LFP Beta aDBS Feasibility Study

Not Applicable

Terminated

• Conditions: Parkinson Disease
• Interventions: Device: The LFP Beta aDBS System

• Registration Number: NCT03446833
• Lead Sponsor: MedtronicNeuro

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-02-23
• Study First Posted: 2018-02-27
• Study Start: 2018-09-04
• Primary Completion: 2019-02-06
• Study Completion: 2019-02-06
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Subjects	The LFP Beta aDBS System	Subjects who meet the intraoperative criteria will receive The LFP Beta aDBS System.

Primary Outcome Measures

Name	Time	Method
Operational Performance: Stimulation amplitude and LFP signals	Approximately 6 months post implant	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

Name	Time	Method
Acute Clinical Effect: speech	Approximately 6 months post implant	UPDRS III item 18 will be used to score a standardized reading passage. Descriptive statistics will be reported.
Acute Clinical Effect: dyskinesia	Approximately 6 months post implant	UPDRS IV item 33 will be used to assess dyskinesias. Descriptive statistics will be reported.
Acute Clinical Effect: motor examination	Approximately 6 months post implant	The UPDRS III motor exam score will be assessed. Descriptive statistics will be reported.

Trial Locations

Locations (2)

Stanford; 🇺🇸 Palo Alto, California, United States

UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States