Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
INTREPID
Implantable Neurostimulator for the Treatment of Parkinson's Disease
2 other identifiers
interventional
313
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2013
Longer than P75 for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2013
CompletedFirst Posted
Study publicly available on registry
April 24, 2013
CompletedStudy Start
First participant enrolled
May 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2016
CompletedResults Posted
Study results publicly available
August 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2022
CompletedJuly 13, 2023
July 1, 2023
3.6 years
April 22, 2013
February 16, 2018
July 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in ON Time as Measured by Parkinson's Disease Diary
Difference in the mean change from baseline to 12 weeks post-randomization between the active and control groups in the ON time as measured by Parkinson's diary. Positive indicates improvement
From baseline to 12 weeks post-randomization
Secondary Outcomes (1)
Secondary Endpoints
From baseline to 12 weeks post-randomization
Study Arms (2)
Medium continuous dose of stimulation
ACTIVE COMPARATORSubjects in this arm will receive stimulation settings at a medium continuous dose of Deep Brain stimulation that may have been effective in previous DBS patients.
Low intermittent dose of stimulation
SHAM COMPARATORSubjects in this arm will receive stimulation settings at a lower intermittent dose of Deep Brain stimulation which is less likely to be effective.
Interventions
The Verciseâ„¢ DBS system will be implanted in subjects in both study arms. Stimulation parameters will vary depending on the study arm assignment. All subjects will receive therapeutic settings at the end of the blinded period.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Muhammad Ali Parkinson Research Center and Movement Disorders Clinic
Phoenix, Arizona, 85013, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Kaiser Permanente, Sacramento
Sacramento, California, 95825, United States
University of California, San Francisco
San Francisco, California, 94115, United States
Carepoint, PC d/b/a Blue Sky Neurology
Englewood, Colorado, 80113, United States
University of Florida Shands Hospital
Gainesville, Florida, 32610, United States
Mayo Clinic, Jacksonville
Jacksonville, Florida, 32224, United States
University of Miami, School of Medicine
Miami, Florida, 33136, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Kansas Hospital
Kansas City, Kansas, 66160, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Albany Medical Center
Albany, New York, 12208, United States
NYU Medical Center
New York, New York, 10016, United States
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati
Cincinnati, Ohio, 45129, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Related Publications (1)
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.
PMID: 32470421DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roshini Jain, Director of Clinical Sciences
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Jerrold Vitek, MD, PhD
University of Minnesota, Neurology Department
- PRINCIPAL INVESTIGATOR
Philip Starr, MD, PhD
Universiry of California, San Francisco, Surgical Movement Disorders Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2013
First Posted
April 24, 2013
Study Start
May 17, 2013
Primary Completion
December 27, 2016
Study Completion
December 5, 2022
Last Updated
July 13, 2023
Results First Posted
August 15, 2018
Record last verified: 2023-07