Pedunculo-Pontin Nucleus (PPN) - Deep Brain Stimulation (DBS) in Gait and Balance Disturbance in Parkinson's Disease (PPN-GAB-PARK Study)

NCT00821743 | Unknown Phase 1

• 1 other identifier: PPN-GAB-PARK study
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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 generate a loss of autonomy and traumatic complications. Improvement of these axial signs by deep brain stimulation (DBS) of the pedunculo-pontin nucleus (PPN) has been described for a small number of patients. The objectives of the present prospective monocentric pilot study are to determine the optimal stimulation parameters of PPN-DBS, to evaluate the long term tolerance and the effect of PPN-DBS on axial signs and quality of life in five patients with severe PD. The use of detailed clinical rating scales and quantitative computer-based gait analysis will allow to identify the optimal stimulation parameters and relevant clinical efficacy parameters, mandatory for the design of further comparative large-scale studies.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Primary endpoint will be the optimal parameters of PPN-DBS, defined as those leading to the best improvement of posture, balance and gait disturbance

  at day 0, day 7, 6 months, year 1 and year 2

Secondary Outcomes (6)

• Efficacy of PPN-DBS on disturbance of posture, balance and gait

  at day 0, day 7, 6 months, year 1 and year 2

• Long term tolerance will be assessed by general and neurological examination, neuro-psychological tests (MMS, Mattis-DRS, Score fontal, BREF, MADRS) and by assessment of adverse events;

  at day 0, day 7, 6 months, year 1 and year 2

• the components of gait that are most improved by PPN-DBS will be determined using computer-based systems (GAITRite and VICON);

  at day 0, day 7, 6 months, year 1 and year 2

• evaluation of unilateral versus bilateral stimulation will be done during the double-blind assessment of all efficacy criteria;

  at day 0, day 7, 6 months, year 1 and year 2

• effects of PPN-DBS on other PD symptom will be assessed using UPDRS and Hoehn and Yahr's staging;

  at day 0, day 7, 6 months, year 1 and year 2

Study Arms (1)

1

OTHER

The DBS electrodes (model 3389, Medtronic) will be stereotactically implanted bilaterally in the PPN, according to the technique usually used for STN-DBS, and connected to the subcutaneously implanted stimulator (Kinetra, Medtronic).

Device: Deep brain stimulation electrode

Interventions

Deep brain stimulation electrode DEVICE

The DBS electrodes (model 3389, Medtronic) will be stereotactically implanted bilaterally in the PPN, according to the technique usually used for STN-DBS, and connected to the subcutaneously implanted stimulator (Kinetra, Medtronic).

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Neurology, Neurosugery of Nice University Hospital

Nice, 06000, France

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Denys FONTAINE, PhD

  Department of neurosurgery, CHU de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denys FONTAINE, PhD

CONTACT

04 92 03 84 50; fontaine.d@chu-nice.fr

Caroline BAYREUTHER, PhD

CONTACT

04 92 03 78 96; bayreuther.c@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2009
• First Posted: January 13, 2009
• Study Start: March 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 24, 2013

Record last verified: 2010-03

Locations

FR (1)