Clinical trial NCT01884493: Electrophysiological Investigation and rTMS Intervention of Ambulatory Central Processing of Freezing of Gait in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Parkinson's Disease
Parkinson's Disease With Freezing of Gait
Keywords: Parkinson's Disease
Freezing of Gait
movement-related cortical potential
repetitive transcranial magnetic stimulation
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2013-06-24
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Laboratory gait analysis after 8 courses of iTBS
timeFrame: baseline to week 8
Secondary outcomes:
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) after 8 courses of iTBS
timeFrame: baseline to week 8
measure: Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) after 8 courses of iTBS
timeFrame: baseline to week 8
measure: Change in Fall assessment test after 8 courses
timeFrame: baseline to week 8
measure: Change in Tinetti's Mobility Index after 8 courses of iTBS
timeFrame: baseline to week 8
measure: Change in new freezing of gait questionnaire (FOG-Q) after 8 courses
timeFrame: baseline to week 8
measure: Change in Patients' Global Impressions of Change (PGIC) Scale after 8 courses of iTBS
timeFrame: baseline to week 8
measure: Change in Clinical Global Impressions (CGI) after 8 courses of iTBS
timeFrame: baseline to week 8
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital/Neuro Depart
Study officials:
References: