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Parkinson's DiseasePhase 1/2NCT02055261

Pedunculopontine Nucleus Stimulation for Gait Disorders in Parkinson's Disease

A Phase 1/2 study testing Low frequency DBS of the pedunculopontine nucleus in people with Parkinson's Disease, run by Pitié-Salpêtrière Hospital at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Low frequency DBS of the pedunculopontine nucleus
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteFrance
Study dates
May 2009to May 2012
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • No dementia (MATTIS > 129)
  • No psychiatric disease
  • Contraception if woman
  • Informed consent

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital de la Pitié-Salpétrière

    Paris, 75013

Other trials in France

About this study

Official title: Effects of Low Frequency Deep Brain Stimulation of the Pedunculopontine Nucleus on Gait and Balance Disorders of Parkinson's Disease

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.
Being tested
Low frequency DBS of the pedunculopontine nucleus
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low frequency DBS of the pedunculopontine nucleusDevice

Study groups in NCT02055261
Study groupRoleWhat they receive
OFF PPN DBS-ON PPN DBSOtherPatients randomly allocated to the order OFF Low frequency DBS of the pedunculopontine nucleus then ON Low frequency DBS of the pedunculopontine nucleus
Receives: Device: Low frequency DBS of the pedunculopontine nucleus
ON PPN DBS - OFF PPN DBSOtherPatients randomly allocated to the order ON Low frequency DBS of the pedunculopontine nucleus then OFF Low frequency DBS of the pedunculopontine nucleus
Receives: Device: Low frequency DBS of the pedunculopontine nucleus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Rating scale for gait evaluation between 'Off stim off drug" and "On stim off drug" conditions

    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

    Measured: 4 months and 6 months after surgery

Secondary outcomes (15)

  1. Adverse events records

    Measured: 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

    Measured: 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

    Measured: 4 and 6 months after surgery

  4. Change of UPDRS part 3 score between "Off Stim On drug" and "ON stim On drug" conditions

    Measured: 4 and 6 months after surgery

  5. Change of UPDRS part 3 score between "Off Stim Off drug" and "No stim Off drug" conditions

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 4 and 6 months after surgery

  12. Change of gait physiological parameters between "Off Stim On drug" and "ON stim On drug" conditions

    Measured: 4 and 6 months after surgery

  13. Change of gait physiological parameters between "No Stim On drug" and "Off stim On drug" conditions

    Measured: 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

    Measured: 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

    Measured: 1 month before surgery and 4 or 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2014 (estimated)
  2. Study startMay 2009
  3. Primary completionMay 2012
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02055261
Sponsor's protocol ID
RBM C08-07
Status last verified
Feb 2014
First submitted
16 Jan 2014
Last updated
5 Feb 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Low frequency DBS of the pedunculopontine nucleus in people with Parkinson's Disease, run by Pitié-Salpêtrière Hospital at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02055261.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2014.

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