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Deep Brain Stimulation

Medium continuous dose of stimulation for Parkinson's Disease (INTREPID Trial)

N/A

Waitlist Available

Led By Philip Starr, MD, PhD

Research Sponsored by Boston Scientific Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of bilateral idiopathic PD (H&Y ≥ 2) with a duration of PD ≥ 5 years.

Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 12 weeks post-randomization

Awards & highlights

INTREPID Trial Summary

This trial will test if a Boston Scientific brain stimulator is safe and effective for people with advanced Parkinson's who aren't well controlled with medication.

Eligible Conditions

Parkinson's Disease

INTREPID Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You have persistent disabling Parkinson's disease symptoms or drug side effects (e.g.

INTREPID Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 12 weeks post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 12 weeks post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 12 weeks post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in ON Time as Measured by Parkinson's Disease Diary

Secondary outcome measures

Secondary Endpoints

INTREPID Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Medium continuous dose of stimulationActive Control1 Intervention

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.

Group II: Low intermittent dose of stimulationPlacebo Group1 Intervention

Subjects in this arm will receive stimulation settings at a lower intermittent dose of Deep Brain stimulation which is less likely to be effective.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor

719 Previous Clinical Trials

933,085 Total Patients Enrolled

Philip Starr, MD, PhDPrincipal InvestigatorUniversiry of California, San Francisco, Surgical Movement Disorders Clinic

Jerrold Vitek, MD, PhDPrincipal InvestigatorUniversity of Minnesota, Neurology Department

2 Previous Clinical Trials

101 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current tally of centers conducting this trial?

"As of now, this clinical study is accepting patients from 22 distinct medical centres. These include NYU Medical Centre in New york, University of Florida Shands Hospital in Gainesville, and Muhammad Ali Parkinson Research Center and Movement Disorders Clinic in Phoenix among many others."

Answered by AI

Do applicants above a certain age qualify for this research program?

"This clinical trial's eligibility criteria restricts recruitment to patients between the ages of 22 and 75. By contrast, there are 27 trials open for subjects younger than 18 and 486 studies that accept individuals above 65 years old."

Answered by AI

Are there still open slots for volunteers in this clinical research?

"The data hosted on clinicaltrials.gov affirms that this medical study is not presently enrolling participants. Initially posted in May 2013 and last updated in August 2022, the trial has since been deactivated; however, there are 489 other trials actively recruiting patients at present."

Answered by AI

What requirements must be met to qualify for involvement in this experiment?

"This research project seeks 313 participants with idiopathic Parkinson's disease aged 22-75 to partake. Additionally, patients must demonstrate persistent symptoms or drug side effects despite optimal medical therapy, a condition duration of 5 years and above, comprehend the trial procedures and provide written consent prior to any tests being conducted."

Answered by AI

Recent research and studies

The Lancet NeurologyJournal

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

Vitek, Jerrold L, Roshini Jain, Lilly Chen, Alexander I Tröster, Lauren E Schrock, Paul A House, Monique L Giroux, et al.. 2020. “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”. The Lancet Neurology. Elsevier BV. doi:10.1016/s1474-4422(20)30108-3.

clinicaltrials.govStudy

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

2013. "Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01839396.