Electrophysiological Investigation and rTMS Intervention of Ambulatory Central Processing of Freezing of Gait in Parkinson's Disease

Not Applicable

Withdrawn

• Conditions: Parkinson's Disease With Freezing of Gait; Parkinson's Disease

• Registration Number: NCT01884493
• Lead Sponsor: China Medical University Hospital

Brief Summary

The gait symptoms are usually refractory to the dopaminergic agents and some other resolutions, i.e. repetitive transcranial magnetic stimulation (rTMS) should be searched for in this regard. To study the impact of rTMS, investigators will adopt a domestically developed ambulatory recorder (PK-16CH EXG) for the concomitant recording of the electroencephalographic and electromyographic signals for PD patients when walking in the gait laboratory or when conducting leg dorsiflexion movement on sitting.

Detailed Description

The Bereitschaftspotential (BP), event related synchronization (ERS) and event related dysynchronization (ERD) will be analyzed for the investigation of the possible differences of brain activities prior to leg voluntary movement between patients and controls. In addition, the synchronized recorded gait parameters for gait ignition,turning and termination will also be analyzed. The information gathered will allow us to further understand the pathophysiology of the gait freezing in PD. Investigators will deliver a course of rTMS with intermittent theta burst paradigm of the leg motor cortex to investigate whether the non-invasive brain stimulation can ameliorate the gait freezing in PD patients. The subjects will be assessed before and 4 times after rTMS during an 8-week period with clinical scoring batteries and electrophysiological recording as aforementioned. At the end of the 8th week, the test group and sham group will cross over and undergo the same procedures as aforementioned. The serial comprehensive investigations in this project will not only promote our understanding of the gait freezing pathophysiology but also may charge a novel trail for the management of long suffering symptom of the PD patients.

Study Timeline

• Study First Submitted: 2013-06-19
• Study First Submitted QC: 2013-06-19
• Study First Posted: 2013-06-24
• Status Verified: 2014-01
• Study Start: 2014-01
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-08-06
• Last Update Posted: 2014-08-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

1. Patients had past history of epilepsy, intracranial operation or brain tumor.
2. Hoehn & Yahr Stage V.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in Laboratory gait analysis after 8 courses of iTBS	baseline to week 8	Variables in gait analysis:1.Gait initiation; 2.Level walking; 3.Turning; 4.Gait termination.

Secondary Outcome Measures

Name	Time	Method
Change in Tinetti's Mobility Index after 8 courses of iTBS	baseline to week 8
Change in new freezing of gait questionnaire (FOG-Q) after 8 courses	baseline to week 8
Change in Clinical Global Impressions (CGI) after 8 courses of iTBS	baseline to week 8
Change in Unified Parkinson's Disease Rating Scale (UPDRS) after 8 courses of iTBS	baseline to week 8
Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) after 8 courses of iTBS	baseline to week 8
Change in Fall assessment test after 8 courses	baseline to week 8
Change in Patients' Global Impressions of Change (PGIC) Scale after 8 courses of iTBS	baseline to week 8

Trial Locations

Locations (1)

China Medical University Hospital/Neuro Depart; 🇨🇳 Taichung, Taiwan