Status:
UNKNOWN
Pedunculo-Pontin Nucleus (PPN) - Deep Brain Stimulation (DBS) in Gait and Balance Disturbance in Parkinson's Disease (PPN-GAB-PARK Study)
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Disturbance of posture, gait and balance usually appear several years after Parkinson's disease (PD) onset. These axial signs, generally resistant to conventional drug and non-drug treatment, can gene...
Detailed Description
Parkinson's disease (PD) is a neurodegenerative disorder with an association of akinesia, rigidity and tremor, but also so-called "axial" motor signs (disturbance of posture, gait and balance) that us...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Severe idiopathic Parkinson's disease (stage of Hoehn and Yahr ≥ 3).
- Disease duration ≥ 5 years.
- Predominant axial motor signs (gait and balance disturbance as freezing of gait, postural instability, falls) with disability in daily life, defined by a score UPDRS II 2 of item 13 or 3 of item 14 or 15.
- Axial motor signs resistant to optimal drug and non-drug treatment, including physical therapy and eventually STN-DBS (if STN-DBS is ongoing for at least 1 year and has shown no efficacy on axial motor signs).
- No significant abnormality on brain MRI.
- Non-inclusion criteria
- Patient with non-axial, dopa-responsive motor signs and indication of first line STN-DBS. In case of absence of efficacy of STN-DBS on axial motor signs after one year of stimulation, PPN-DBS may be proposed to these patients.
- Patient with major cognitive disturbances defined by a score Mattis DRS 130 (of 144).
- Pregnant or breast-feeding woman.
- Patient with contraindication for general anaesthesia, a contraindication for surgery (including disorders of haemostasis, or necessity of anticoagulant and antiaggregant drug), or a contraindication for MRI.
- Patient presenting major depression, psychosis or addiction in six months preceding inclusion.
Exclusion
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00821743
Start Date
March 1 2010
End Date
September 1 2013
Last Update
April 24 2013
Active Locations (1)
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1
Neurology, Neurosugery of Nice University Hospital
Nice, France, 06000