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Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease (INTREPID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01839396
Recruitment Status : Completed
First Posted : April 24, 2013
Results First Posted : August 15, 2018
Last Update Posted : May 19, 2023
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: Deep Brain Stimulation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 313 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Implantable Neurostimulator for the Treatment of Parkinson's Disease
Actual Study Start Date : May 17, 2013
Actual Primary Completion Date : December 27, 2016
Actual Study Completion Date : December 5, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Medium continuous dose of stimulation
Subjects 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.
 Device: Deep Brain Stimulation
The Vercise™ 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.
Other Name: Vercise™ Deep Brain Stimulation (DBS) system.
Sham Comparator: Low intermittent dose of stimulation
Subjects in this arm will receive stimulation settings at a lower intermittent dose of Deep Brain stimulation which is less likely to be effective.
 Device: Deep Brain Stimulation
The Vercise™ 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.
Other Name: Vercise™ Deep Brain Stimulation (DBS) system.


Outcome Measures
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Primary Outcome Measures :
  1. Change in ON Time as Measured by Parkinson's Disease Diary [ Time Frame: From baseline to 12 weeks post-randomization ]
    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


Secondary Outcome Measures :
  1. Secondary Endpoints [ Time Frame: From baseline to 12 weeks post-randomization ]

    Change in Unified Parkinson's Disease Rating Scale (UDPRS) Part III (stim on/meds off) from baseline to 12 weeks post randomization.

    Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state.



Eligibility Criteria
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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839396


Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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. Erratum In: Lancet Neurol. 2020 Sep;19(9):e8.

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01839396    
Other Study ID Numbers: G120075
CDM00049710/90876693 ( Other Identifier: BSC protocol number )
First Posted: April 24, 2013    Key Record Dates
Results First Posted: August 15, 2018
Last Update Posted: May 19, 2023
Last Verified: May 2023
Keywords provided by Boston Scientific Corporation:
Intrepid, Vercise, PD, DBS, Boston Scientific
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases