LFP Beta aDBS Feasibility Study

Parkinson Disease Clinical Trial

Official title:

Local Field Potential (LFP) Beta Adaptive Deep Brain Stimulation (aDBS) Feasibility Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03446833
• Other study ID #: MDT17076
• Status: Terminated
• Phase: N/A
• Start date: September 4, 2018
• Est. completion date: February 6, 2019

Study information

• Verified date: September 2019
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 6, 2019
• Est. primary completion date: February 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Stanford	Palo Alto	California
United States	UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with adverse events and device deficiencies	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	Through Study Completion, an average of 4 years
Other	Number of participants with acute stimulation-induced effects	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.	Approximately 6 months post implant
Primary	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.	Approximately 6 months post implant
Secondary	Acute Clinical Effect: motor examination	The UPDRS III motor exam score will be assessed. Descriptive statistics will be reported.	Approximately 6 months post implant
Secondary	Acute Clinical Effect: speech	UPDRS III item 18 will be used to score a standardized reading passage. Descriptive statistics will be reported.	Approximately 6 months post implant
Secondary	Acute Clinical Effect: dyskinesia	UPDRS IV item 33 will be used to assess dyskinesias. Descriptive statistics will be reported.	Approximately 6 months post implant