NCT02402569
Terminated
Early Phase 1
Implantation Feasibility Study of a Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease (Smart in Vivo 2)
University Hospital, Grenoble1 site in 1 country2 target enrollmentDecember 2014
ConditionsParkinson Disease
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Safety, as measured by Number of Participants with Adverse Events
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
This study aims to demonstrate innocuity and feasibility of deep brain stimulation with a multi-electrodes set.
Detailed Description
Bilateral stimulation in subthalamic nucleus with the multi-electrodes set will be compared with single electrode.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Safety, as measured by Number of Participants with Adverse Events
Time Frame: 3 months
Number of Participants with Adverse Events
Secondary Outcomes
- Neurologic evaluation(3 months)
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback?AmputationNCT05505513University of Utah3
Completed
Phase 2
Electrical Stimulation of the Internal Capsule for Intractable Obsessive-compulsive Disorder (OCD)Obsessive-Compulsive DisorderNCT01061983Butler Hospital5
Completed
Phase 2
Electrical Stimulation of the Internal Capsule for Intractable DepressionDepressionNCT01069952Butler Hospital5
Completed
Not Applicable
Deep Brain Stimulation for Alcohol Use DisorderAlcohol Use DisorderNCT05522751Khaled Moussawi3
Terminated
Not Applicable
Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - 301FibromyalgiaNCT02211508Cerephex Corporation236