Parkinson's Disease, Parkinson's Disease With Freezing of Gait
Conditions
Keywords
Parkinson's Disease, Freezing of Gait, movement-related cortical potential, repetitive transcranial magnetic stimulation
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.
Interventions
DEVICEsham iTBS
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.
DEVICEreal iTBS
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).
Sponsors
National Science and Technology Council, Taiwan
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 Unified Parkinson's Disease Rating Scale (UPDRS) after 8 courses of iTBS | baseline to week 8 |
| Change in Patients' Global Impressions of Change (PGIC) Scale after 8 courses of iTBS | baseline to week 8 |
| Change in Clinical Global Impressions (CGI) 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 |
Countries
Taiwan
Outcome results
None listed