Back to resultsDBS Recordings to Characterize Movement Facilitation in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Movement task
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson Disease focused on measuring deep brain stimulation, neuromodulation, external cueing, movement
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of idiopathic Parkinson's disease based on presence of at least 2 cardinal PD features (tremor, rigidity, or bradykinesia)
- Undergoing deep brain stimulation surgery for treatment of advanced Parkinson's disease, according to clinical evaluation, including the following criteria:
- advanced idiopathic PD as determined by OFF unified Parkinson's Disease Rating Scale (UPDRS) part III motor subscale > 25
- L-dopa responsive symptoms with at least 30% improvement in UPDRS III scores on vs. off medication OR medication refractory disabling tremor
- Persistent disabling motor symptoms or drug side effects (dyskinesias, motor fluctuations, disabling "off" periods) despite optimal medical therapy
- preoperative MRI without evidence of cortical or subdural adhesions or vascular abnormalities
- Willingness and ability to cooperate during conscious operative procedure for up to 40 minutes
Exclusion Criteria:
- medical contraindication to surgery, including use of anticoagulant or antiplatelet therapy within 1 week
- significant cognitive or psychiatric disease based on clinical neuropsychological testing
Sites / Locations
- University of California Los AngelesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Parkinson disease patients
Arm Description
Parkinson disease patients undergoing DBS Surgery of the Globus Pallidus Internus (GPi) for clinical indications
Outcomes
Primary Outcome Measures
Globus pallidus internus local field potentials
power in the beta band
Frontal and parietal electrocorticography
power in the beta band
Secondary Outcome Measures
Full Information
NCT ID
NCT05166655
First Posted
December 16, 2021
Last Updated
September 21, 2023
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT05166655
Brief Title
DBS Recordings to Characterize Movement Facilitation in Parkinson's Disease
Official Title
Intra-operative Recordings to Characterize Movement Facilitation in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Several strategies or contexts help patients with Parkinson's disease to move more quickly or normally, however the brain mechanisms underlying these phenomena are poorly understood. The proposed studies use intraoperative recordings during DBS surgery for Parkinson's disease to understand the brain mechanisms supporting improved movements elicited by external cues. The central hypothesis is that distinct networks are involved in movement improvement depending on characteristics of the facilitating stimulus. Participants will perform movement tasks during awake surgery performed exclusively for clinical indications. The identified biomarkers may provide targets for future neuromodulation therapies to improve symptoms that are refractory to current treatments, such as freezing of gait.
Detailed Description
Patients with Parkinson's disease (PD) will perform computer tasks involving reaching and tapping movements during video recording of movements and electrophysiological recording of brain signals during deep brain stimulation surgery. Experimental manipulations involve different computer stimuli that manipulate the presence or absence of sensory and motivational movement cues. The same experimental manipulations are delivered to all individual subjects. 40 PD patients who are undergoing deep brain stimulation (DBS) surgery for treatment of Parkinson's disease, will perform the tasks during awake surgery and recordings will be obtained from 2 implanted DBS electrodes as well as 2 temporary electrode strips placed on the surface of the brain for research purposes. Study procedures are limited to the intraoperative environment with no additional study visits. All patients will also be asked to perform clinical rating scales and questionnaires and undergo a movement disorders neurological exam.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
deep brain stimulation, neuromodulation, external cueing, movement
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Parkinson disease patients
Arm Type
Experimental
Arm Description
Parkinson disease patients undergoing DBS Surgery of the Globus Pallidus Internus (GPi) for clinical indications
Intervention Type
Behavioral
Intervention Name(s)
Movement task
Intervention Description
Computer task with experimental conditions manipulating sensory and motivation cues for movement.
Primary Outcome Measure Information:
Title
Globus pallidus internus local field potentials
Description
power in the beta band
Time Frame
baseline
Title
Frontal and parietal electrocorticography
Description
power in the beta band
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosis of idiopathic Parkinson's disease based on presence of at least 2 cardinal PD features (tremor, rigidity, or bradykinesia)
Undergoing deep brain stimulation surgery for treatment of advanced Parkinson's disease, according to clinical evaluation, including the following criteria:
advanced idiopathic PD as determined by OFF unified Parkinson's Disease Rating Scale (UPDRS) part III motor subscale > 25
L-dopa responsive symptoms with at least 30% improvement in UPDRS III scores on vs. off medication OR medication refractory disabling tremor
Persistent disabling motor symptoms or drug side effects (dyskinesias, motor fluctuations, disabling "off" periods) despite optimal medical therapy
preoperative MRI without evidence of cortical or subdural adhesions or vascular abnormalities
Willingness and ability to cooperate during conscious operative procedure for up to 40 minutes
Exclusion Criteria:
medical contraindication to surgery, including use of anticoagulant or antiplatelet therapy within 1 week
significant cognitive or psychiatric disease based on clinical neuropsychological testing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katy Cross, MD, PhD
Phone
310-206-2828
Email
kcross@Mednet.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ipek Talu, BA
Phone
310-206-2828
Email
italu@mednet.ucla.edu
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katy Cross, MD, PhD
Phone
210-206-2828
Email
kcross@mednet.ucla.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Electrophysiological and behavioral data obtained during task performance will be made available upon request to Dr. Cross (PI) via secured server access. Data sharing agreement will be required for all requests.
Learn more about this trial
DBS Recordings to Characterize Movement Facilitation in Parkinson's Disease
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