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New brain surgery technique for Parkinson's could be just as effective without keeping patients awake

NCT ID NCT04884412

Disease control Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new way to place deep brain stimulation electrodes in people with Parkinson's disease. Instead of the usual method that requires patients to be awake for testing, the new approach uses MRI scans and a computer model to guide the surgery under general anesthesia. The trial involved 128 adults with advanced Parkinson's and compared motor improvement one year after surgery between the two methods.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Deep brain stimulation surgery with a new MRI-based targeting method (PARKEO_2) under general anesthesia, without micro-electrode recordings
What this could lead to
If successful, this could make deep brain stimulation surgery more comfortable and consistent for Parkinson's patients by avoiding awake testing and reducing variability between centers.
What could go wrong
This is a completed trial with 128 participants, but the new method may not be as effective as the standard procedure, and results may not apply to all patients or centers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

128 people

The number who actually took part.

Started

Nov 2021

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with a diagnosis of idiopathic Parkinson's disease at the stage of motor fluctuations despite optimal medical treatment * L-DOPA sensitivity defined by motor improvement above 50% on the UPDRS-3 scale after a dose of 150% of the usual early morning treatment * Indication for STN-DBS approved by the local multidisciplinary movement disorders committee. * Patients between 18 and 70 years of age * Patients covered by a health insurance scheme * Signed informed consent. Exclusion Criteria: * Significant cognitive decline defined as a score \< 22 on the MoCA scale * Mood disorders defined by a score \> 20 on the Beck Depression Inventory * Significant cortical atrophy or leukoencephalopathy visualised by brain MRI * Contraindication to anaesthesia and MRI * Lack of contraceptive treatment for women with ability to procreate * Pregnant or breast-feeding woman * Unstoppable anticoagulant or antiaggregant treatment * Persons under legal protection (Persons deprived of liberty or incapable of giving consent or under curatorship or tutorship…) * Patient with severe psychiatric disorders (on Diagnostic and Statistical Manual of Mental Disorders IV) * Inability to follow the patient until the end of study

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson disease

Contacts and locations

Locations

  • CHU Amiens

    Amiens, France

  • CHU Marseille

    Marseille, 13005, France

  • CHU de Bordeaux

    Bordeaux, France

  • CHU de Nice

    Nice, France

  • CHU de Rouen

    Rouen, France

  • CHU de Strasbourg

    Strasbourg, France

  • CHU de Toulouse

    Toulouse, France

  • Hospices Civils de Lyon

    Lyon, France

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