LFP Beta aDBS Feasibility Study

NCT ID: NCT03446833

Last Updated: 2019-09-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-04
• Study Completion Date: 2019-02-06

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

All Subjects

Subjects who meet the intraoperative criteria will receive The LFP Beta aDBS System.

Group Type: EXPERIMENTAL

The LFP Beta aDBS System

Intervention Type: DEVICE

The LFP Beta aDBS System is intended for use in patients receiving DBS for Parkinson's Disease where LFPs may be recorded and analyzed.

Interventions

The LFP Beta aDBS System

The LFP Beta aDBS System is intended for use in patients receiving DBS for Parkinson's Disease where LFPs may be recorded and analyzed.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Preoperative:

1. Subject has the ability to understand and provide written informed consent for participation in the study prior to the study-related procedures being conducted

2. 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

3. Subject is ≥ 22 years of age at time of informed consent

4. 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

5. 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

6. 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

7. Subject can read and understand English

8. Subject is willing and able to attend all study-required visits and complete the study procedures

9. Subject is willing and able to be awake during left and right DBS lead implant surgery and for intraoperative LFP recordings

Intraoperative:

10. Required beta band (13 - 30 Hz) signal detected on left and right DBS leads

Exclusion Criteria

1. Subject has tremor dominant PD ≥ 2 at rest in head, upper, or lower extremities as measured on the UPDRS Part III Question 20

2. Subject requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)

3. Subject has a history of prior intracranial surgery (eg, DBS, lesioning, previous surgical ablation)

4. Subject is unable to undergo Magnetic Resonance Imaging (MRI) of the head for planning the surgical DBS lead implants

5. 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

6. Subject has a metallic implant in the head, (eg, aneurysm clip, cochlear implant)

7. 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)

8. 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

9. Subject has, or plans to obtain, an implanted electrical stimulation medical device anywhere in the body (eg, cardiac pacemaker, defibrillator, spinal cord stimulator)

10. Subject has, or plans to obtain, an implanted medication pump (eg, DUOPATM infusion pump) and/or portable infusion pump

11. Based on the opinion of the investigator, the subject has an abnormal neurological examination that would preclude them from study participation

12. Subject is breast feeding

13. Subject has Mattis Dementia Rating Scale-2 (DRS-2) score ≤ 130

14. Subject has Beck Depression Inventory II (BDI-II) > 25

15. Subject is currently participating, or plans to participate, in another investigational study unless written approval is provided by the Medtronic study team

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedtronicNeuro

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

aDBS Clinical Research Team

Role: STUDY_DIRECTOR

Medtronic RTG Brain Therapies

Locations

Stanford

Palo Alto, California, United States

UPMC

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

MDT17076

Identifier Type: -

Identifier Source: org_study_id