NCT01682668

Brief Summary

This program aims to understand the role of the subthalamic nucleus in the control of the movement in healthy humans and patients with Parkinson's disease, how the STN dysfunction contributes to akinesia and how the STN stimulation improves motor signs in PD patients .

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

First Submitted

Initial submission to the registry

July 19, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

12.3 years

First QC Date

July 19, 2012

Last Update Submit

November 25, 2024

Conditions

Parkinson's Disease

Keywords

parkinson's diseasesubthalamic nucleusakinesiagait initiationneuronal activitybefore STN stimulationwith STN stimulationfunctional MRI

Outcome Measures

Primary Outcomes (1)

  • Firing rate of the subthalamic neurons

    Changes in the neuronal activity of the STN before, during and after the execution of an arm movement

    During surgery for bilateral STN stimulation

Secondary Outcomes (2)

  • Evoked related potentials of the STN

    3-5 days after surgery for bilateral STN stimulation

  • Biomechanical parameters of gait initiation

    6 months

Other Outcomes (2)

  • BOLD signal during fMRI

    1 month before surgery

  • real-life assessment

    1 month after surgery

Study Arms (1)

Frequency of subthalamic stimulation

EXPERIMENTAL

Comparison between healthy controls and PD patients (non-operable patients or who will be operated or already operated)

Procedure: Bilateral subthalamic stimulation

Interventions

Bilateral subthalamic stimulationPROCEDURE
Frequency of subthalamic stimulation

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank)
  • Age between 18 and 70;
  • Motor complications in the form of fluctuations in motor state or dyskinesias induced by dopaminergic therapy, despite medical treatment optimum;
  • Other medical conditions that are stable or do not interfere with the procedure proposed;
  • Excellent responsiveness to levodopa (UPDRS motor score improvement greater than 50% in the acute levodopa test)
  • Brain MRI without abnormality
  • Normality of biological examinations
  • Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent)
  • Patient with social health insurance
  • Evolutionary psychiatric pathology;
  • Dementia(MMS\<24/30);
  • Patients with a medical condition that makes surgery dangerous neuro-surgical;
  • Bleeding-promoting diseases and laboratory test abnormalities clotting;
  • Existence of contraindications to MRI (cardiac or neural pacemaker, clips ferromagnetic surgeries, implants and metal objects, foreign bodies intraocular, pregnancy, claustrophobia).
  • Taking drugs interfering with coagulation for 1 month before intervention.
  • +29 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CIC-GHPS

Paris, 75013, France

RECRUITING

Groupe Hospitalier Pitie-Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Marie-Laure Welter, MD, PhD

    GHPS, APHP, Paris, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Laure Welter, MD, PhD

CONTACT

marielaure.welter@icm-institute.org

Carine Karachi, MD, PhD

CONTACT

carine.karachi@gmail.com

Study Design

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

Study Record Dates

First Submitted

July 19, 2012

First Posted

September 11, 2012

Study Start

February 1, 2013

Primary Completion

May 1, 2025

Study Completion

August 1, 2025

Last Updated

November 27, 2024

Record last verified: 2024-11

Locations

FR(2)