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

NCT ID: NCT02214251

Last Updated: 2016-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-07-31

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.

Detailed Description

Gait disorder in Parkinson's disease (PD) contains several aspects including particularly the slowness of walking and freezing of gait (FOG). These problems may sometimes cause fall of patients and culminate in severe head injury and bony fracture. In this regard the understanding of freezing of gait and other parkinsonian ambulatory disorders is important for the management of patients. Previous electrophysiological studies of gait disorders were majorly focused on the kinetic and kinematric measurements. How the higher level neural structures including the cerebral cortex, basal ganglia, sub-thalamic nucleus or pedunculopontine nucleus were involved in the gait processing are currently unknown. A recent study by adopting movement related cortical potential (MRCP) recording to probe the PD ambulatory disorders in freezing and non-freezing patients illustrated that PD patients with FOG lost the relationship between stride length and the movement related potentials. Since the study was performed in constrained condition and each trigger for MRCP did not guarantee to be of freezing nature in FOG patients, the results cannot reflect the true manifestations of gait freezing in PD patients. In the current proposal, we will perform concomitant recording of the scalp electroencephagraphic and leg electromyographic signals during unconstrained walking in normal subjects and PD with or without FOG. Independent component analysis (ICA) will be conducted for analyzing the possible differences of patterns among the three groups and within the FOG patients during the freezing and non-freezing phases. In addition, the cortical effective connectivity among different cortical regions during freezing and non-freezing phase will also be assessed. Since sub-thalamic nuclei and pedunculopontine nucleus may be involved in the ambulatory circuitry, we will also investigate this possibility in PD patients to be treated with deep brain stimulation. The nuclear local field potentials will be recorded concomitantly with scalp electroencephalographic signals and electromyographic signals during unconstrained signals. ICA and event related de-synchronization analysis will be conducted to understand the roles of these nuclei in walking. The effective connectivity of the deep nuclei and the cortical regions will also be assessed to learn the functional set of ambulation. The pioneer exploration of the higher level neural manifestations of walking will extend the spectrum from conventional kinetic and kinematric gait analysis to peep how the central neural circuitry operate in ambulation.

Conditions

Parkinson's Disease; Freezing of Gait

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

PK-16CH EXG system

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.

Group Type: EXPERIMENTAL

PK-16CH EXG system

Intervention Type: DEVICE

Interventions

PK-16CH EXG system

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

1. impairment of cognition that leads unable to fully cooperate with the oral commands during operation.

2. 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.

3. severe mood disorders such as major depression.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chon-Haw Tsai

The chief, Department of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

China Medical University Hospital/Neuro Depart

Taichung, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

CMUH103-REC2-017

Identifier Type: -

Identifier Source: org_study_id