NCT01782638

Brief Summary

Deep brain stimulation of STN (subthalamic nucleus) at high frequencies generally improved gait in parkinsonian patients. However, sometimes the investigators observed a gait aggravation either with using high voltage and high frequencies, either because of suboptimal placement of electrode inside Forel H2 field. The most frequent hypothesise to explain this gait aggravation is a modulation of the activity of pedunculopontine nucleus due to a diffusion of the electric stimulation current to the fibbers going near STN area. The primary purpose of this study is to compare the effect of deep brain stimulation with high frequency versus low frequency on gait of patients whatever the electrodes placement (STN ou Forel fields) and whatever the medication condition (with or without treatment).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2013

Completed
Last Updated

February 15, 2024

Status Verified

January 1, 2013

Enrollment Period

8 months

First QC Date

January 21, 2013

Last Update Submit

February 14, 2024

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseDeep brain stimulationGaitFreezingElectrode placements

Outcome Measures

Primary Outcomes (1)

  • The step length (expressed in meter)

    from day 1 (without L Dopa) to day 2 (with L Dopa)

Secondary Outcomes (4)

  • The gait speed

    from day 1 (without L Dopa) to day 2 (with L Dopa)

  • The step cadence

    From day 1 (without L Dopa) to day 2 (with L Dopa)

  • The number of freezing

    from day 1 (without L Dopa) to day 2 (with L Dopa)

  • The UPDRS score

    from day 1 (without L Dopa) to day 2 (with L Dopa)

Study Arms (2)

deep brain stimulation with high frequency

EXPERIMENTAL

The primary purpose of this study is to compare the effect of deep brain stimulation with high frequency vs low frequency on gait of patients whatever the electrodes placement (STN ou Forel fields) and whatever the medication condition (with or without treatment).

Behavioral: deep brain stimulation

low frequency on gait of patients

OTHER

The primary purpose of this study is to compare the effect of deep brain stimulation with high frequency vs low frequency on gait of patients whatever the electrodes placement (STN ou Forel fields) and whatever the medication condition (with or without treatment).

Behavioral: deep brain stimulation

Interventions

deep brain stimulationBEHAVIORAL
deep brain stimulation with high frequencylow frequency on gait of patients

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients :
  • Men or women aged between 45 -85 years
  • Patients with an idiopathic Parkinson's disease according to UKPDSBB criteria
  • Normal neurologic evaluation (except Parkinson's disease)
  • Patient treated with a deep brain stimulation according to the French consensus conference of treatment of Parkinson's disease (Consensus Conference Proceeding, 2000)
  • Affiliated to National Health system
  • Having given their informed consent
  • Healthy subject
  • Men or women aged between 45 -85 years
  • Normal neurologic evaluation
  • Affiliated to National Health system
  • Having given their informed consent

You may not qualify if:

  • Patients :
  • Patients suffering of an atypical Parkinson syndrome
  • Patients with locomotive disorders which can interfere in gait evaluation
  • Patients with dementia (MMS \<24)
  • Under guardianship
  • In excluding period for another study
  • Person who participate to an other study
  • Healthy subject
  • Subject with locomotive disorders which can interfere in gait evaluation
  • Subject with dementia (MMS \<24)
  • Under guardianship
  • In excluding period for another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Emmanuel COUDEYRE

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2013

First Posted

February 4, 2013

Study Start

September 1, 2012

Primary Completion

April 23, 2013

Study Completion

April 23, 2013

Last Updated

February 15, 2024

Record last verified: 2013-01

Locations

FR(1)