Clinical trial NCT01839396: Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
Official title: Implantable Neurostimulator for the Treatment of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Intrepid, Vercise, PD, DBS, Boston Scientific
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2013-04-24
Enrollment: 313
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.

Detailed description: The study is multi-center, prospective, double-blind, randomized (3:1) controlled trial.

GUIDE XT may be used for planning of programming as needed.

Eligibility criteria: Key Inclusion Criteria:

* Diagnosis of bilateral idiopathic PD (H\&Y ≥ 2) with a duration of PD ≥ 5 years.
* Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy.
* Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.

Key Exclusion Criteria:

* Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
* Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol
* Any other active implanted devices including neurostimulators and /or drug delivery pumps
* Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure.
* Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
* A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.

Primary outcomes:
measure: Change in ON Time as Measured by Parkinson's Disease Diary
timeFrame: From baseline to 12 weeks post-randomization
Secondary outcomes:
measure: Secondary Endpoints
timeFrame: From baseline to 12 weeks post-randomization
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Muhammad Ali Parkinson Research Center and Movement Disorders Clinic
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente, Sacramento
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Englewood
country: United States
facility: Carepoint, PC d/b/a Blue Sky Neurology
state: Colorado
city: Gainesville
country: United States
facility: University of Florida Shands Hospital
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic, Jacksonville
state: Florida
city: Miami
country: United States
facility: University of Miami, School of Medicine
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New York
country: United States
facility: NYU Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Minnesota, Neurology Department
name: Jerrold Vitek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiry of California, San Francisco, Surgical Movement Disorders Clinic
name: Philip Starr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vitek JL, Jain R, Chen L, Troster AI, Schrock LE, House PA, Giroux ML, Hebb AO, Farris SM, Whiting DM, Leichliter TA, Ostrem JL, San Luciano M, Galifianakis N, Verhagen Metman L, Sani S, Karl JA, Siddiqui MS, Tatter SB, Ul Haq I, Machado AG, Gostkowski M, Tagliati M, Mamelak AN, Okun MS, Foote KD, Moguel-Cobos G, Ponce FA, Pahwa R, Nazzaro JM, Buetefisch CM, Gross RE, Luca CC, Jagid JR, Revuelta GJ, Takacs I, Pourfar MH, Mogilner AY, Duker AP, Mandybur GT, Rosenow JM, Cooper SE, Park MC, Khandhar SM, Sedrak M, Phibbs FT, Pilitsis JG, Uitti RJ, Starr PA. Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomised, sham-controlled study. Lancet Neurol. 2020 Jun;19(6):491-501. doi: 10.1016/S1474-4422(20)30108-3. Epub 2020 May 26.