State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With Deep Brain Stimulation (DBS)

NCT ID: NCT02709148

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-20
• Study Completion Date: 2020-07-31

Brief Summary

The purpose of this study is to use an investigational device to record brain activity for 12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The goal of the study is better understanding of brain activity in Parkinson's disease and how they relate to DBS and pharmacological management, not to bring new devices to market.

Detailed Description

Experimental: chronic brain recording This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments.

Conditions

Parkinson's Disease

Study Design

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

Study Groups

chronic brain recording

This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments.

Group Type: EXPERIMENTAL

Activa PC+S

Intervention Type: DEVICE

DBS

Interventions

Activa PC+S

DBS

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of idiopathic Parkinson's Disease (PD).

2. Age 45-75 years

3. UPDRS III motor score (off PD medications) ≥ 25

4. Demonstrated good response (≥ 30%) to Sinemet or dopamine agonist medications as assessed by total UPDRS III score (off and on meds)

5. Approved for unilateral subthalamic nucleus (STN)- or globus pallidus internus (GPi)-DBS surgery to treat their clinical motor signs and plan to undergo the standard of care procedure within the next four months

6. Cleared to be scanned in a 7 tesla magnet

7. Written documentation of willingness to participate in the study per protocol as evidenced by the informed consent process

Exclusion Criteria

1. Clinically significant medical disease that would increase the risk of developing pre- or post-operative complications (e.g., significant cardiac or pulmonary disease)

2. Evidence of secondary or atypical parkinsonism

3. Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain.

4. Unable to undergo magnetic resonance imaging (e.g., due to incompatible implanted pacemaker)

5. Previous pallidotomy or DBS surgery

6. Women who are currently pregnant or are breast feeding

7. MRI showing cortical atrophy out of proportion to age and/or MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder

8. Any prior intracranial surgery

9. Subjects with depression defined according to Diagnostic and Statistical Manual V criteria and a scored on a validated depression assessment scale

10. History of seizures

11. Immunocompromised

12. Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition

13. Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerrold Vitek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

NEURO-2016-24512

Identifier Type: -

Identifier Source: org_study_id