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Deep Brain Stimulation

Phase 2

Idiopathic Parkinson's Disease | Unknown | Neurology |Boston Scientific Corporation|Last Updated: Feb 5, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment53

FDA Designations

No designations recorded

Clinical trial landscape

Deep Brain Stimulation · 1 trial · 1 indication

Phase 2 1
NCT01221948Vercise Implantable Stimulator for Treating Parkinson's DiseaseIdiopathic Parkinson's Disease
COMPLETED53 Analytics
PHASE2COMPLETED
Vercise Implantable Stimulator for Treating Parkinson's Disease
Idiopathic Parkinson's Disease
NCT0122194853
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Study Endpoints

Primary Endpoints

Mean Change in UPDRS III Score From Baseline in the Meds Off Condition (no Medications) to 26 Weeks Post First Lead Implantation in the Stim on/Meds Off Condition (Stimulation on and no Medications).
26 weeks post first lead implantation

Unified Parkinson's Disease Rating Scale Part III (UPDRS III) is the motor sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate overall motor disability, including the classic symptoms of Parkinson's Disease. This section has 14 items. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108 with lower scores representing better results.

Secondary Endpoints

Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.
12 and 52 weeks post first lead implantation
Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.
12, 26 and 52 weeks post first lead implantation
Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation
12, 26 and 52 weeks post first lead implantation
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Deep Brain StimulationEXPERIMENTALRechargeable Deep Brain Stimulation System

Interventions

NameTypeDescription
Deep Brain StimulationDEVICERechargeable Deep Brain Stimulation System
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Eligibility Criteria

Age Range21 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites7

Key Inclusion Criteria: 1. Diagnosis of bilateral idiopathic PD with the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia. 2. Duration of bilateral idiopathic PD of more than five years. 3. Stable medications 4. UPDRS subset III score of ≥30 without medication. 5. ...

Countries:AustriaFranceGermanyItalySpainUnited Kingdom
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Frequently asked questions about Deep Brain Stimulation

What is Deep Brain Stimulation used for in Idiopathic Parkinson's Disease?

Deep Brain Stimulation is an investigational therapy being studied for the treatment of Idiopathic Parkinson's Disease. It involves the use of the Vercise Implantable Stimulator, a device designed to deliver electrical stimulation to targeted brain regions. The therapy is currently in Phase 2 clinical development and is not yet approved for this indication.

Who makes Deep Brain Stimulation?

Deep Brain Stimulation is developed by Boston Scientific Corporation, a medical device company traded on the New York Stock Exchange under the ticker BSX. The company is conducting clinical research on the Vercise Implantable Stimulator for the treatment of Idiopathic Parkinson's Disease.

What phase is Deep Brain Stimulation in?

Deep Brain Stimulation is in Phase 2 clinical development for Idiopathic Parkinson's Disease. It is an investigational therapy, meaning it has not yet received regulatory approval and is still being evaluated in clinical trials to assess its safety and effectiveness.

What clinical trials is Deep Brain Stimulation in?

Deep Brain Stimulation is associated with one completed clinical trial, NCT01221948, titled "Vercise Implantable Stimulator for Treating Parkinson's Disease." This Phase 2 study enrolled 53 participants with Idiopathic Parkinson's Disease across Austria, France, Germany, Italy, Spain, and the United Kingdom.

Is Deep Brain Stimulation the same as Vercise Implantable Stimulator?

Deep Brain Stimulation refers to the therapy approach, while Vercise Implantable Stimulator is the specific device used in the clinical trial. The trial NCT01221948 evaluates the Vercise Implantable Stimulator for treating Parkinson's Disease, and the therapy is being developed by Boston Scientific Corporation.