Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Freezing of gait (FoG) is defined as a brief, episodic absence or reduction of forward progression of the feet despite the intention to walk. It is one of the most disabling and intractable motor symptoms in patients with Parkinson's disease (PD) as it often causes falls and loss of independence. The pathophysiology of FoG remains unclear but it seems differ from other cardinal motor symptoms in PD. The therapeutic efficacy of medical and surgical treatments for FoG are usually suboptimal. Deep brain stimulation (DBS) in the subthalamic nucleus (STN) is a well established treatment for advanced PD with motor fluctuation. It alleviates tremor, bradykinesia and rigidity and improved the quality of life. However, the therapeutic effects of DBS are impeded by high cost of device, stimulation induced adverse effects and partial treatment for some parkinsonism symptoms, particular gait disturbance and FoG. Recently, a new mode of stimulation is proposed. Differing from the conventional DBS which is operated in open loop so that stimulation remains fixed over time and is delivered at regular and high frequencies, the new adaptive DBS (aDBS) detects the pathological activities and only deliver stimulation when it is necessary. Recent studies in MPTP-primate and patients with PD demonstrate that the aDBS is superior to standard continuous DBS. However, the therapeutic efficacy is only shown in "appendicular symptoms" such as bradykinesia, rigidity and tremor. There is no report about the effect of aDBS on gait disturbance, particular FoG in PD so far.
The aim of the current project is to test whether the therapeutic efficacy of aDBS is superior to conventional DBS in PD patients with FoG. To this end, 20 advanced PD patients who undergo STN DBS implantation for the treatment of their disorders will be examined. The gait of patients will be assessed during conventional open loop stimulation and aDBS and the therapeutic efficacy for FoG will be defined. The results of this study will also contribute to better understanding of pathophysiology of FoG and to future development of embedded aDBS system for PD.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD patient who have FoG | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuro Omega | Device | A neurophysiological navigation system NeuroOmegaTM (Alpha Omega. Israel) was implemented in our group and the operation of this system for aDBS experiment is proved to be successful (Fig 9, 10). This system was proved by both FDA and tFDA. The aDBS stimulation algorithm will be integrated with NeuroOmegaTM. The aDBS stimulation control will achieve through self-developed algorithms or built-in scripting of the system. We introduce NeuroOmega system to conduct the designed aDBS experiment for its multifunction and safety. Our group has established collaboration with Department of Eelectronic Engineering in Chang Gung University (Co-PI HL Chan) and BERTEC in National Ciao Tung University (Co-PI MD Ker). Three postdoctor fellows and one senior engineer have been working on the operation of this aDBS system. All hardware and software problems could be sorted out in time. |
| Measure | Description | Time Frame |
|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) | The total motor score of UPDRS (UPDRS III) will be assessed. The subscore of UPDRS item 14 (FoG score) will be test. | 1 year |
| Questionnaire of FoG (FoG-Q) | FoG is difficult to measure due to its unpredictable occurrence. FoG-Q was validated in a large, prospective interventional study for the assessment of FoG severity in PD. In addition, it was found to be a reliable tool for assessment of treatment intervention. | 1 year |
| Quantitative evaluation of FoG | Patients will be asked to walk at their preferred speed along a path 10 m long for 5 times. A triaxial accelerometer (ACC) (TMSI) will be fixed with tape over spinous processes at the upper thoracic level to record trunk acceleration. The episode of FoG will be recorded by both video and the results of Acc signals. | 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Recruiting | Taoyuan | Guishan District | 333 | Taiwan |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |