Parkinson's Disease Trial, Recruiting NCT01682668 Sponsor: Institut National de la Santé Et de la Recherche Médicale, France Condition: Parkinson's Disease
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Parkinson's Disease Trial, Recruiting

NCT01682668
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

This trial has four different groups of participants. Depending on which group applies, the relevant criteria are listed below.

Group 1 – People with Parkinson's disease who are planning to have surgery:

  • A confirmed diagnosis of idiopathic (no known cause) Parkinson's disease, based on a specific set of standard diagnostic guidelines
  • Aged between 18 and 70 years old
  • Experiencing movement problems such as fluctuations in movement ability or involuntary movements (dyskinesias) caused by Parkinson's medication, even after trying the best available medication options
  • Any other health conditions that are stable and do not interfere with the planned procedure
  • A very strong positive response to levodopa medication, shown by a specific movement test (confirm with trial site)
  • A brain MRI scan showing no abnormalities
  • Normal results on standard blood and laboratory tests
  • Willingness to take part, confirmed by signing a written consent form
  • Enrolled in social health insurance

Group 2 – People with Parkinson's disease who are not having surgery:

  • A confirmed diagnosis of idiopathic Parkinson's disease, based on standard diagnostic guidelines
  • Aged between 18 and 70 years old
  • Any other health conditions that are stable and do not interfere with the study
  • Experiencing walking and/or balance difficulties that do not improve with Parkinson's medication
  • A brain MRI scan showing no notable abnormalities
  • Normal results on standard blood and laboratory tests
  • Willingness to take part, confirmed by signing a written consent form
  • Enrolled in social health insurance

Group 3 – People with Parkinson's disease who have already had surgery:

  • A confirmed diagnosis of idiopathic Parkinson's disease, based on standard diagnostic guidelines
  • Already having had deep brain stimulation surgery on both sides of a specific brain region (the subthalamic nucleus) more than one year ago
  • Aged between 18 and 70 years old
  • Willingness to take part, confirmed by signing a written consent form
  • Enrolled in social health insurance

Group 4 – Healthy volunteers:

  • Aged between 18 and 70 years old
  • A normal neurological examination
  • Willingness to take part, confirmed by signing a written consent form
  • Enrolled in social health insurance

Who may not be able to join:

Group 1 – People with Parkinson's disease planning surgery:

  • Any condition that prevents the person from completing the tests required for the study
  • An active or progressing psychiatric condition
  • Signs of dementia, based on a standard cognitive test score below a certain threshold (confirm with trial site)
  • A medical condition that would make brain surgery unsafe
  • A condition or test result that increases the risk of bleeding or affects blood clotting
  • Any reason that makes having an MRI scan unsafe, such as having a pacemaker, certain metal implants or clips in the body, metal foreign objects in the eyes, being pregnant, or experiencing claustrophobia
  • Having taken medications that affect blood clotting within one month before the planned surgery
  • Being under legal guardianship or any court or administrative order that restricts personal rights and freedoms

Group 2 – People with Parkinson's disease not having surgery:

  • Any condition that prevents the person from completing the tests required for the study
  • An active or progressing psychiatric condition
  • Signs of dementia, based on a standard cognitive test score below a certain threshold (confirm with trial site)
  • Any reason that makes having an MRI scan unsafe, such as having a pacemaker, certain metal implants or clips in the body, metal foreign objects in the eyes, being pregnant, or experiencing claustrophobia
  • Being under legal guardianship or any court or administrative order that restricts personal rights and freedoms

Group 3 – People with Parkinson's disease who have already had surgery:

  • Any condition that prevents the person from completing the tests required for the study
  • An active or progressing psychiatric condition
  • Signs of dementia, based on a standard cognitive test score below a certain threshold (confirm with trial site)
  • Being under legal guardianship or any court or administrative order that restricts personal rights and freedoms

Group 4 – Healthy volunteers:

  • Being under legal guardianship or any court or administrative order that restricts personal rights and freedoms
  • A history of neurological, orthopaedic, or psychiatric conditions
  • Any reason that makes having an MRI scan unsafe, such as having a pacemaker, certain metal implants or clips in the body, metal foreign objects in the eyes, being pregnant, or experiencing claustrophobia

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Registry
ClinicalTrials.gov
Start date
1 February 2013
Est. completion
1 July 2026

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Firing rate of the subthalamic neurons

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov