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TerminatedNCT02402569SIV2Updated Jan 9, 2019

Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease

An Early Phase 1 interventional study of 32 channels Deep Brain Stimulator in Parkinson Disease, sponsored by University Hospital, Grenoble. Terminated at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-01-09.

Sponsored by University Hospital, Grenoble · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This study aims to demonstrate innocuity and feasibility of deep brain stimulation with a multi-electrodes set.

Read the detailed description

Bilateral stimulation in subthalamic nucleus with the multi-electrodes set will be compared with single electrode.

02

Conditions studied

  • Parkinson Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 2 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • more or equal than 18 years old and less than 70 years
  • patient affiliated to social security or similarly regime
  • informed consent form signed
  • parkinson disease (UPDRS III20 score up than 30/108 except for severe tremors)
  • motor and non motor dysfunctions
  • pre-operative cerebral MRI without lesion
  • without chirurgical contraindications
  • without psychiatric disease

Exclusion criteria

Exclusion Criteria:

  • Pregnant women and lactating mothers
  • Ward of court or under guardianship
  • Adult unable to express their consent
  • Person deprived of freedom by judicial or administrative decision
  • Person hospitalized without their consent
  • Person under legal protection
  • Person with carcinological antecedent during precedent 5 years
  • Chirurgical or MRI contraindications
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Multi-electrodes / single electrode

    Multi stimulation / single stimulation

    Device: 32 channels Deep Brain Stimulator

  • Experimental
    Single-electrode / Multi electrodes

    Single stimulation / Multi stimulation

    Device: 32 channels Deep Brain Stimulator

Interventions

  • Device32 channels Deep Brain Stimulator
06

What researchers measure

Primary outcomes

  1. Safety, as measured by Number of Participants with Adverse Events

    Number of Participants with Adverse Events

    Time frame: 3 months

Secondary outcomes

  1. Neurologic evaluation

    Change in motor and non-motor symptoms assessment with neurologic scales

    Time frame: 3 months

07

Study locations

1 site
  • CLINATEC
    Grenoble, 38000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02402569
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Mar 30, 2015
Start date
Dec 2014
Primary completion
Dec 2018
Completion
Dec 2018
Last update
Jan 9, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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