Selectively Modulating Pathophysiological Biomaker to Improve Freezing of Gait in Parkinson' s Disease by Adaptive Subthalamic Stimulation
Primary Purpose
Freezing of Gait, Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Neuro Omega
Sponsored by
About this trial
This is an interventional treatment trial for Freezing of Gait
Eligibility Criteria
Inclusion Criteria:
- Patients' age between 20 and 75 years old
- Idiopathic PD with cardinal motor impairment (bradykinesia, rigidity, tremor and postural instability
- Advanced PD as determined by Hoehn and Yahr stage or UPDRS part III motor score
- Levodopa responsive
- Disabling Parkinson's symptoms or drug side effects (dyskinesia, motor fluctuation or disabling "off"period) despite the best medical therapy.
- Willingness and ability to cooperate during conscious operative and experimental procedure.
- Normal MRI
Exclusion Criteria:
- Non-idiopathic parkinsonism or "Parkinson's plus syndrome"
- Impaired cognitive dysfunction (MMSE<26)
- Moderate to severe depression (BDI≧30)
- Depression (BDI≧30), or psychiatric disorder
- Structure lesion such as stroke, tumor or severe brain atrophy revealed by MRI
- Major medical disorders, such as hematological, heart disease or malignancy
- Significant medical, surgical or neurological co-morbidities contraindicating DBS surgery or stimulation
Sites / Locations
- Chang Gung Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PD patient who have FoG
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04197947
First Posted
December 10, 2019
Last Updated
December 11, 2019
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04197947
Brief Title
Selectively Modulating Pathophysiological Biomaker to Improve Freezing of Gait in Parkinson' s Disease by Adaptive Subthalamic Stimulation
Official Title
Selectively Modulating Pathophysiological Biomaker to Improve Freezing of Gait in Parkinson' s Disease by Adaptive Subthalamic Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2019 (Actual)
Primary Completion Date
January 23, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Freezing of Gait, Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PD patient who have FoG
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Neuro Omega
Intervention Description
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.
Primary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale (UPDRS)
Description
The total motor score of UPDRS (UPDRS III) will be assessed. The subscore of UPDRS item 14 (FoG score) will be test.
Time Frame
1 year
Title
Questionnaire of FoG (FoG-Q)
Description
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.
Time Frame
1 year
Title
Quantitative evaluation of FoG
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients' age between 20 and 75 years old
Idiopathic PD with cardinal motor impairment (bradykinesia, rigidity, tremor and postural instability
Advanced PD as determined by Hoehn and Yahr stage or UPDRS part III motor score
Levodopa responsive
Disabling Parkinson's symptoms or drug side effects (dyskinesia, motor fluctuation or disabling "off"period) despite the best medical therapy.
Willingness and ability to cooperate during conscious operative and experimental procedure.
Normal MRI
Exclusion Criteria:
Non-idiopathic parkinsonism or "Parkinson's plus syndrome"
Impaired cognitive dysfunction (MMSE<26)
Moderate to severe depression (BDI≧30)
Depression (BDI≧30), or psychiatric disorder
Structure lesion such as stroke, tumor or severe brain atrophy revealed by MRI
Major medical disorders, such as hematological, heart disease or malignancy
Significant medical, surgical or neurological co-morbidities contraindicating DBS surgery or stimulation
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
State/Province
Guishan District
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chiung-Chu Chen, MD, PhD
Phone
886-3-3281200
Ext
5236
Email
zoe@cgmh.org.tw
12. IPD Sharing Statement
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Selectively Modulating Pathophysiological Biomaker to Improve Freezing of Gait in Parkinson' s Disease by Adaptive Subthalamic Stimulation
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