Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT01682668

Subthalamic Nucleus, Akinesia and Parkinson's Disease

Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2024-11-27

180

Participants Needed

2

Research Sites

652 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 .

CONDITIONS

Official Title

Subthalamic Nucleus, Akinesia and Parkinson's Disease

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of idiopathic Parkinson's disease according to United Kingdom Parkinson's Disease Society Brain Bank criteria
  • Age between 18 and 70 years
  • Motor complications with motor fluctuations or dyskinesias despite optimal dopaminergic treatment (for operated patients)
  • Stable medical conditions not interfering with the study
  • Excellent response to levodopa (more than 50% improvement in UPDRS motor score)
  • Brain MRI without abnormalities
  • Normal biological examination results
  • Voluntary informed consent with signed written consent
  • Patient with social health insurance
  • Presence of axial signs not improved by treatment (for non-operated patients)
  • Bilateral deep brain stimulation of the STN for more than 1 year (for already operated patients)
  • Normal neurological examination (for healthy subjects)
Not Eligible

You will not qualify if you...

  • Contraindications to necessary examinations
  • Progressive or worsening psychiatric disorders
  • Dementia with Mini-Mental State Examination score less than 24/30
  • Medical conditions making surgery dangerous (for surgical patients)
  • Bleeding disorders or abnormal clotting test results
  • Contraindications to MRI such as pacemakers, ferromagnetic implants, intraocular foreign bodies, pregnancy, or claustrophobia
  • Taking drugs interfering with coagulation within 1 month before surgery
  • Persons under guardianship, curatorship, or legal deprivation of rights
  • Neurological, orthopedic, or psychiatric history (for healthy subjects)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

CIC-GHPS

Paris, France, 75013

Actively Recruiting

2

Groupe Hospitalier Pitie-Salpêtrière

Paris, France, 75013

Actively Recruiting

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Research Team

M

Marie-Laure Welter, MD, PhD

CONTACT

C

Carine Karachi, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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Subthalamic Nucleus, Akinesia and Parkinson's Disease | DecenTrialz