NCT00683566

Brief Summary

Neuronal activity in circuits between the basal ganglia (BG) and motor cortical areas is abnormally synchronized and rhythmic. The oscillatory activity prevails at 8-30 Hz in untreated Parkinson's Disease (PD) and its amplitude at both subthalamic and cortical levels inversely correlates with motor impairment. Moreover, these different levels in BG-cortical loops are coherent in this frequency band. The 8-30 Hz activity is suppressed by treatment following treatment with dopaminergic drugs and is partially suppressed prior to and during voluntary movements. An unanswered question is how do BG-cortical loops become so prominently engaged in this oscillatory activity? One possible explanation is that the resonance frequencies of the loops fall in the 8-30 Hz band in the untreated state, so that oscillations in this band are transmitted particularly well. So we hypothesize loop resonances in the 8-30 Hz frequency band at rest, which should be suppressed during movement and following dopaminergic therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable parkinson-disease

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2008

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 23, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 28, 2014

Status Verified

August 1, 2014

Enrollment Period

2 years

First QC Date

February 26, 2008

Last Update Submit

August 27, 2014

Conditions

Keywords

parkinson

Outcome Measures

Primary Outcomes (1)

  • The results are expected to bring further light into the understanding of the mechanisms underlying the propagation of pathological oscillatory activities in PD and may provide a basis for different therapeutic strategies.

    1 day

Study Arms (1)

1

EXPERIMENTAL

A session in condition ON DOPAMINE and the other one in condition OFF DOPAMINE.

Procedure: electrostimulation

Interventions

Stimulate STN (at 0, 5, 10, 15, 20, 25, 30, 40, 70 and 130 Hz) in chronically implanted patients at rest and during simple and complex motor tasks

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson's disease idiopathic evolving for more than 5 years
  • Electrodes of stimulation implanted in 2 nuclei under - thalamic in the service of functional and stereotaxic neurosurgery of the CHU La timone for at least 6 months
  • Doped sensibility superior to 50 % (estimated by the section III of the score UPDRS)
  • Efficiency of the stimulation superior to 30 % (estimated by the section III of the score UPDRS)

You may not qualify if:

  • Absence of data concerning the location of electrodes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HM Timone

Marseille, Bouches Du Rhone, 13005, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • jean philippe AZULAY, MD

    AP-HM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2008

First Posted

May 23, 2008

Study Start

February 1, 2008

Primary Completion

February 1, 2010

Study Completion

December 1, 2010

Last Updated

August 28, 2014

Record last verified: 2014-08

Locations