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New directional brain stimulation aims to stop Parkinson's freezing

NCT ID NCT04223427

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether directional deep brain stimulation (DBS) can improve walking and balance problems in people with Parkinson's disease. Nineteen patients who already had DBS electrodes implanted took part. Researchers compared different stimulation settings to see which helped reduce freezing of gait.

What this could mean

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

Active substance
directional deep brain stimulation (DBS) electrode
What this could lead to
If it works, this could help doctors fine-tune DBS to reduce freezing of gait and falls in Parkinson's patients.
What could go wrong
This is a small pilot study with only 19 people, so results may not apply to everyone. The effect on gait varies from person to person.

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

19 people

The number who actually took part.

Started

Jan 2020

Finished

Jul 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: 1. Age between 18 and 70 years 2. Diagnosis of Parkinson's Disease; as defined by the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) criteria 3. Patients eligible for subthalamic bilateral deep brain stimulation (STN-DBS) according to local inclusion criteria; 4. Freezing of gait in the OFF-dopa condition with item 2.13 of the MDS-UPDRS \> 0 in usual life; 5. Patient having read and understood the information letter and signed the Informed Consent Form 6. Patient affiliated with, or beneficiary of a social security category 7. Stability of others medical disorders or that do not interfere with the research protocol. 8. Woman of childbearing potential with effective contraception according to WHO definition (estrogen-progestin or intra-uterine device or tubal ligation) since at least 3 months (negative urinary pregnancy test at inclusion) Exclusion Criteria: 1. Actual and severe psychiatric pathology or other neurological disorder 2. Dementia (MMS \<24/30) 3. Contraindication to research MRI (without contrast product) such as claustrophobia, metallic splinters in the eyes, ferromagnetic foreign bodies close to nerve structures, cardiac, ORL and neurological devices not MRI compatible, wearing of osteosynthseis equipment prior to 1980, metal prostheses, bypass valves ventriculoperitoneal neurosurgery, tattoos containing iron particles… 4. Contraindication to surgery: hemostasis trouble, anticoagulants or antiagregants treatment, ongoing infection 5. Hypersensitivity to contrasts agents 6. Persons under guardianship, tutorship or any other administrative or judicial measure of deprivation of rights and liberty 7. Subject at the time of exclusion from other biomedical research or participating in any other biomedical research or therapeutic trial 8. Pregnant or parturient or lactating woman or lack of proven and effective contraception according to WHO definition (estrogen-progestin or intra-uterine device or tubal ligation) (for women of childbearing age)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • CHU de ROUEN

    Rouen, France, 76000, France

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