Evaluation of the Safety and Efficacy of Bilateral Subthalamic Nucleus (SNT) Radiosurgery in Idiopathic Severe Parkinson's Disease Fulfilling Inclusion Criteria for STN Deep Brain Stimulation and Presenting With a Contraindication to Intracerebral Electrode Implantation.
Primary Purpose
Parkinson's Disease, With Inclusion Criteria for STN Deep Brain Stimulation, Presenting a Contraindication to Intracerebral Electrode Implantati
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Gamma Knife radiosurgery
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson, contraindication to Intracerebral electrode implantation, Gamma Knife radiosurgery
Eligibility Criteria
Inclusion Criteria:
- patients presenting with contraindications for anaesthesia or electrode implantation
Exclusion Criteria:
- contraindications for a surgical treatment
- Pregnant or breast-feeding women
Sites / Locations
- Assistance Publique - Hopitaux de Marseille
Outcomes
Primary Outcome Measures
Evaluation of the safety and efficacy
Feasibility of this step is mandatory on the organization of a true randomized comparative trial witch should bring a higher lever of evidence, but in the present state immature from ethical point of view.
Secondary Outcome Measures
Full Information
NCT ID
NCT01284699
First Posted
January 26, 2011
Last Updated
April 12, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT01284699
Brief Title
Evaluation of the Safety and Efficacy of Bilateral Subthalamic Nucleus (SNT) Radiosurgery in Idiopathic Severe Parkinson's Disease Fulfilling Inclusion Criteria for STN Deep Brain Stimulation and Presenting With a Contraindication to Intracerebral Electrode Implantation.
Official Title
Evaluation of the Safety and Efficacy of Bilateral Subthalamic Nucleus (SNT) Radiosurgery in Idiopathic Severe Parkinson's Disease Fulfilling Inclusion Criteria for STN Deep Brain Stimulation and Presenting With a Contraindication to Intracerebral Electrode Implantation.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 4, 2011 (Actual)
Primary Completion Date
May 4, 2017 (Actual)
Study Completion Date
April 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of our trial is to evaluate the tolerance and efficacy of the STN radiosurgery in Parkinsonian patients presenting with the inclusion criteria for the STN stimulation but presenting also with clear contraindications to the implantation of the deep brain electrodes.
Detailed Description
Subthalamic nucleus (SNT) deep brain stimulation (DBS) is the reference treatment for severe drug resistant Parkinson's disease, responsible to dopaminergic therapy, to the state of complication. The efficacy of this therapeutic approach has transformed the functional prognosis of these patients. Unfortunately, those of the patients presenting with contraindications for anaesthesia or electrode implantation are excluded of these therapeutic hope.
Gamma Knife radiosurgery is a neurosurgical procedure going to operate in the brain of the patients without opening the skull without infection or bleeding risk.
Gamma Knife radiosurgical treatment will be done in two separate times (GK1 and GK2). Treatment of the second side (GK2) will be done at least 12 months after the treatment of the first side (GK1), in the same methodology as the first treatment. The major risk of onset of acute ballism although low is planned to be managed by the standard protocol by the recruiting team involved in the trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, With Inclusion Criteria for STN Deep Brain Stimulation, Presenting a Contraindication to Intracerebral Electrode Implantati
Keywords
Parkinson, contraindication to Intracerebral electrode implantation, Gamma Knife radiosurgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Gamma Knife radiosurgery
Intervention Description
For patients presenting a contraindications for anaesthesia or electrode implantation, operate their brain without opening the skull without infection or bleeding risk.
Primary Outcome Measure Information:
Title
Evaluation of the safety and efficacy
Description
Feasibility of this step is mandatory on the organization of a true randomized comparative trial witch should bring a higher lever of evidence, but in the present state immature from ethical point of view.
Time Frame
48 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients presenting with contraindications for anaesthesia or electrode implantation
Exclusion Criteria:
contraindications for a surgical treatment
Pregnant or breast-feeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean -Marie REGIS, Professor
Organizational Affiliation
APHM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique - Hopitaux de Marseille
City
Marseille
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Safety and Efficacy of Bilateral Subthalamic Nucleus (SNT) Radiosurgery in Idiopathic Severe Parkinson's Disease Fulfilling Inclusion Criteria for STN Deep Brain Stimulation and Presenting With a Contraindication to Intracerebral Electrode Implantation.
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