- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01934296
Chronic Effects of DBS in Parkinson's Disease and Dystonia (Activa PC+S)
April 4, 2023 updated by: Philip Starr, University of California, San Francisco
Chronic Effects of Deep Brain Stimulation on Cortical Local Field Potentials in Parkinson's Disease and Dystonia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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San Francisco, California, United States, 94115
- UCSF Surgical Movement Disorders Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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Surgical implantation of Activa PC+S as one component of a therapeutic DBS system implantation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With Parkinson's Disease With Reliable Cortical and Sub-cortical Brain Signals
Time Frame: 24 months
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To report number of PD patients with reliable cortical and subcortical brain signal recorded using Activa PC+S.
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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Philip Starr, MD, University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
December 1, 2021
Study Completion (Actual)
December 1, 2021
Study Registration Dates
First Submitted
August 29, 2013
First Submitted That Met QC Criteria
August 29, 2013
First Posted (Estimate)
September 4, 2013
Study Record Updates
Last Update Posted (Actual)
April 24, 2023
Last Update Submitted That Met QC Criteria
April 4, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Activa PC+S
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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