Characterizing the Specificity and Stability of Local Field Potentials in the Globus Pallidus Internus of Patients Undergoing Deep Brain Stimulation for Parkinson's Disease

NCT02438033 | Withdrawn Phase 1 DMC

• 1 other identifier: PC PC+S
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Deep brain stimulation for Parkinson's disease is a well established therapy. Current practice requires tedious adjustment of stimulation settings based on frequent patient assessments. Ultimately, the goal is to develop a system that can program itself using signals that are recorded directly from the brain on a continuous basis. Our previous work has identified abnormal electrical signals in the brain that are targeted for stimulation that can potentially be used to develop a self-programming system. In this study, the investigators will test the safety and utility of a novel adapted device that can not only deliver stimulation to the brain but also record brain signals in a patient that is implanted with a deep brain stimulation system. The purpose of this Phase I study is to understand the safety of the device as well as the relationship between these electrical signals measured from deep within the brain and Parkinson's symptoms and how these signals can be used to guide a self-programmed system. The study will entail implanting this special device (Activa PC+S) in place of the standard generator (Activa PC) and to compare clinical symptoms, recorded brain signals, and stimulation patterns during a one year period after implantation. Specifically, the investigators will use the Activa PC+S to record GPi (internal globus pallidus) local field potentials between and during programming visits, allowing the surgeon to better characterize a patient's disease. At the same time, the investigators will evaluate the safety of this new device.

Conditions

Parkinson's Disease

Keywords

Deep Brain Stimulation; Globus Pallidus; GPi; PC+S

Outcome Measures

Primary Outcomes (1)

• Change in Unified Parkinson's Disease Rating Scale (UPDRS)

  12 months

Secondary Outcomes (2)

• Change in Hoehn and Yahr Scale

  12 months

• Change in Parkinson's Disease Questionnaire (PDQ-39)

  12 months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

All patients will be implanted with the investigational device in an open-label fashion

Device: Medtronic Activa PC+S Sensing Deep Brain Stimulator Generator

Interventions

Medtronic Activa PC+S Sensing Deep Brain Stimulator Generator DEVICE

Patients undergoing deep brain stimulation for Parkinson's disease based on clinically indicated criteria will have the option to enroll in this study, in which the Activa PC+S generator and corresponding extension leads will be implanted rather than the standard Activa PC system. Patients will be assessed every month for 3 months and then every 3 months after, including off and on medication assessments.

Treatment Arm

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chart diagnosis of PD as the principal neurologic diagnosis with evidence of dopamine responsiveness.
• Documented PD duration \> 5 years.
• Clinical indications for GPi DBS based on presence of motor fluctuations with troublesome dyskinesias despite best medical therapy.
• Age ≥ 21 years of age.
• Able to give informed consent in accordance with institutional policies and participate in the 1-year follow-up, involving assessments and stimulator adjustments.
• Willingness to have unexpected neurological or psychiatric symptoms shared with study clinicians.
• Other medical conditions must be stable for at least 1 year, (conditions that require intermittent use of steroids or chemotherapy are excluded).

You may not qualify if:

• Tremor-dominant PD.
• Significant neurocognitive impairment in memory domain suggestive of dementing process (based on MOCA and PD-CRS, described below).
• Age \> 75 years.
• History of implant-related infection.
• History of bleeding or immune-compromise.
• Patient living greater than 100 miles from UCLA.
• Suicide attempt in the last two years and/or presence of a suicide plan (an answer of "Yes" to Question C4 in Section C-Suicidality of MINI International Neuropsychiatric Interview).
• Alcohol or illicit substance use disorder within the last 6 months, unstable remission of substance abuse, or chart evidence that co-morbid substance use disorder could account for lack of treatment response.
• Current significant neurological conditions, including epilepsy, stroke, or history of serious head injury with loss of consciousness.
• Uncontrolled medical condition including cardiovascular problems and diabetes.
• Pregnant or planning to become pregnant
• Uncontrolled chronic pain.
• Preoperative use of warfarin or any blood thinning or antiplatelet agent or any patient with abnormally elevated preoperative coagulation profile (either PTT or PT/INR)..
• Significant abnormality on preoperative structural brain MRI.
• Contraindications to MRIs or the need for recurrent body MRIs.

Sponsors & Collaborators

• Nader Pouratian: lead
• Medtronic: collaborator

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Nader Pouratian, MD PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asst Professor of Neurosurgery

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 8, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2017
• Last Updated: February 25, 2016

Record last verified: 2016-02