Parkinson's Disease Trial, Recruiting NCT05626608 Sponsor: University Hospital, Montpellier Condition: Parkinson's Disease
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Parkinson's Disease Trial, Recruiting

NCT05626608
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:

  • People who have been diagnosed with bilateral idiopathic Parkinson's disease (Parkinson's affecting both sides of the body, with no known cause) based on specific medical criteria that include slowness of movement and muscle stiffness or tremor at rest
  • People whose Parkinson's disease has been developing for more than 4 years
  • People whose symptoms respond well to the medication L-Dopa, with at least a 30% improvement in motor symptoms measured on a standard rating scale (tremor is an exception to this requirement)
  • People whose Parkinson's motor symptoms score above a certain level on a standard medical rating scale when not taking medication
  • People whose tremor is not well controlled by current medication and makes up the main part of their symptoms, and whose treatment has remained stable
  • People who experience major movement fluctuations, including prolonged periods of reduced mobility and/or uncontrolled involuntary movements (dyskinesias)
  • People who are considered suitable candidates for a specific type of brain surgery involving electrode implants placed on both sides of the brain in an area called the STN
  • People whose disease severity, measured on a standard scale, is at or below a certain level when taking their best medication
  • People whose ability to carry out daily activities is affected beyond a certain level, as measured by a standard rating scale
  • People who do not have other health conditions that would prevent them from safely undergoing general anaesthesia, brain surgery, or completing the follow-up required by the study

Who may not be able to join:

  • People currently experiencing a significant depressive episode, as measured by a standard depression scale (note: past depressive episodes that have fully resolved before joining may not be a barrier — confirm with trial site)
  • People who have had or are currently experiencing psychotic episodes such as hallucinations (mild or brief episodes that fully resolved before joining may not be a barrier — confirm with trial site)
  • People showing signs of dementia, based on a standard memory and thinking assessment
  • People for whom general anaesthesia is not medically safe
  • People who cannot have an MRI scan due to having certain implanted devices, such as a pacemaker, cochlear implant, implantable defibrillator, or neurosensory stimulator, or who have certain metal fragments near nerve structures in the eye or brain
  • People for whom MRI may carry additional risks, such as those with metal dental braces or other metal prostheses, those who have difficulty staying still, pregnant women, people with certain types of brain shunts, or people with tattoos containing iron particles (confirm with trial site for individual assessment)
  • People whose brain MRI shows certain abnormalities, such as stroke damage, abnormal blood vessels, or significant brain shrinkage
  • People with serious ongoing illness unrelated to Parkinson's disease
  • People for whom surgery is not considered safe
  • Women who are pregnant, planning to become pregnant during the study, currently breastfeeding, or who are able to become pregnant and are not using effective contraception
  • People who are unable or unwilling to attend regular follow-up appointments for at least 30 months
  • People who are currently taking part in another interventional research study
  • People who are legally protected or under a form of legal guardianship
  • People who are unable to operate the device's remote control and charging system on their own and do not have someone available to assist them
  • People who have not provided written consent after being given adequate time to consider participation
  • People who are not affiliated with or covered by the French social security system

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 26 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.

Contact this trial

Principal Investigator: Gaëtan POULEN, PD, CHU de Montpellier

Phone: 0467337262

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
28 April 2023
Est. completion
28 October 2026

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Comparison of motor scores

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: 26 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