NCT01284699

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
8 days until next milestone

Study Start

First participant enrolled

February 4, 2011

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2017

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2023

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

6.2 years

First QC Date

January 26, 2011

Last Update Submit

April 12, 2023

Conditions

Parkinson's DiseaseWith Inclusion Criteria for STN Deep Brain StimulationPresenting a Contraindication to Intracerebral Electrode Implantati

Keywords

Parkinsoncontraindication to Intracerebral electrode implantationGamma Knife radiosurgery

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Gamma Knife radiosurgeryPROCEDURE

For patients presenting a contraindications for anaesthesia or electrode implantation, operate their brain without opening the skull without infection or bleeding risk.

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients presenting with contraindications for anaesthesia or electrode implantation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hopitaux de Marseille

Marseille, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jean -Marie REGIS, Professor

    APHM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2011

First Posted

January 27, 2011

Study Start

February 4, 2011

Primary Completion

May 4, 2017

Study Completion

April 12, 2023

Last Updated

April 14, 2023

Record last verified: 2023-04

Locations

FR(1)