- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03446833
LFP Beta aDBS Feasibility Study
September 19, 2019 updated by: MedtronicNeuro
Local Field Potential (LFP) Beta Adaptive Deep Brain Stimulation (aDBS) Feasibility Study
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Palo Alto, California, United States, 94304
- Stanford
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15261
- UPMC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DEVICE_FEASIBILITY
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: All Subjects
Subjects who meet the intraoperative criteria will receive The LFP Beta aDBS System.
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The LFP Beta aDBS System is intended for use in patients receiving DBS for Parkinson's Disease where LFPs may be recorded and analyzed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operational Performance: Stimulation amplitude and LFP signals
Time Frame: Approximately 6 months post implant
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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.
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Approximately 6 months post implant
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute Clinical Effect: motor examination
Time Frame: Approximately 6 months post implant
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The UPDRS III motor exam score will be assessed.
Descriptive statistics will be reported.
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Approximately 6 months post implant
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Acute Clinical Effect: speech
Time Frame: Approximately 6 months post implant
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UPDRS III item 18 will be used to score a standardized reading passage.
Descriptive statistics will be reported.
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Approximately 6 months post implant
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Acute Clinical Effect: dyskinesia
Time Frame: Approximately 6 months post implant
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UPDRS IV item 33 will be used to assess dyskinesias.
Descriptive statistics will be reported.
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Approximately 6 months post implant
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with adverse events and device deficiencies
Time Frame: Through Study Completion, an average of 4 years
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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
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Through Study Completion, an average of 4 years
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Number of participants with acute stimulation-induced effects
Time Frame: Approximately 6 months post implant
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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.
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Approximately 6 months post implant
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: aDBS Clinical Research Team, Medtronic RTG Brain Therapies
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 4, 2018
Primary Completion (ACTUAL)
February 6, 2019
Study Completion (ACTUAL)
February 6, 2019
Study Registration Dates
First Submitted
January 22, 2018
First Submitted That Met QC Criteria
February 23, 2018
First Posted (ACTUAL)
February 27, 2018
Study Record Updates
Last Update Posted (ACTUAL)
September 23, 2019
Last Update Submitted That Met QC Criteria
September 19, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDT17076
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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