Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT01909531 |
Other study ID # |
12BN136 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 2013 |
Est. completion date |
December 31, 2023 |
Study information
Verified date |
September 2021 |
Source |
St. Joseph's Hospital and Medical Center, Phoenix |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.