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.

Not Applicable

Completed

• Conditions: With Inclusion Criteria for STN Deep Brain Stimulation; Presenting a Contraindication to Intracerebral Electrode Implantati; Parkinson's Disease

• Registration Number: NCT01284699
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Study Timeline

• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Study Start: 2011-02-04
• Primary Completion: 2017-05-04
• Status Verified: 2023-04
• Study Completion: 2023-04-12
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• patients presenting with contraindications for anaesthesia or electrode implantation

Exclusion Criteria

• contraindications for a surgical treatment
• Pregnant or breast-feeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluation of the safety and efficacy	48 months	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.

Trial Locations

Locations (1)

Assistance Publique - Hopitaux de Marseille; 🇫🇷 Marseille, France