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Chronic Effects of DBS in Parkinson's Disease and Dystonia (Activa PC+S)

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ClinicalTrials.gov Identifier: NCT01934296
Recruitment Status : Active, not recruiting
First Posted : September 4, 2013
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Philip Starr, University of California, San Francisco

Study Description
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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 movement disorders and how they relate to DBS, not to bring new devices to market.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Isolated Dystonia Device: Activa PC+S Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Chronic Effects of Deep Brain Stimulation on Cortical Local Field Potentials in Parkinson's Disease and Dystonia
Study Start Date : November 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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Arms and Interventions
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Arm Intervention/treatment
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.
 Device: Activa PC+S
Surgical implantation of Activa PC+S as one component of a therapeutic DBS system implantation


Outcome Measures
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Primary Outcome Measures :
  1. Cortical and sub-cortical brain signals using Activa PC+S [ Time Frame: 24 months ]
    Establish whether it is possible to record a reliable cortical and subcortical brain signal using Activa PC+S.


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria(both groups):

  • Ability to give informed consent for the study
  • Movement disorder symptoms that are sufficiently severe, in spite of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria

Inclusion criteria (Isolated dystonia):

  • Age 22-75
  • Isolated dystonia that is generalized or segmental, that must affect one or - Stable doses of anti-dystonia medications (such as Artane, Baclofen, or Clonopin) for at least 30 days prior to baseline assessment
  • For patients with craniofacial involvement, prior treatment with botulinum toxin with failure to adequately control dystonia symptoms.

Inclusion criteria (PD):

  • Age 30-75
  • Bilateral disease (Hoehn and Yahr stage 2 or greater)
  • Has been treated with levodopa/carbidopa, and with a dopamine agonist, at the maximal tolerated doses as determined by a movement disorders neurologist
  • Stable doses of antiParkinsonian medications for at least 30 days prior to their baseline assessment
  • Significant disability in the setting of optimal medical management by a movement disorders neurologist. Disability may be due to tremor that is unresponsive to medications, or to motor fluctuations
  • UPDRS-III score off medication between 20 and 60
  • Improvement of at least 30% in the baseline UPDRS-III on medication score, compared to the baseline off-medication score.

Exclusion Criteria (both groups):

  • Pregnancy or breast feeding
  • MRI showing cortical atrophy out of proportion to age
  • MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder,
  • Major comorbidity increasing the risk of surgery (prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin)
  • Inability to comply with study follow-up visits
  • Any prior intracranial surgery
  • Mood depression with a Beck depression inventory score of > 17 on baseline screening
  • Significant cognitive impairment (MoCA<25).
  • History of seizures
  • Immunocompromised
  • Has an active infection
  • Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic - Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01934296


Locations
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United States, California
UCSF Surgical Movement Disorders Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Medtronic
Investigators
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Principal Investigator: Philip Starr, MD University of California, San Francisco
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Philip Starr, Professor, Neurological Surgery, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01934296    
Other Study ID Numbers: Activa PC+S
First Posted: September 4, 2013    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Keywords provided by Philip Starr, University of California, San Francisco:
deep brain stimulation
cortical recording
neuroprosthesis
Additional relevant MeSH terms:
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Parkinson Disease
Dystonia
Dystonic Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms