NCT02402569

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for early_phase_1 parkinson-disease

Timeline
Completed

Started Dec 2014

Longer than P75 for early_phase_1 parkinson-disease

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

4 years

First QC Date

January 30, 2015

Last Update Submit

January 7, 2019

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Safety, as measured by Number of Participants with Adverse Events

    Number of Participants with Adverse Events

    3 months

Secondary Outcomes (1)

  • Neurologic evaluation

    3 months

Study Arms (2)

Multi-electrodes / single electrode

EXPERIMENTAL

Multi stimulation / single stimulation

Device: 32 channels Deep Brain Stimulator

Single-electrode / Multi electrodes

EXPERIMENTAL

Single stimulation / Multi stimulation

Device: 32 channels Deep Brain Stimulator

Interventions

32 channels Deep Brain StimulatorDEVICE
Multi-electrodes / single electrodeSingle-electrode / Multi electrodes

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CLINATEC

Grenoble, 38000, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2015

First Posted

March 30, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 9, 2019

Record last verified: 2019-01

Locations

FR(1)