Clinical trial NCT03656796: Effects of RAC With Locomotion Training on Cortical Excitability and Behavior in Patients With PD
Official title: Effects of Rhythmic Auditory Cueing With Locomotion Training on Cortical Excitability and Behavior in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: PD
Auditory cueing
TMS
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 29
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: Background: 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. To improve the rhythmic movement problems, auditory cues are often used in clinical setting and have been revealed providing benefits in ambulation and freezing problems for PD subjects. Besides, treadmill training is another common intervention to improve gait performance for PD. However, lack studies investigate the effects of auditory cues with locomotion training on brain neurophysiology and scarcer studies investigate the different effects of auditory cues between the freezers and non-freezers.

Objective: To investigate the effects of auditory-cued training on cortical excitability and motor performances in patients with PD. To investigate whether different effects of auditory cues on cortical excitability and motor performance between the freezers and non-freezers.

Methods: We will recruit 17 freezers, 17 non-freezers and 17 healthy elderly. Each participants will receive the trainings under two conditions in random order. There is one week wash-out period between two-trainings. Two-training are (1) treadmill training with concurrent auditory cues: participants should walk on the treadmill according to the rhythmic auditory cues (110% step frequency) for 30 min. (2) treadmill training without any auditory cues: participants should walk in comfortable speed on the treadmill for 30 min. Assessments consist of cortical excitability through transcranial magnetic stimulation (TMS), stepping-in-place test, and walking test, and they will be done before and after training.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Transcranial magnetic stimulation (TMS)
timeFrame: 40 min
Secondary outcomes:
measure: 10 meter walking test
timeFrame: 10 min
measure: Stepping-in-place test
timeFrame: 5 min
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhong Cheng
Study officials:
affiliation: National Taiwan University
name: Jer-Junn Luh, PhD
role: PRINCIPAL_INVESTIGATOR
References: