cues.

Registry
clinicaltrials.gov
Start Date
February 8, 2018
End Date
June 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
HsiuYun Chang
Responsible Party
Sponsor Investigator
Principal Investigator

HsiuYun Chang

Principal Investigator

National Taiwan University

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

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

Outcomes

Primary Outcomes

Changes of transcranial magnetic stimulation (TMS) parameters

Time Frame: 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.

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.

Secondary Outcomes

  • 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.)
  • 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.)
  • 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.)

Study Sites (1)

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