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.

Parkinson's Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284699
• Other study ID #: 2009-A01227-50
• Secondary ID: 2009/34
• Status: Completed
• Phase: N/A
• Start date: February 4, 2011
• Est. completion date: April 12, 2023

Study information

• Verified date: April 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 12, 2023
• Est. primary completion date: May 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• patients presenting with contraindications for anaesthesia or electrode implantation

Exclusion Criteria:

• contraindications for a surgical treatment

• Pregnant or breast-feeding women

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Gamma Knife radiosurgery
For patients presenting a contraindications for anaesthesia or electrode implantation, operate their brain without opening the skull without infection or bleeding risk.

Locations

Country	Name	City	State
France	Assistance Publique - Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48 months