Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease

Parkinson Disease Clinical Trial

— SIV2  

Official title:

Implantation Feasibility Study of a Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease (Smart in Vivo 2)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02402569
• Other study ID #: SIV2
• Status: Terminated
• Phase: Early Phase 1
• Start date: December 2014
• Est. completion date: December 2018

Study information

• Verified date: January 2019
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to demonstrate innocuity and feasibility of deep brain stimulation with a multi-electrodes set.

Description:

Bilateral stimulation in subthalamic nucleus with the multi-electrodes set will be compared with single electrode.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• more or equal than 18 years old and less than 70 years

• patient affiliated to social security or similarly regime

• informed consent form signed

• parkinson disease (UPDRS III20 score up than 30/108 except for severe tremors)

• motor and non motor dysfunctions

• pre-operative cerebral MRI without lesion

• without chirurgical contraindications

• without psychiatric disease

Exclusion Criteria:

• Pregnant women and lactating mothers

• Ward of court or under guardianship

• Adult unable to express their consent

• Person deprived of freedom by judicial or administrative decision

• Person hospitalized without their consent

• Person under legal protection

• Person with carcinological antecedent during precedent 5 years

• Chirurgical or MRI contraindications

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• 32 channels Deep Brain Stimulator

Locations

Country	Name	City	State
France	CLINATEC	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, as measured by Number of Participants with Adverse Events	Number of Participants with Adverse Events	3 months
Secondary	Neurologic evaluation	Change in motor and non-motor symptoms assessment with neurologic scales	3 months