LFP Correlates of Movement Disorders
LFP Correlates of Movement Disorders
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.
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.
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.