Electrophysiological Investigation and rTMS Intervention of Ambulatory Central Processing of Freezing of Gait in Parkinson's Disease
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2013
CompletedFirst Posted
Study publicly available on registry
June 24, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedAugust 8, 2014
January 1, 2014
6 months
June 19, 2013
August 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Laboratory gait analysis after 8 courses of iTBS
Variables in gait analysis:1.Gait initiation; 2.Level walking; 3.Turning; 4.Gait termination.
baseline to week 8
Secondary Outcomes (7)
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 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
- +2 more secondary outcomes
Study Arms (2)
real iTBS
EXPERIMENTALThe paradigm will use a theta burst stimulation pattern (TBS) in which 3 pulses of stimulation will be given at 50Hz, repeated every 200 ms. In the iTBS, a 2-second train of TBS is repeated every 10 seconds for a total of 190 seconds (600 pulses). Subjects will be 8 courses of iTBS stimulation in 10 business days.
sham iTBS
SHAM COMPARATORSubjects will be 8 courses of sham iTBS stimulation in 10 business days.
Interventions
Theta-burst magnetic stimulation (TBS) is a repetitive transcranial magnetic stimulation (rTMS) technique that elicits long-lasting changes in the excitability of human primary motor cortex (M1).
The sham test will be done by transferring the double cone coil 90 degrees anteriorly and putting the lower edge of the coil of the vertex.
Eligibility Criteria
You may qualify if:
- Patients with PD will be diagnosed according to the Brain Bank criteria.
You may not qualify if:
- Patients had past history of epilepsy, intracranial operation or brain tumor.
- Hoehn \& Yahr Stage V.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital/Neuro Depart
Taichung, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- The chief, Department of Neurology
Study Record Dates
First Submitted
June 19, 2013
First Posted
June 24, 2013
Study Start
January 1, 2014
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
August 8, 2014
Record last verified: 2014-01