Safety and Efficacy of Motor Cortex Stimulation in the Treatment of Advanced Parkinson Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00159172
First received: September 7, 2005
Last updated: March 5, 2007
Last verified: September 2005
  Purpose

The purpose of this study is to determine whether motor cortex stimulation, a mildly invasive surgical procedure, is safe and effective in advanced stage Parkinsonian patients who display side effects with dopaminergic treatment.


Condition Intervention Phase
Parkinson Disease
Device: Motor cortex stimulation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
Official Title: Phase 1 Study of Motor Cortex Stimulation in the Treatment of Advanced Parkinson Disease

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Safety of the treatment and Unified Parkinson Disease Rating Scale (UPDRS) III 1 month following constant stimulation with and without motor cortex stimulation when the patient has no anti-parkinsonian drug for 12 hours

Secondary Outcome Measures:
  • Quality of life: Parkinson's Disease Questionnaire 39 (PDQ39) scores
  • Anti-parkinsonian drug doses (equivalent L-dopa)
  • Results of motor activation study in positron emission tomography (PET) scan
  • Results of the different neuropsychological tests
  • Video movement analysis

Estimated Enrollment: 10
Study Start Date: September 2005
Estimated Study Completion Date: May 2008
Detailed Description:

Advanced stage of Parkinson disease (PD) is a difficult condition to treat, especially after several years of dopaminergic drugs. Recent development of neurosurgical techniques using deep brain stimulation leads has shown good behavioral results in these advanced PD patients. However, the placement of a stimulation lead in the subthalamic nucleus is a complex, invasive, and long surgical procedure. Such intervention requires a sophisticated technical environment, including a stereotactic magnetic resonance imaging (MRI) exam, associated with per-operative electrophysiological exploration of deep brain structures. This surgical treatment can therefore be indicated only for a few selected patients, and cannot be offered to a large proportion of patients among the potential candidates (estimation of 5000 patients in France). Thus, there is a need to develop therapeutic alternatives that would be technically and practically more convenient, less invasive, and that could be offered to a larger number of patients. Several clinical studies, including one led by our group, have already demonstrated that transcranial magnetic cortical stimulation could improve bradykinesia and shorten motor reaction time in patients with Parkinson disease. The clinical benefit was however moderate, and transient, probably because the stimulating sessions were too short in duration.

A prolonged effect could be obtained with continuous cortical stimulation. Such cortical stimulation has already been developed with good clinical tolerance in our hospital since 1991 for chronic neuropathic pain syndromes. In a non-human primate model of late stage Parkinson disease, we have recently demonstrated that prolonged primary motor cortex stimulation significantly improved both akinesia and bradykinesia.

The primary objective of this pilot study will be to evaluate the tolerance and efficacy of chronic stimulation of the primary motor cortex in 10 patients suffering from advanced stage Parkinson disease, despite the optimisation of dopaminergic treatment. The expected benefit for the patient will be gait improvement, increased movement velocities, and finally a better quality of life associated with reduction in dopaminergic medication and low per-operative morbidity risk.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 70 years
  • Idiopathic Parkinson disease, for at least 5 years of evolution
  • Asymmetric akinetic-rigid form, with symptoms predominant in the right side of the body (stimulator will be implanted on the left side).
  • Functional impairment score in off stage (no drug treatment) of 3-4 according to the Hoehn and Yahr scale
  • UPDRS III score > 40 in off-drug stage.
  • UPDRS III score with L-dopa treatment improved by at least 50% compared to UPDRS III score in off-drug stage

Exclusion Criteria:

  • Age superior to 70 years
  • Adult patients under guardianship
  • Previous neurosurgical operation(s)
  • Previous partial or generalised seizures
  • Mini Mental Status (MMS) score  24 or Mattis score < 130 or Montgomery-Asberg Depression Rating Scale (MADRS) depression score > 20.
  • Presence of signal abnormalities on T1- and T2- MRI sequences
  • Abnormalities in general exam or biological constants (hemogram, ionogram, hepatic or kidney dysfunction) with a higher surgical risk
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159172

Contacts
Contact: Stephane Palfi, MD, PhD 33149812203 stephane.palfi@hmn.aphp.fr

Locations
France
Neurosurgical Department Henri Mondor Hospital Recruiting
Creteil, France, 94100
Contact: Yves Kéravel, MD    33149812201      
Sub-Investigator: Philippe Remy, MD, PhD         
Sub-Investigator: Jean Marc Gurruchaga, MD         
Sub-Investigator: Jean Paul N'Guyen, MD         
Sub-Investigator: Jean Pascal Lefaucheur, MD, PhD         
Sub-Investigator: Pierre Brugière, MD         
Sub-Investigator: Anne Catherine Bachoud-Levy, MD, PhD         
Sub-Investigator: Yves Kéravel, MD         
Sub-Investigator: Patrick Maison, MD         
Sub-Investigator: Marc Peschanski, PhD         
Sub-Investigator: Gilles Fenelon, MD         
Principal Investigator: Stephane Palfi, MD, PhD         
Sub-Investigator: Pierre Albaladejo, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Stephane Palfi, MD, PhD Paris 12 University- APHP
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00159172     History of Changes
Other Study ID Numbers: Parkostim
Study First Received: September 7, 2005
Last Updated: March 5, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Advanced parkinson disease
Stimulation
Motor Cortex
Parkinson disease C10.574.812
Electric Stimulation Therapy E02.831.580.438
Neuronavigation E05.873.249

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 18, 2014