Sub-thalamic Nucleus Stimulation in Parkinson Disease (PARKEO)

August 22, 2017 updated by: University Hospital, Bordeaux

Sub-thalamic Nucleus Stimulation in Parkinson Disease: Comparison of a Two-steps Electrophysiological Approach Under Local and General Anesthesia and a One-step Approach Under General Anesthesia

Deep brain stimulation (DBS) is an established procedure for the symptomatic treatment of Parkinson's disease. This procedure performed in two steps using electrophysiology. This study is a prospective, randomized and monocentric study to compare two DBS procedures with or without electrophysiology.

A better control of targeting and trajectory is necessary before not using electrophysiology, which is the reference procedure. A new definition of sub thalamic nuclei with new MRI stereotactic landmarks, the use of surgical robot (Neuromata Renishaw) and the use of operative imaging (O-arm) could allow the implantation of electrode in sub-thalamic nuclei without the need of electrophysiology.

Two groups of patients will be followed: a first group of patients with a procedure under general anesthesia alone without electrophysiological stimulation and a second smaller group of patients with a first step of electrode implantation under awake surgery with electrophysiological stimulation followed by a second step under general anesthesia for the implantation of stimulator.

Clinical results will be assessed at 6 months after implantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Deep brain stimulation (DBS) is an established procedure for the symptomatic treatment of Parkinson's disease. This procedure performed in two steps using electrophysiology (Limousin et al., 1995) to register the activity of the sub-thalamic nucleus and test the efficacy of stimulation while the patient is awake. A second procedure is needed a few days later to implant the stimulation device under general anaesthesia. The duration of the first procedure is long because of a necessary time of deep stimulation to control the target before definitive implantation. Firstly, the long time of procedure causes pain for the patient. Secondly, the time of procedure, and thus of electrophysiology, is correlated with a rate of device infection of 5 % - 6 % (Hamani et al., 2006; Kenney et al., 2007; Sillay et al., 2008; Doshi et al., 2011). Thirdly, the introduction of several microelectrodes increases the risk of operative and postoperative haemorrhages, estimated at 1 % (Kenney et al., 2007; Sansur et al., 2007; Voges et al., 2007; Bhatia et al., 2008). Moreover, Foltynie et al. (2011) described 12/79 patients treated under general anaesthesia alone with the same post operative results than those who were firstly treated under local anaesthesia.

A better control of targeting and trajectory is necessary before not using electrophysiology, which is the reference procedure. A new definition of sub thalamic nuclei with new MRI stereotactic landmarks, the use of surgical robot (Neuromata Renishaw) and the use of operative imaging (O-arm) could allow the implantation of electrode in sub-thalamic nuclei without the need of electrophysiology. (Caire et al. 2012, In press).

This study is a prospective, randomized and monocentric study. The randomization will be made according to a ratio 2:1 in favour of the technique without electrophysiology. Two groups of patients will be followed: a first group of patients with a procedure under general anesthesia alone without electrophysiological stimulation and a second smaller group of patients with a first step of electrode implantation under awake surgery with electrophysiological stimulation followed by a second step under general anesthesia.

After a preoperative assessment, a end-point evaluation at 6 months after implantation will complete the follow-up.

The stimulation efficacy (UPDRS-3) and the post operative adverse effects will be noticed.

This study will also evaluate the occurrence of a post-traumatic stress disorder (PTSD) in Parkinson disease patients operated under deep brain stimulation.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age : between 18 and 70 years old
  • Parkinson disease in fluctuation state despite the use of an optimal medical treatment
  • Dopa sensibility higher than 50% with the L-DOPA test
  • Normal MRI
  • Mattis Scale > 130
  • Surgical indication approved by a multidisciplinary team
  • Patient covered by a social insurance
  • Informed consent signed by patient and investigator

Exclusion Criteria:

  • Patients with surgical or anesthetic contraindications
  • Cerebral atrophy or signal abnormalities on MRI
  • Severe Depressive State : The Beck Scale score > 15
  • Women of childbearing potential without efficient contraceptive mean
  • Need of long-term antithrombotic treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: New targeting procedure without electrophysiology
Patients with the high precision procedure under general anesthesia alone without electrophysiological stimulation
Procedure: New targeting procedure without electrophysiology
It is a neurosurgical procedure of electrodes implantation in the sub thalamic nuclei under general anaesthesia using a new targeting procedure without electrophysiology.
ACTIVE_COMPARATOR: Classical neurosurgical procedure
patients with a first step of electrode implantation under awake surgery with electrophysiological control followed by a second step under general anesthesia
Procedure: Classical neurosurgical procedure
It is a neurosurgical procedure of electrodes implantation in the sub thalamic nuclei under awake surgery with electrophysiological control. A second surgical step is performed to implant the subcutaneous stimulation device, under general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the ratio of preoperative and postoperative UPDRS 3 score
Time Frame: 6 month
The primary outcome is defined after six months of sub-thalamic nucleus deep brain stimulation with the ratio of preoperative and postoperative UPDRS 3 score. The ratio is : (post operative UPDRS 3 OFF medicine and OFF stimulation- post operative UPDRS 3 OFF medicine ON stimulation)/(post operative UPDRS 3 OFF medicine OFF stimulation)
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stimulation efficacy
Time Frame: 6 month
Efficacy with the ratio : (Preoperative UPDRS 3 OFF medicine - post operative UPDRS 3 OFF medicine ON stimulation)/( preoperative UPDRS 3 OFF medicine )
6 month
The variance of improvement mean for the "high precision" technique
Time Frame: 6 month
The variance of improvement mean for the "high precision" technique
6 month
Percentage of patients with an improvement of UPDRS III score
Time Frame: 6 month
Percentage of patients with an improvement of UPDRS III score of 35%, 50% et 65%
6 month
The Calculated preoperative and post operative (6 months) equivalent dose of L-DOPA and the decrease of between preoperative and post operative period (6 months).
Time Frame: 6 month
The Calculated preoperative and post operative (6 months) equivalent dose of L-DOPA and the decrease of between preoperative and post operative period (6 months).
6 month
Percentage of patients with failure of the new surgical technique defined with an improvement of less than 35 % with the UPDRS 3 score and an electrode located more than 4 mm from the target
Time Frame: 6 month
Percentage of patients with failure of the new surgical technique defined with an improvement of less than 35 % with the UPDRS 3 score and an electrode located more than 4 mm from the target
6 month
Quality of Life
Time Frame: 6 month
Quality of Life scale : PDQ-39
6 month
Non motor items of UPDRS score in the high precision technique under general anesthesia alone
Time Frame: 6 month
Non motor items of UPDRS score in the high precision technique under general anesthesia alone
6 month
Adverse effects and complications
Time Frame: 6 month
Adverse effects and complications : infection, haemorrhages, paresthesia, hypophonia and dyskinesia
6 month
Percentage of improvement in patients with the reference technique
Time Frame: 6 month
Percentage of improvement in patients with the reference technique (electrophysiological approach in awake surgery)
6 month
Compare the technical feasibility for both surgeries based on the number of electrodes implanted in the target
Time Frame: after surgery
Compare the technical feasibility for both surgeries based on the number of electrodes implanted in the target
after surgery
Operative and postoperative surgical adverse effects.
Time Frame: 6 month
Operative and postoperative surgical adverse effects.
6 month
Evaluate the influence of two operative procedures on the onset and maintenance of post-operative PTSD
Time Frame: 6 month
Evaluate the influence of two operative procedures on the onset and maintenance of post-operative PTSD
6 month
Evaluate the influence of two operative procedures on the level of preoperative anxiety and the time course of this anxiety
Time Frame: 1, 3 and 6 month
Evaluate the influence of two operative procedures on the level of preoperative anxiety and the time course of this anxiety
1, 3 and 6 month
Differentiate thymic and cognitive factors potentially predictors of the occurrence of post-surgical PTSD
Time Frame: 6 month
Differentiate thymic and cognitive factors potentially predictors of the occurrence of post-surgical PTSD
6 month
Evaluate the long-term effects of the two operating procedures on thymic and cognitive state
Time Frame: 6 month
Evaluate the long-term effects of the two operating procedures on thymic and cognitive state
6 month
Evaluate the dose of irradiation received by patients during surgery in both procedures
Time Frame: During surgery
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Emmanuel CUNY, MD-PhD, University Hospital Bordeaux, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 11, 2013

Primary Completion (ACTUAL)

September 9, 2016

Study Completion (ACTUAL)

September 9, 2016

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

March 20, 2013

First Posted (ESTIMATE)

March 22, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 24, 2017

Last Update Submitted That Met QC Criteria

August 22, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2012/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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