LFP Beta aDBS Feasibility Study

Medtronic

Status

Terminated

Conditions

Parkinson Disease

Treatments

Device: The LFP Beta aDBS System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03446833

MDT17076

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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