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.
|ClinicalTrials.gov Identifier: NCT01284699|
Recruitment Status : Unknown
Verified August 2014 by Assistance Publique Hopitaux De Marseille.
Recruitment status was: Recruiting
First Posted : January 27, 2011
Last Update Posted : August 29, 2014
|Condition or disease||Intervention/treatment|
|Parkinson's Disease With Inclusion Criteria for STN Deep Brain Stimulation Presenting a Contraindication to Intracerebral Electrode Implantati||Procedure: Gamma Knife radiosurgery|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||April 2010|
|Estimated Primary Completion Date :||April 2015|
Procedure: Gamma Knife radiosurgery
- Evaluation of the safety and efficacy [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284699
|Contact: Jean-Marie REGIS, Professor||+334 91 38 65 64||jean-marie.REGIS@ap-hm.fr|
|Assistance Publique - Hopitaux de Marseille||Recruiting|
|Contact: Jean-Marie REGIS, Professor +334 91 38 65 64 jean-marie.REGIS@ap-hm.fr|
|Principal Investigator:||Jean -Marie REGIS, Professor||APHM|