Clinical trial NCT01909531: Deep Brain Stimulation (DBS) Data Base Study
Official title: Deep Brain Stimulation (DBS) Data Base Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Essential Tremor
Keywords: Deep Brain Stimulation
Parkinsons Disease
Essential Tremor
Asleep DBS
Lead sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sponsor class: OTHER
First posted: 2013-07-26
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's Disease or Essential Tremor who have undergone either awake or asleep DBS surgery performed by Francisco A. Ponce, MD

Brief summary: The primary goal of this study is to evaluate and compare outcomes, trends, and effectiveness of both awake and asleep Deep Brain Stimulation (DBS) surgical treatments, target selection, targeting accuracy and outcomes in patients with Parkinson's disease and Essential tremor.

Detailed description: Deep Brain Stimulation (DBS) surgery is a treatment that can improve some of the motor symptoms associated with several movement disorder diseases. DBS is recommended for patients with Parkinson's disease who respond well to medication, but still experience frequent wearing off of medications with return of symptoms. Patients may also be experiencing troubling medication side effects such as dyskinesias, sleepiness, hallucinations, confusion, and behavioral/personality changes. DBS is also used for patients with Essential tremor who have undergone long trials of medication therapy and are still symptomatic. The goal of DBS surgery is to capture that best response to medication and hold it through the day. The Food and Drug Administration (FDA) approved DBS as a treatment for essential tremor in 1997 and for Parkinson's disease in 2002.

The goal of DBS surgery is to improve the quality of life of patients and their families by reducing motor symptoms such as slowness, stiffness and tremor and possibly reducing medication. In order to help with our understanding of its effects, we will collect information on patients who will be undergoing or have undergone DBS surgery.

St. Joseph's Hospital and Medical Center / Barrow Neurological Institute is one of only a few hospitals in the United States offering a new procedure known as asleep DBS surgery, performed under general anesthesia, as well as the traditional awake DBS procedure; therefore it is important that this new asleep surgery option be studied and compared to awake DBS surgery.

Objectives include:

* Comparison of data collected for both the awake and asleep DBS procedures during the pre-operative and post-operative periods including testing, diagnosis, surgical treatment, target accuracy, complications, motor function and quality of life outcomes.
* Comparison of the differential effects of STN and GPi DBS on gait and balance control
* Investigate the effects of DBS on the saccadic eye movements.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis for Parkinson's Disease or Essential Tremor
* Subject has undergone DBS surgery

Exclusion Criteria:

* Clinical diagnosis for Parkinson's Disease or Essential Tremor
* Subject has not undergone DBS surgery

Primary outcomes:
measure: Data Comparison
timeFrame: Pre-operative through 6 months post operative
Secondary outcomes:
measure: Quantitative Evaluation of Balance and Gait
timeFrame: Pre-operative through 6 months post-operative
Other outcomes:
measure: Quantitative Evaluation of Saccadic Eye Movements
timeFrame: Pre-operartive - 6 months post-operative
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital & Medical Center / Barrow Neurological Institute
state: Arizona
Study officials:
affiliation: St. Joseph's Hospital & Medical Center / Barrow Neurological Institute
name: Francisco A Ponce, MD
role: PRINCIPAL_INVESTIGATOR
References: