The Electrophysiological Investigation of Higher Level Neural Manifestations of Freezing of Gait in Parkinson's Disease Patient

NCT02214251 | Completed

• 1 other identifier: CMUH103-REC2-017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

We aim to investigate the higher level mechanism of gait disorders in PD patients by ambulatory recording of electroencephalographic (EEG) and leg electromyographic (EMG) signals during unconstrained walking. Independent component analysis will be conducted for signal analysis. The connectivity among different brain regions will also be investigated. The PD patients received deep brain stimulation will be recruited for the study. The local field potentials recorded from sub-thalamic nuclei and/or PPN will be recorded concomitantly with EEG and leg EMG signals during unconstrained walking in PD patients to assess the roles of these deep structures in ambulation and their functional connectivity with other brain regions during walking.

Conditions

Parkinson's Disease; Freezing of Gait

Keywords

Parkinson's disease; freezing of gait; movement disorders; neuroscience; neural; mechanism

Outcome Measures

Primary Outcomes (1)

• Recording of electroencephalographic (EEG) and electromyographic (EMG) signals during unconstrained walking.

  Variables in gait analysis:1.Gait initiation; 2.Level walking; 3.Turning; 4.Gait termination.

  Baseline

Secondary Outcomes (6)

• Unified Parkinson's Disease Rating Scale (UPDRS)

  Baseline

• The 39-item Parkinson's Disease Questionnaire (PDQ-39)

  Baseline

• The Fall Assessment Test of CMUH

  Baseline

• Tinetti Performance Oriented Mobility Assessment (POMA)

  Baseline

• New freezing of gait questionnaire (NFOG-Q)

  Baseline

Study Arms (1)

PK-16CH EXG system

EXPERIMENTAL

PK-16CH EXG is a wireless physiological signal acquisition system for monitoring the bio-signals, such as EEG, ECG, and EMG. The system can concomitant EEG and EMG recording during ambulation.

Device: PK-16CH EXG system

Interventions

PK-16CH EXG system DEVICE

PK-16CH EXG system

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with PD will be diagnosed according to the Brain Bank criteria.

You may not qualify if:

• impairment of cognition that leads unable to fully cooperate with the oral commands during operation.
• any moderate to severe medical disorders such as poor control of diabetic mellitus, functional III or above congestive heart failure, or cancer with distant metastasis etc.
• severe mood disorders such as major depression.

Sponsors & Collaborators

• China Medical University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

China Medical University Hospital/Neuro Depart

Taichung, Taiwan, 40447, Taiwan

Location

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The chief, Department of Neurology

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: August 12, 2014
• Study Start: August 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2016
• Last Updated: July 28, 2016

Record last verified: 2016-07

Locations

TW (1)