LFP Beta aDBS Feasibility Study
Primary Purpose
Parkinson Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The LFP Beta aDBS System
Sponsored by
About this trial
This is an interventional device feasibility trial for Parkinson Disease focused on measuring Parkinson's Disease, Deep Brain Stimulation
Eligibility Criteria
Inclusion Criteria:
Preoperative:
- Subject has the ability to understand and provide written informed consent for participation in the study prior to the study-related procedures being conducted
- Subject with levodopa-responsive PD of at least 4 years' duration, with symptoms not adequately controlled with medication, including individuals with motor complications of recent onset (from 4 months to 3 years) or with motor complications of longer-standing duration, and who are eligible for bilateral STN DBS surgery
- Subject is ≥ 22 years of age at time of informed consent
- Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using, or agree to use, a medically-acceptable method of birth control as confirmed by the investigator
- Subject has documented improvement in motor signs ON versus OFF dopaminergic medication, with a change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III score of > 30% OFF to ON medication
- Based on the opinion of the Neurosurgeon, the subject is an acceptable candidate for implant of a DBS System that includes: bilateral DBS leads targeted to the STN, extensions, and neurostimulator
- Subject can read and understand English
- Subject is willing and able to attend all study-required visits and complete the study procedures
Subject is willing and able to be awake during left and right DBS lead implant surgery and for intraoperative LFP recordings
Intraoperative:
- Required beta band (13 - 30 Hz) signal detected on left and right DBS leads
Exclusion Criteria
- Subject has tremor dominant PD ≥ 2 at rest in head, upper, or lower extremities as measured on the UPDRS Part III Question 20
- Subject requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
- Subject has a history of prior intracranial surgery (eg, DBS, lesioning, previous surgical ablation)
- Subject is unable to undergo Magnetic Resonance Imaging (MRI) of the head for planning the surgical DBS lead implants
- Based on the opinion of the Neurosurgeon, the subject has a clinically significant structural abnormality(ies) of the brain that would jeopardize subject safety during the DBS lead implant, conduct of the study, or confound the subject's assessments
- Subject has a metallic implant in the head, (eg, aneurysm clip, cochlear implant)
- Subject has a major comorbidity increasing the risk of surgery (eg, prior stroke, severe diabetes, severe hypertension, immunocompromised, seizure disorder, active infection, need for chronic anticoagulation other than aspirin)
- Subject has a neurocognitive impairment which exceeds the criteria for PD mild cognitive impairment (PD-MCI) as determined from the center's clinical neuropsychological evaluation prior to DBS for PD
- Subject has, or plans to obtain, an implanted electrical stimulation medical device anywhere in the body (eg, cardiac pacemaker, defibrillator, spinal cord stimulator)
- Subject has, or plans to obtain, an implanted medication pump (eg, DUOPATM infusion pump) and/or portable infusion pump
- Based on the opinion of the investigator, the subject has an abnormal neurological examination that would preclude them from study participation
- Subject is breast feeding
- Subject has Mattis Dementia Rating Scale-2 (DRS-2) score ≤ 130
- Subject has Beck Depression Inventory II (BDI-II) > 25
- Subject is currently participating, or plans to participate, in another investigational study unless written approval is provided by the Medtronic study team
Sites / Locations
- Stanford
- UPMC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All Subjects
Arm Description
Subjects who meet the intraoperative criteria will receive The LFP Beta aDBS System.
Outcomes
Primary Outcome Measures
Operational Performance: Stimulation amplitude and LFP signals
To characterize the stimulation amplitude and LFP signals during execution of the Medtronic LFP -based aDBS adaptive algorithm. Descriptive statistics will be reported across different PD medication states and subject activities.
Secondary Outcome Measures
Acute Clinical Effect: motor examination
The UPDRS III motor exam score will be assessed. Descriptive statistics will be reported.
Acute Clinical Effect: speech
UPDRS III item 18 will be used to score a standardized reading passage. Descriptive statistics will be reported.
Acute Clinical Effect: dyskinesia
UPDRS IV item 33 will be used to assess dyskinesias. Descriptive statistics will be reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03446833
Brief Title
LFP Beta aDBS Feasibility Study
Official Title
Local Field Potential (LFP) Beta Adaptive Deep Brain Stimulation (aDBS) Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Business decision
Study Start Date
September 4, 2018 (Actual)
Primary Completion Date
February 6, 2019 (Actual)
Study Completion Date
February 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedtronicNeuro
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to use local field potentials as control signals for adjusting DBS stimulation settings under varying patient states and to assess patient outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's Disease, 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
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All Subjects
Arm Type
Experimental
Arm Description
Subjects who meet the intraoperative criteria will receive The LFP Beta aDBS System.
Intervention Type
Device
Intervention Name(s)
The LFP Beta aDBS System
Intervention Description
The LFP Beta aDBS System is intended for use in patients receiving DBS for Parkinson's Disease where LFPs may be recorded and analyzed.
Primary Outcome Measure Information:
Title
Operational Performance: Stimulation amplitude and LFP signals
Description
To characterize the stimulation amplitude and LFP signals during execution of the Medtronic LFP -based aDBS adaptive algorithm. Descriptive statistics will be reported across different PD medication states and subject activities.
Time Frame
Approximately 6 months post implant
Secondary Outcome Measure Information:
Title
Acute Clinical Effect: motor examination
Description
The UPDRS III motor exam score will be assessed. Descriptive statistics will be reported.
Time Frame
Approximately 6 months post implant
Title
Acute Clinical Effect: speech
Description
UPDRS III item 18 will be used to score a standardized reading passage. Descriptive statistics will be reported.
Time Frame
Approximately 6 months post implant
Title
Acute Clinical Effect: dyskinesia
Description
UPDRS IV item 33 will be used to assess dyskinesias. Descriptive statistics will be reported.
Time Frame
Approximately 6 months post implant
Other Pre-specified Outcome Measures:
Title
Number of participants with adverse events and device deficiencies
Description
To characterize the number of participants with serious, device-related, therapy related, and/or procedure-related adverse events and all device deficiencies assess from enrollment through study completion, using MedRA coding
Time Frame
Through Study Completion, an average of 4 years
Title
Number of participants with acute stimulation-induced effects
Description
To characterize the number of participants with acute stimulation-induced effects of the Medtronic LFP-based aDBS algorithm assessed during all study visits that the aDBS algorithm is enabled, using MedDRA coding.
Time Frame
Approximately 6 months post implant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Preoperative:
Subject has the ability to understand and provide written informed consent for participation in the study prior to the study-related procedures being conducted
Subject with levodopa-responsive PD of at least 4 years' duration, with symptoms not adequately controlled with medication, including individuals with motor complications of recent onset (from 4 months to 3 years) or with motor complications of longer-standing duration, and who are eligible for bilateral STN DBS surgery
Subject is ≥ 22 years of age at time of informed consent
Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using, or agree to use, a medically-acceptable method of birth control as confirmed by the investigator
Subject has documented improvement in motor signs ON versus OFF dopaminergic medication, with a change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III score of > 30% OFF to ON medication
Based on the opinion of the Neurosurgeon, the subject is an acceptable candidate for implant of a DBS System that includes: bilateral DBS leads targeted to the STN, extensions, and neurostimulator
Subject can read and understand English
Subject is willing and able to attend all study-required visits and complete the study procedures
Subject is willing and able to be awake during left and right DBS lead implant surgery and for intraoperative LFP recordings
Intraoperative:
Required beta band (13 - 30 Hz) signal detected on left and right DBS leads
Exclusion Criteria
Subject has tremor dominant PD ≥ 2 at rest in head, upper, or lower extremities as measured on the UPDRS Part III Question 20
Subject requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
Subject has a history of prior intracranial surgery (eg, DBS, lesioning, previous surgical ablation)
Subject is unable to undergo Magnetic Resonance Imaging (MRI) of the head for planning the surgical DBS lead implants
Based on the opinion of the Neurosurgeon, the subject has a clinically significant structural abnormality(ies) of the brain that would jeopardize subject safety during the DBS lead implant, conduct of the study, or confound the subject's assessments
Subject has a metallic implant in the head, (eg, aneurysm clip, cochlear implant)
Subject has a major comorbidity increasing the risk of surgery (eg, prior stroke, severe diabetes, severe hypertension, immunocompromised, seizure disorder, active infection, need for chronic anticoagulation other than aspirin)
Subject has a neurocognitive impairment which exceeds the criteria for PD mild cognitive impairment (PD-MCI) as determined from the center's clinical neuropsychological evaluation prior to DBS for PD
Subject has, or plans to obtain, an implanted electrical stimulation medical device anywhere in the body (eg, cardiac pacemaker, defibrillator, spinal cord stimulator)
Subject has, or plans to obtain, an implanted medication pump (eg, DUOPATM infusion pump) and/or portable infusion pump
Based on the opinion of the investigator, the subject has an abnormal neurological examination that would preclude them from study participation
Subject is breast feeding
Subject has Mattis Dementia Rating Scale-2 (DRS-2) score ≤ 130
Subject has Beck Depression Inventory II (BDI-II) > 25
Subject is currently participating, or plans to participate, in another investigational study unless written approval is provided by the Medtronic study team
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
aDBS Clinical Research Team
Organizational Affiliation
Medtronic RTG Brain Therapies
Official's Role
Study Director
Facility Information:
Facility Name
Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
12. IPD Sharing Statement
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LFP Beta aDBS Feasibility Study
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