Parkinson's DiseaseINTREPIDNCT01839396
Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
A study testing Deep Brain Stimulation in people with Parkinson's Disease, run by Boston Scientific Corporation at 22 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 313 participants
- Where
- 22 sitesUnited States
- Study dates
- 17 May 2013to 5 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Albany Medical Center
Albany, New York, 12208
Emory University
Atlanta, Georgia, 30322
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University of Cincinnati
Cincinnati, Ohio, 45129
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Carepoint, PC d/b/a Blue Sky Neurology
Englewood, Colorado, 80113
University of Florida Shands Hospital
Gainesville, Florida, 32610
Mayo Clinic, Jacksonville
Jacksonville, Florida, 32224
University of Kansas Hospital
Kansas City, Kansas, 66160
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Miami, School of Medicine
Miami, Florida, 33136
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University
Nashville, Tennessee, 37232
NYU Medical Center
New York, New York, 10016
Muhammad Ali Parkinson Research Center and Movement Disorders Clinic
Phoenix, Arizona, 85013
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Kaiser Permanente, Sacramento
Sacramento, California, 95825
University of Utah
Salt Lake City, Utah, 84132
University of California, San Francisco
San Francisco, California, 94115
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Implantable Neurostimulator for the Treatment of Parkinson's Disease
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Deep Brain Stimulation
- Keywords
- Intrepid, Vercise, PD, DBS, Boston Scientific
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
Also called Vercise™ Deep Brain Stimulation (DBS) system.
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.
| Study group | Role | What they receive |
|---|---|---|
| Medium continuous dose of stimulation | Active comparator | 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. Receives: Device: Deep Brain Stimulation |
| Low intermittent dose of stimulation | Sham comparator | Subjects in this arm will receive stimulation settings at a lower intermittent dose of Deep Brain stimulation which is less likely to be effective. Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to 12 weeks post-randomization
Secondary outcomes (1)
Secondary Endpoints
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.
Measured: From baseline to 12 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study start17 May 2013
- Primary completion27 Dec 2016
- Study completion5 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerrold Vitek, MD, PhD, Principal investigator, University of Minnesota, Neurology DepartmentPhilip Starr, MD, PhD, Principal investigator, Universiry of California, San Francisco, Surgical Movement Disorders Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839396
- Sponsor's protocol ID
- G120075
- Other IDs
- CDM00049710/90876693
- Acronym
- INTREPID
- Status last verified
- Jul 2023
- First submitted
- 22 Apr 2013
- Last updated
- 13 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 32470421
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantable Neurostimulator for the Treatment of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01839396
- Acronym / sponsor ID
- INTREPID / G120075
- Conditions
- Parkinson's Disease
- Keywords
- Intrepid, Vercise, PD, DBS, Boston Scientific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 May 2013 (actual)
- Primary completion
- 27 Dec 2016 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Posted 15 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medium continuous dose of stimulation | Active comparator | Device: Deep Brain StimulationSubjects 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 comparator | Device: Deep Brain StimulationSubjects in this arm will receive stimulation settings at a lower intermittent dose of Deep Brain stimulation which is less likely to be effective. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain StimulationAlso: Vercise™ Deep Brain Stimulation (DBS) system.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. | Device | Low intermittent dose of stimulation, Medium continuous dose of stimulation |
Primary outcome
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
1 secondary outcome
Secondary Endpoints
Time frame: From baseline to 12 weeks post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32470421Vitek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerrold Vitek, MD, PhD principal investigator
University of Minnesota, Neurology Department
Philip Starr, MD, PhD principal investigator
Universiry of California, San Francisco, Surgical Movement Disorders Clinic
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Parkinson's Disease, run by Boston Scientific Corporation at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ON Time as Measured by Parkinson's Disease Diary (time frame: From baseline to 12 weeks post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01839396, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.