Deep Brain Stimulation (DBS) Data Base Study

Parkinson's Disease Clinical Trial

Official title:

Deep Brain Stimulation (DBS) Data Base Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01909531
• Other study ID #: 12BN136
• Status: Enrolling by invitation
• 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
• 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Tremor
• Parkinson Disease
• Parkinson's Disease
• Tremor

Locations

Country	Name	City	State
United States	St. Joseph's Hospital & Medical Center / Barrow Neurological Institute	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Hospital and Medical Center, Phoenix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quantitative Evaluation of Saccadic Eye Movements	Non-invasively record eye movements when patients follow target (light dot on a light bar placed in front of the patients) that jumps, moves back and forth, fixation on target, etc. This data collection will be obtained in a seated position.	Pre-operartive - 6 months post-operative
Primary	Data Comparison	Data comparison for pre-operative testing, diagnosis, surgical treatment, target accuracy, complications and outcomes for patients undergoing DBS surgery will be analyzed.	Pre-operative through 6 months post operative
Secondary	Quantitative Evaluation of Balance and Gait	For the quantitative evaluation of gait and balance control, different parameters of gait and balance will be obtained non-invasively during pre- and post-surgical clinical evaluation sessions. For this data collection, patients will be asked to perform many trials of quiet standing (eyes open and eyes closed conditions), postural shifts, stepping-in-place, and regular and tandem walking. These data will be obtained using a portable gait system (consisted of small light-weight sensors) and force plate setup. During balance tests, the patients will be asked to hold on to railings in case of loss of balance and asked to wear gait belt during these evaluations. A member of the research team will be close to the patient to hold them in case of any loss of balance to avoid falls.	Pre-operative through 6 months post-operative