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Completed

NCT Number: NCT02709148

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

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.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of idiopathic Parkinson's Disease (PD).
  • Age 45-75 years
  • UPDRS III motor score (off PD medications) ≥ 25
  • Demonstrated good response (≥ 30%) to Sinemet or dopamine agonist medications as assessed by total UPDRS III score (off and on meds)
  • 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
  • Cleared to be scanned in a 7 tesla magnet
  • Written documentation of willingness to participate in the study per protocol as evidenced by the informed consent process

Exclusion criteria

  • Clinically significant medical disease that would increase the risk of developing pre- or post-operative complications (e.g., significant cardiac or pulmonary disease)
  • Evidence of secondary or atypical parkinsonism
  • Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain.
  • Unable to undergo magnetic resonance imaging (e.g., due to incompatible implanted pacemaker)
  • Previous pallidotomy or DBS surgery
  • Women who are currently pregnant or are breast feeding
  • MRI showing cortical atrophy out of proportion to age and/or MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder
  • Any prior intracranial surgery
  • Subjects with depression defined according to Diagnostic and Statistical Manual V criteria and a scored on a validated depression assessment scale
  • History of seizures
  • Immunocompromised
  • Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition
  • Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.

Treatment and study plan

Activa PC+S

Device

DBS

Primary outcomes

  1. Cortical and sub-cortical brain signals using Activa PC+S

    Time frame: 12 months

    Establish whether it is possible to record a reliable cortical and subcortical brain signal using Activa PC+S.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 15, 2016
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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