Parkinson's DiseaseGAITPARKNCT02931097
DBS of the MLR for Gait and Balance Disorders in PD Patients
A study testing Deep brain stimulation in people with Parkinson's Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Gait and balance disorders represent the main motor disability in advanced Parkinson's disease. These symptoms are less or unresponsive to levodopa treatment and are considered to be a contraindication for deep brain stimulation of the subthalamic nucleus. Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age below 71 years
- severe form of Parkinson's Disease with disease duration > 5 years
- presence of gait and/or balance disorders unresponsive to levodopa treatment,
- > 40% decrease in others motor symptoms with levodopa treatment
- health insurance
- give signed informed written consent
Who cannot join
- dementia (Mattis Dementia Rating Scale < 129, MDRS),
- ongoing psychiatric disturbances,
- surgical contraindications
- significant brain lesions detected on MRI.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Investigation Clinique-Institut du Cerveau et de la Moelle Epiniere
Paris, 75013
About this study
Official title: Effects of Deep Brain Stimulation of the Mesencephalic Locomotor Region on Gait and Balance Disorders in Parkinson's Disease Patients : a Randomized, Double-blind, Cross-over Study
Gait and balance disorders represent the main motor disability in advanced Parkinson's disease. These symptoms are less or unresponsive to levodopa treatment and are considered to be a contraindication for deep brain stimulation of the subthalamic nucleus. Falls and freezing of gait are responsible for high morbidity (fractures, residential health care) and increased significantly mortality. The pathophysiology of gait and balance disorders is still poorly understood, but recent data obtained in animals and humans suggest that a degeneration of cholinergic neurons of the pedunculopontine nucleus (PPN), within the mesencephalic locomotor region, could play a crucial role. In line with this hypothesis, low-frequency stimulation of the pedunculopontine area, thought to increase the activity of the remaining cholinergic PPN neurons, has been proposed to alleviate gait and balance disorders in advanced PD patients. Here, the efficacy of deep brain stimulation of the mesencephalic locomotor region will be tested in 12 PD patients in a randomized, double-blind, cross-over, controlled study.
- Conditions
- Parkinson's Disease
- Being tested
- Deep brain stimulation, Sham stimulation
- Keywords
- Parkinson's disease, Deep brain stimulation, Mesencephalic locomotor region
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationDevice
Stimulating deep brain electrodes and pulse generator
Sham stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Pedunculopontine stimulation | Active comparator | Deep brain stimulation of the pedunculopontine area Receives: Device: Deep brain stimulation |
| Pontomesencephalic stimulation | Active comparator | Deep brain stimulation of the pontomesencephalic area Receives: Device: Deep brain stimulation |
| Sham stimulation | Sham comparator | No deep brain stimulation Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the anticipatory postural adjustments between each deep brain stimulation condition
Measured: 3, 5, 7 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2019
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Marie-Laure Welter, MD, PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931097
- Sponsor's protocol ID
- C15-46
- Other IDs
- 2016-A00792-49
- Acronym
- GAITPARK
- Status last verified
- Jan 2021
- First submitted
- 7 Oct 2016
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bourilhon J, Olivier C, You H, Collomb-Clerc A, Grabli D, Belaid H, Mullie Y, Francois C, Czernecki V, Lau B, Perez-Garcia F, Bardinet E, Fernandez-Vidal S, Karachi C, Welter ML. Pedunculopontine and Cuneiform Nuclei Deep Brain Stimulation for Severe Gait and Balance Disorders in Parkinson's Disease: Interim Results from a Randomized Double-Blind Clinical Trial. J Parkinsons Dis. 2022;12(2):639-653. doi: 10.3233/JPD-212793.
PubMed 34744048Bourilhon J, Mullie Y, Olivier C, Cherif S, Belaid H, Grabli D, Czernecki V, Karachi C, Welter ML. Stimulation of the pedunculopontine and cuneiform nuclei for freezing of gait and falls in Parkinson disease: Cross-over single-blinded study and long-term follow-up. Parkinsonism Relat Disord. 2022 Mar;96:13-17. doi: 10.1016/j.parkreldis.2022.01.010. Epub 2022 Jan 22.
PubMed 35121249
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Deep Brain Stimulation of the Mesencephalic Locomotor Region on Gait and Balance Disorders in Parkinson's Disease Patients : a Randomized, Double-blind, Cross-over Study
- ClinicalTrials.gov ID
- NCT02931097
- Acronym / sponsor ID
- GAITPARK / C15-46
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Deep brain stimulation, Mesencephalic locomotor region
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Oct 2016 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 12 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gait and balance disorders represent the main motor disability in advanced Parkinson's disease. These symptoms are less or unresponsive to levodopa treatment and are considered to be a contraindication for deep brain stimulation of the subthalamic nucleus. Falls and freezing of gait are responsible for high morbidity (fractures, residential health care) and increased significantly mortality. The pathophysiology of gait and balance disorders is still poorly understood, but recent data obtained in animals and humans suggest that a degeneration of cholinergic neurons of the pedunculopontine nucleus (PPN), within the mesencephalic locomotor region, could play a crucial role. In line with this hypothesis, low-frequency stimulation of the pedunculopontine area, thought to increase the activity of the remaining cholinergic PPN neurons, has been proposed to alleviate gait and balance disorders in advanced PD patients. Here, the efficacy of deep brain stimulation of the mesencephalic locomotor region will be tested in 12 PD patients in a randomized, double-blind, cross-over, controlled study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pedunculopontine stimulation | Active comparator | Device: Deep brain stimulationDeep brain stimulation of the pedunculopontine area |
| Pontomesencephalic stimulation | Active comparator | Device: Deep brain stimulationDeep brain stimulation of the pontomesencephalic area |
| Sham stimulation | Sham comparator | Device: Sham stimulationNo deep brain stimulation |
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age below 71 years
- severe form of Parkinson's Disease with disease duration > 5 years
- presence of gait and/or balance disorders unresponsive to levodopa treatment,
- > 40% decrease in others motor symptoms with levodopa treatment
- health insurance
Key exclusion criteria (4 listed)
- dementia (Mattis Dementia Rating Scale < 129, MDRS),
- ongoing psychiatric disturbances,
- surgical contraindications
- significant brain lesions detected on MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep brain stimulationStimulating deep brain electrodes and pulse generator | Device | Pedunculopontine stimulation, Pontomesencephalic stimulation |
| Sham stimulation | Device | Sham stimulation |
Primary outcome
Change in the anticipatory postural adjustments between each deep brain stimulation condition
Time frame: 3, 5, 7 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Results publication: PubMed 34744048Bourilhon J, Olivier C, You H, Collomb-Clerc A, Grabli D, Belaid H, Mullie Y, Francois C, Czernecki V, Lau B, Perez-Garcia F, Bardinet E, Fernandez-Vidal S, Karachi C, Welter ML. Pedunculopontine and Cuneiform Nuclei Deep Brain Stimulation for Severe Gait and Balance Disorders in Parkinson's Disease: Interim Results from a Randomized Double-Blind Clinical Trial. J Parkinsons Dis. 2022;12(2):639-653. doi: 10.3233/JPD-212793.
- Results publication: PubMed 35121249Bourilhon J, Mullie Y, Olivier C, Cherif S, Belaid H, Grabli D, Czernecki V, Karachi C, Welter ML. Stimulation of the pedunculopontine and cuneiform nuclei for freezing of gait and falls in Parkinson disease: Cross-over single-blinded study and long-term follow-up. Parkinsonism Relat Disord. 2022 Mar;96:13-17. doi: 10.1016/j.parkreldis.2022.01.010. Epub 2022 Jan 22.
- Individual participant dataSharing planned: No
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Laure Welter, MD, PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation in people with Parkinson's Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the anticipatory postural adjustments between each deep brain stimulation condition (time frame: 3, 5, 7 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02931097, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.