- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02115802
LFP Correlates of Movement Disorders
February 21, 2016 updated by: Adam O Hebb, Colorado Neurological Institute
Local Field Potential Correlates of Motor Behavior and Pathological Signs in Movement Disorders for Development of Closed Loop Stimulation Systems
The purpose of this study is to record electrical brain activity during DBS surgery and after DBS surgery using the Medtronic Activa PC+S deep brain stimulation (DBS) system, a modified DBS pulse generator.
The goal of the study is to investigate if the electrical brain activity can help customize DBS therapy.
Study Overview
Detailed Description
The Activa PC+S system will be implanted and programmed under the same clinical procedures and standard of care as the Activa PC system.
After implantation and standard clinical programming, participants in our research study will be asked to return for additional research visits where the recording sub-circuit of the device will be activated and local field potentials (LFP) will be recorded in the device and transmitted through telemetry to a base station for storage and future analysis.
The sensing, or recording, sub-circuit will be disabled, non-invasively, at the end of each research visit to minimize impact to battery life of the device.
Study Type
Interventional
Enrollment (Anticipated)
10
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 Contact
- Name: Sara Hanrahan, PhD
- Phone Number: 720-974-4093
- Email: shanrahan@thecni.org
Study Locations
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Colorado
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Englewood, Colorado, United States, 80113
- Recruiting
- Colorado Neurological Institute
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Principal Investigator:
- Adam O Hebb, MD
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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
21 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Potential participants must be undergoing DBS lead placement for Parkinson's Disease that requires them to be awake during microelectrode recording.
- Potential participants have been treated with levodopa/carbidopa, and with a dopamine agonist, at the maximal tolerated doses as determined by a movement disorders neurologist.
- Potential participants must have a Hoehn and Yahr stage >= 2 in the medications OFF state.
- Potential participants must have documented improvement in motor signs on versus off dopaminergic medication, with a change in the Unified Parkinson's Disease Rating Scale motor (UPDRS III) score of >= 30% off to on medication. Patients with tremor predominant form of PD, quantified as a UPDRS tremor score in any one limb greater than or equal to 3 and UPDRS sum of axial score (speech, posture, gait, balance) less than or equal to 5, who do not reach the 30% threshold, may be included.
- Potential participants must have evidence of complications of medication, e.g., wearing off signs, fluctuating responses and/or dyskinesias, and/or medication refractory tremor, and/or impairment in the quality of life on or off medication.
- Potential participants must have the ability to understand instructions in English.
- Potential participants are males or females between the ages of 21 and 75.
Exclusion Criteria:
- Individuals who are pregnant, breastfeeding, or are capable of becoming pregnant and not using an acceptable method of birth control. Acceptable methods of birth control include hormonal contraceptives, intrauterine device, abstinence or spermicide and barrier.
- Individuals who have magnetic resonance imaging (MRI) scans demonstrating cortical atrophy out of proportion to age.
- Individuals who have MRI scans showing focal brain lesions that could indicate a nonidiopathic movement disorder.
- Individuals who have major comorbidity increasing the risk of surgery such as prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin.
- Individuals who have had any prior intracranial surgery.
- Individuals who have clinically active depression defined according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria and scored on a validated depression assessment scale.
- Individuals who have significant cognitive impairment and/or dementia as determined by a standardized neuropsychological battery.
- Individuals who have a history of seizures.
- Individuals who are immunocompromised.
- Individuals who have an active infection.
- Individuals who require diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition.
- Individuals who have an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.
- Individuals who, at the discretion of the research team member, lack the cognitive ability to understand the instructions and fully participate in research tasks.
- Unable to understand written and spoken instructions in English. Individuals who carry a concomitant diagnosis that would preclude them from fully participating in the research tasks due to difficulties associated with comprehending instructions, cooperating with research tasks, or otherwise rendering the individuals incapable of participating in the research tasks. Examples could include a visual or hearing impairment preventing the individual from viewing a computer screen or hearing instructions.
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: Activa PC+S
Specific features of LFP recorded from the deep brain nuclei will be examined for possible correlation with different natural behaviors, such as movement, walking, or speech.
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Subjects will undergo placement of bilateral standard Deep Brain Stimulation (DBS) electrodes (Medtronic model 3387/3389) and implantation of the Activa PC+S, a modified impulse generator (IPG) for DBS with the added technology of neural signal recording.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Specific features of local field potentials recorded from the deep brain nuclei during different natural behaviors, such as movement, walking, or speech.
Time Frame: 3 years
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The broadband time domain neural signal across all bipolar pairs will be recorded in series while subjects perform structured behavioral tasks.
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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adam O Hebb, MD, Colorado Neurological Institute
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
May 1, 2014
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
April 14, 2014
First Submitted That Met QC Criteria
April 14, 2014
First Posted (Estimate)
April 16, 2014
Study Record Updates
Last Update Posted (Estimate)
February 23, 2016
Last Update Submitted That Met QC Criteria
February 21, 2016
Last Verified
February 1, 2016
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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