Back to resultsA Responsive Closed-Loop Approach to Treat Freezing of Gait in Parkinson's Disease
Primary Purpose
Parkinsons Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
About this trial
This is an interventional device feasibility trial for Parkinsons Disease focused on measuring Deep Brain Stimulation
Eligibility Criteria
Inclusion Criteria:
- A clinical diagnosis of idiopathic PD, without a previous DBS operation
- Must be deemed appropriate for a GPi DBS operation by the interdisciplinary screening team (GPi must be the target chosen as most appropriate for treatment of their PD to qualify for this study)
- Age 30-75 years (must meet UK Brain Bank criteria for diagnosis of idiopathic Parkinson's disease).
- Experiencing significant gait and postural instability despite optimal pharmacologic management (Hoehn and Yahr Stage II or greater in the on state). 5. Best medication "on" does not reveal meaningful improvement in posture scores (Pull Test). Patients must be challenged in person with a suprathreshold dose of levodopa (1.5 times optimized regular dose of levodopa) and must have poor or no improvement in postural stability.
6. Patients must possess a clinical history of gait freezing > 2 episodes per month, to be included, participants must also score > 1 on item #3 of the Freezing of Gait (FOG) Questionnaire and exhibit five or more FoG episodes during the provocation protocol in on or off state.
7. L-dopa responsive with clearly defined "on" periods. 8. Willingness and ability to cooperate during conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications and stimulator settings.
Exclusion Criteria:
- Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications. Clinically significant medical disease includes uncontrolled systemic hypertension with values above 170/100mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation which cannot be interrupted; any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician.
- Evidence of secondary or atypical parkinsonism.
- Other neurological and musculoskeletal impairments that would negatively influence postural stability
- Past MRI scan with significant evidence of brain atrophy or other abnormalities. 5. Dementia as evidenced by impairment in two neuropsychological domains and a Mattis Dementia Score <130.
6. A major untreated psychiatric disorder as revealed on psychiatric exam at screening, and a Beck Depression Inventory Score >14.
7. Subjects with a history of seizures. 8. Subjects who may require repeat MRI scans. 9. Subjects with a history of a cranial neurosurgical procedure. 10. Subjects with metal in the head or another implanted stimulator (e.g. vagus nerve stimulator, spinal cord stimulator, pacemaker, cochlear implant, etc).
11. Subjects who require treatment with Electroconvulsive therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS).
12. Pregnant or nursing women or women who wish to become pregnant will be excluded.
Sites / Locations
- University of Florida Center for Movement Disorders and Neurorestoration
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Deep Brain Stimulation
Arm Description
Deep Brain Stimulation (DBS) of Globus Pallidum plus Pedunculopontine Nucleus, including lead implant and battery placement. Magnetic Resonance Imaging and Computed Tomography (CT) scan will be obtained prior to implant. Measurement of number of Freezing of Gait (FoG) episodes during a FoG test at a lab. Other measures include freezing of gait questionnaire, gait and falls questionnaire, activities/balance confidence scale, Parkinson's disease quality of life questionnaire, Unified Parkinson's Disease Rating Scale physiology collection and sensor testing, adverse event recording, falls diaries, tracking use of assistive devices, gait and balance testing, and neuropsychological, neurosurgical, neurological, and physical exams.
Outcomes
Primary Outcome Measures
Number of Freezing of Gait (FoG) episodes in the laboratory during the FoG battery
Secondary Outcome Measures
Number of adverse events (AE's) .
The DSMB will review all adverse events (AE's) in real time. The device related AE definition will include both therapy and procedure related AE's. The Data Safety Monitoring Board (DSMB) will evaluate the study at least every 6 months and have the power to terminate the study for safety reasons.
Full Information
NCT ID
NCT02318927
First Posted
December 12, 2014
Last Updated
September 26, 2018
Sponsor
University of Florida
Collaborators
Medtronic, Michael J. Fox Foundation for Parkinson's Research
1. Study Identification
Unique Protocol Identification Number
NCT02318927
Brief Title
A Responsive Closed-Loop Approach to Treat Freezing of Gait in Parkinson's Disease
Official Title
A Responsive Closed-Loop Approach to Treat Freezing of Gait in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
November 3, 2016 (Actual)
Study Completion Date
September 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Medtronic, Michael J. Fox Foundation for Parkinson's Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study objective is to explore Deep Brain Stimulation (DBS) in two specific brain regions (Globus Pallidum, or GPI, plus the pedunculopontine nucleus, or PPN) for on medication freezing of gait (FoG) in Parkinsons Disease (PD). Hopefully, information gathered from these two brain regions after surgery will allow for the development of a personalized DBS system to address FoG. The primary outcome will be a comparison of the pre-operative number of FoG episodes in the laboratory during the FoG battery versus those 6 months post-DBS at the optimized device settings.
Detailed Description
As a participant in the study you will have the following procedure performed:
A series of questions by interview, questionnaires, and checklists will be collected. In addition, basic information (such as age, sex, race) and psychiatric, medical, and family history, physical and neurological exam that will include measuring vital signs (heart rate and blood pressure). There will be a "Falls Diary' to complete (an account of falling incidents and the details). Specific testing will be done to evaluate the gait and balance which will be repeated throughout the study. A psychiatric evaluation of mood and emotion will be performed including a detailed psychological testing, consisting of perception, learning, and memory. These psychological assessments will be repeated at every study visit. An MRI and a CT scan will be performed to make sure of the exact location of the DBS implant. The study will end in 24 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinsons Disease
Keywords
Deep Brain Stimulation
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Deep Brain Stimulation
Arm Type
Experimental
Arm Description
Deep Brain Stimulation (DBS) of Globus Pallidum plus Pedunculopontine Nucleus, including lead implant and battery placement. Magnetic Resonance Imaging and Computed Tomography (CT) scan will be obtained prior to implant. Measurement of number of Freezing of Gait (FoG) episodes during a FoG test at a lab. Other measures include freezing of gait questionnaire, gait and falls questionnaire, activities/balance confidence scale, Parkinson's disease quality of life questionnaire, Unified Parkinson's Disease Rating Scale physiology collection and sensor testing, adverse event recording, falls diaries, tracking use of assistive devices, gait and balance testing, and neuropsychological, neurosurgical, neurological, and physical exams.
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation
Intervention Description
Deep Brain Stimulation (DBS) of Globus Pallidum plus Pedunculopontine Nucleus, including lead implant and battery placement. Magnetic Resonance Imaging and Computed Tomography (CT) scan will be obtained prior to implant. Measurement of number of Freezing of Gait (FoG) episodes during a FoG test at a lab. Other measures include freezing of gait questionnaire, gait and falls questionnaire, activities/balance confidence scale, Parkinson's disease quality of life questionnaire, Unified Parkinson's Disease Rating Scale physiology collection and sensor testing, adverse event recording, falls diaries, tracking use of assistive devices, gait and balance testing, and neuropsychological, neurosurgical, neurological, and physical exams.
Primary Outcome Measure Information:
Title
Number of Freezing of Gait (FoG) episodes in the laboratory during the FoG battery
Time Frame
Change from Baseline to 6 Months
Secondary Outcome Measure Information:
Title
Number of adverse events (AE's) .
Description
The DSMB will review all adverse events (AE's) in real time. The device related AE definition will include both therapy and procedure related AE's. The Data Safety Monitoring Board (DSMB) will evaluate the study at least every 6 months and have the power to terminate the study for safety reasons.
Time Frame
Change from Baseline to 24 Months
Other Pre-specified Outcome Measures:
Title
Freezing of gait questionnaire
Time Frame
Change from Baseline to 6 Months
Title
Gait and falls questionnaire
Time Frame
Change from Baseline to 6 Months
Title
Activities/balance confidence scale
Time Frame
Change from Baseline to 6 Months
Title
Parkinson's disease quality of life questionnaire
Time Frame
Change from Baseline to 6 Months
Title
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 to assess Parkinson's disease symptom severity on medication and on stimulation
Time Frame
Change from Screening to 6 Months
Title
Number of falls reported on Falls Diary
Time Frame
Change from Baseline to 6 Months
Title
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 to assess Parkinson's disease symptom severity off medication and on stimulation
Time Frame
Change from Screening to 6 Months
Title
Total Unified Parkinson's Disease Rating Scale (UPDRS) to assess Parkinson's disease symptom severity on medication and on stimulation
Time Frame
Change from Screening to 6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A clinical diagnosis of idiopathic PD, without a previous DBS operation
Must be deemed appropriate for a GPi DBS operation by the interdisciplinary screening team (GPi must be the target chosen as most appropriate for treatment of their PD to qualify for this study)
Age 30-75 years (must meet UK Brain Bank criteria for diagnosis of idiopathic Parkinson's disease).
Experiencing significant gait and postural instability despite optimal pharmacologic management (Hoehn and Yahr Stage II or greater in the on state). 5. Best medication "on" does not reveal meaningful improvement in posture scores (Pull Test). Patients must be challenged in person with a suprathreshold dose of levodopa (1.5 times optimized regular dose of levodopa) and must have poor or no improvement in postural stability.
6. Patients must possess a clinical history of gait freezing > 2 episodes per month, to be included, participants must also score > 1 on item #3 of the Freezing of Gait (FOG) Questionnaire and exhibit five or more FoG episodes during the provocation protocol in on or off state.
7. L-dopa responsive with clearly defined "on" periods. 8. Willingness and ability to cooperate during conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications and stimulator settings.
Exclusion Criteria:
Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications. Clinically significant medical disease includes uncontrolled systemic hypertension with values above 170/100mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation which cannot be interrupted; any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician.
Evidence of secondary or atypical parkinsonism.
Other neurological and musculoskeletal impairments that would negatively influence postural stability
Past MRI scan with significant evidence of brain atrophy or other abnormalities. 5. Dementia as evidenced by impairment in two neuropsychological domains and a Mattis Dementia Score <130.
6. A major untreated psychiatric disorder as revealed on psychiatric exam at screening, and a Beck Depression Inventory Score >14.
7. Subjects with a history of seizures. 8. Subjects who may require repeat MRI scans. 9. Subjects with a history of a cranial neurosurgical procedure. 10. Subjects with metal in the head or another implanted stimulator (e.g. vagus nerve stimulator, spinal cord stimulator, pacemaker, cochlear implant, etc).
11. Subjects who require treatment with Electroconvulsive therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS).
12. Pregnant or nursing women or women who wish to become pregnant will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Okun, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida Center for Movement Disorders and Neurorestoration
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32581744
Citation
Molina R, Hass CJ, Sowalsky K, Schmitt AC, Opri E, Roper JA, Martinez-Ramirez D, Hess CW, Foote KD, Okun MS, Gunduz A. Neurophysiological Correlates of Gait in the Human Basal Ganglia and the PPN Region in Parkinson's Disease. Front Hum Neurosci. 2020 Jun 4;14:194. doi: 10.3389/fnhum.2020.00194. eCollection 2020.
Results Reference
derived
PubMed Identifier
29060496
Citation
Tahafchi P, Molina R, Roper JA, Sowalsky K, Hass CJ, Gunduz A, Okun MS, Judy JW. Freezing-of-Gait detection using temporal, spatial, and physiological features with a support-vector-machine classifier. Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:2867-2870. doi: 10.1109/EMBC.2017.8037455.
Results Reference
derived
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A Responsive Closed-Loop Approach to Treat Freezing of Gait in Parkinson's Disease
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