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Pedunculopontine Nucleus Stimulation for Gait Disorders in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02055261
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : February 5, 2014
Sponsor:
Information provided by (Responsible Party):
David Grabli, Pitié-Salpêtrière Hospital

Brief Summary:

The appearance of postural instability and gait disorders is a major turning point in the evolution of Parkinson's disease (PD). These axial symptoms are usually unresponsive to L-Dopa and represent a severe impairment for the patients due to frequent falls and reduced outside mobility. There is no effective pharmacological treatment available for these symptoms, and their pathophysiology is not well known : it is currently assumed that non-dopaminergic brainstem lesions participate to axial symptoms in PD. Surgically, these patients cannot benefit from high frequency deep brain stimulation (DBS) of the subthalamic nucleus (STN) since this operation tends to even aggravate axial symptoms unresponsive to L-Dopa in some patients. A dysfunction of the pedunculopontine nucleus (PPN) might be at the origin of these axial symptoms, since the PPN participates in the maintenance of posture and motion in primates. In PD patients, recent reports have suggested that low frequency stimulation of the PPN may equally improve gait and posture. However, these results are debatable due to methodological limitations, insufficient clinical evaluation and uncertain anatomical targeting. Thus, our aim is to propose a low frequency PPN stimulation to six advanced PD patients according to the usual criteria for STN DBS who are, however, unsuitable for this operation due to gait and posture disorders. We will perform a randomized, double-blind and cross over design (two months periods with and without DBS randomly assigned to each patient). The targeting will be allowed by a a three-dimensional and deformable atlas of the basal ganglia fusioned with the stereotaxic magnetic resonance imaging (MRI) of each patient. Evaluations will comprise 1 month before surgery and in "Off" and "On" stimulation condition:

  • clinical motor assessment in both "Off" and "On" drug state, including cardinal parkinsonian signs, gait and balance
  • gait initiation physiological evaluation
  • cognitive and behavioral testing If our hypothesis is confirmed, low frequency PPN stimulation may well represent a substantial improvement of our therapeutic options for advanced PD patients suffering from debilitating gait and posture disorders unresponsive to L-Dopa.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: Low frequency DBS of the pedunculopontine nucleus Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Low Frequency Deep Brain Stimulation of the Pedunculopontine Nucleus on Gait and Balance Disorders of Parkinson's Disease
Study Start Date : May 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
OFF PPN DBS-ON PPN DBS
Patients randomly allocated to the order OFF Low frequency DBS of the pedunculopontine nucleus then ON Low frequency DBS of the pedunculopontine nucleus
Device: Low frequency DBS of the pedunculopontine nucleus
ON PPN DBS - OFF PPN DBS
Patients randomly allocated to the order ON Low frequency DBS of the pedunculopontine nucleus then OFF Low frequency DBS of the pedunculopontine nucleus
Device: Low frequency DBS of the pedunculopontine nucleus



Primary Outcome Measures :
  1. Change of Rating scale for gait evaluation between 'Off stim off drug" and "On stim off drug" conditions [ Time Frame: 4 months and 6 months after surgery ]
    The primary outcome criteria will be the comparison between RSGE total score in obtained 'Off' and 'On' stimulation conditions either at 4 or 6 months after surgery according to the randomized order of the cross-over


Secondary Outcome Measures :
  1. Adverse events records [ Time Frame: 1 month before surgery, 1-2-3-4-5-6 months after surgery ]
  2. Change of UPDRS part 3 score between "Off Stim Off drug" and "ON stim Off drug" conditions [ Time Frame: 4 and 6 months after surgery ]
  3. Change of Rating scale for gait evaluation between 'Off stim on drug" and "On stim on drug" conditions [ Time Frame: 4 and 6 months after surgery ]
  4. Change of UPDRS part 3 score between "Off Stim On drug" and "ON stim On drug" conditions [ Time Frame: 4 and 6 months after surgery ]
  5. Change of UPDRS part 3 score between "Off Stim Off drug" and "No stim Off drug" conditions [ Time Frame: 1 month before surgery and 4 or 6 months after surgery ]
  6. Change of UPDRS part 3 score between "Off Stim On drug" and "No stim On drug" conditions [ Time Frame: 1 month before surgery and 4 or 6 months after surgery ]
  7. Change of Rating scale for gait evaluation between 'Off stim Off drug" and "No stim off drug" conditions [ Time Frame: 1 month before surgery and 4 or 6 months after surgery ]
  8. Change of Rating scale for gait evaluation between 'Off stim On drug" and "No stim on drug" conditions [ Time Frame: 1 month before surgery and 4 or 6 months after surgery ]
  9. Change of Rating scale for gait evaluation between 'On stim Off drug" and "No stim off drug" conditions [ Time Frame: 1 month before surgery and 4 or 6 months after surgery ]
  10. Change of Rating scale for gait evaluation between 'On stim On drug" and "No stim On drug" conditions [ Time Frame: 1 month before surgery and 4 or 6 months after surgery ]
  11. Change of gait physiological parameters between "Off Stim Off drug" and "ON stim Off drug" conditions [ Time Frame: 4 and 6 months after surgery ]
  12. Change of gait physiological parameters between "Off Stim On drug" and "ON stim On drug" conditions [ Time Frame: 4 and 6 months after surgery ]
  13. Change of gait physiological parameters between "No Stim On drug" and "Off stim On drug" conditions [ Time Frame: 1 month before surgery and 4 or 6 months after surgery ]
  14. Change of gait physiological parameters between "No Stim Off drug" and "On stim off drug" conditions [ Time Frame: 1 month before surgery and 4 or 6 months after surgery ]
  15. Change of gait physiological parameters between "No Stim Off drug" and "Off stim off drug" conditions [ Time Frame: 1 month before surgery and 4 or 6 months after surgery ]

Other Outcome Measures:
  1. Changes in sleep architecture between "off stim" and "on stim" conditions [ Time Frame: 4 and 6 months after surgery ]
  2. changes in cognitive evaluation between "Off stim" and 'On stim" conditions [ Time Frame: 4 and 6 months after surgery ]
  3. changes in cognitive evaluation between "No stim" and 'Off stim" conditions [ Time Frame: 1 month before surgery and 4 or 6 months after surgery ]
  4. changes in cognitive evaluation between "No stim" and 'On stim" conditions [ Time Frame: 1 month before surgery and 4 or 6 months after surgery ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parkinson's disease
  • Age < 70 and > = 18 years
  • Improvement > or = 50 % during acute levodopa test
  • Score > or = 2 on item 29 of UPDRS part 3 score obtained in "off" drug state
  • No previous DBS
  • No evidence of atypical parkinsonism
  • No dementia (MATTIS > 129)
  • No psychiatric disease
  • Contraception if woman
  • Informed consent

Exclusion Criteria:

  • Contra indication to surgery
  • Contra indication to MRI
  • Severe life threatening comorbidity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055261


Locations
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France
Hôpital de la Pitié-Salpétrière
Paris, France, 75013
Sponsors and Collaborators
Pitié-Salpêtrière Hospital

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Responsible Party: David Grabli, MD PhD, Pitié-Salpêtrière Hospital
ClinicalTrials.gov Identifier: NCT02055261    
Other Study ID Numbers: RBM C08-07
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases