Effects of Stimulation Patterns of Deep Brain Stimulation
Effects of Stimulation Patterns of Deep Brain Stimulation
The purpose of this study is to measure the effects of non-regular temporal patterns of deep
 brain stimulation (DBS) on motor symptoms and neural activity in persons with Parkinson's
 disease (PD), essential tremor (ET) or multiple sclerosis (MS). These data will guide the
 design of novel stimulation patterns that may lead to more effective and reliable treatment
 with DBS. These data will also enable evaluation of current hypotheses on the mechanisms of
 action of DBS. Improving our understanding of the mechanisms of action of DBS may lead to
 full development of DBS as a treatment for Parkinson's disease and may lead to future
 applications of DBS.
This study will be conducted in the operating rooms at Duke University Medical Center, Emory
 University Hospital, University of Florida Shands Hospital or the UF Health Florida Surgical
 Center. The study will be performed during surgery on subjects who are undergoing
 implantation of the deep brain stimulation (DBS) system during an awake procedure, or on
 subjects who are receiving surgical replacement of the implanted pulse generator (IPG) due to
 depleted batteries.

 Subjects will receive temporary sterile extensions to the DBS electrode. These temporary
 extensions will connect to a stimulation and recording system and allow recording of neural
 activity. Over the course of ~45 minutes different non-regular temporal patterns of
 stimulation will be delivered unilaterally and the effects on neural activity and movement
 disorder symptoms will be measured. The stimulus waveform will be a charge-balanced biphasic
 pulse, with charge restricted to values below the limit set by the DBS IPG manufacturer, 30
 μC/cm². After the study is completed, the temporary extensions will be removed, and the
 ordinary clinical conduct of the procedure will continue for treatment of the patient's
 movement disorder.

 Tremor will be measured using an accelerometer in subjects with essential tremor (ET),
 multiple sclerosis (MS) and tremor-dominant Parkinson's disease (PD). Bradykinesia will be
 measured using a finger-tapping task on a computer mouse in subjects with Parkinson's disease
 who do not have dominant tremor symptoms. Subjects will be familiarized with the motor
 symptom evaluation tasks before surgery, and baseline measurements of tremor or bradykinesia
 may be recorded. Further, they may be asked to discontinue use of anti-parkinsonian and/or
 anti-tremor medications overnight prior to the study, to reduce variability of motor symptoms
 due to the time course of medications.

 No general anesthesia will be given to subjects during surgery, and the procedure will be
 performed under local anesthesia to allow subjects to perform the tasks required in this
 study. Further, no sedation will be given to subjects receiving a replacement IPG, which can
 cause minor discomfort or anxiety in some patients. Subjects undergoing surgery for electrode
 implantation will receive monitored anesthesia care (MAC), in which sedation will be
 administered as needed, such that subjects are still responsive and pathological motor
 symptoms (tremor or bradykinesia) are present.

 Following surgery, the subject's pre-operative MRI and post-operative high-resolution CT
 scans may be used to determine the location of DBS electrode contacts within the brain.
 However, participation in the study will not modify imaging procedures needed for standard
 care, and placement of the electrode during DBS implant surgery will not be altered by the
 research study.

 There will be no additional costs to subjects as a result of being in this study. Additional
 operating room costs will be covered by institutional and/or grant resources.
Inclusion Criteria:

 -  Diagnosis of Parkinson's Disease (PD), Essential Tremor (ET) or Multiple Sclerosis
 (MS)

 -  Scheduled to undergo Deep Brain Stimulation (DBS) electrode implant or implanted pulse
 generator (IPG) replacement surgery

 -  Neurologically stable

 -  Able to understand the study and consent form

 Exclusion Criteria:

 -  Inability to execute the motor tasks during the study

 -  Inability to tolerate withholding anti-parkinsonian and/or anti-tremor medications

 -  Clinically ineffective DBS