Parkinson's DiseaseGB-MOVNCT01682668
Subthalamic Nucleus, Akinesia and Parkinson's Disease
A study testing Bilateral subthalamic stimulation in people with Parkinson's Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in France.
Trial summary
This program aims to understand the role of the subthalamic nucleus in the control of the movement in healthy humans and patients with Parkinson's disease, how the STN dysfunction contributes to akinesia and how the STN stimulation improves motor signs in PD patients . Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Bilateral subthalamic stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2013to Aug 2026
- Phase
- Interventional
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank)
- Age between 18 and 70;
- Motor complications in the form of fluctuations in motor state or dyskinesias induced by dopaminergic therapy, despite medical treatment optimum;
- Other medical conditions that are stable or do not interfere with the procedure proposed;
- Excellent responsiveness to levodopa (UPDRS motor score improvement greater than 50% in the acute levodopa test)
- Brain MRI without abnormality
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- Normality of biological examinations
- Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent)
- Patient with social health insurance
- Criteria for non-inclusion of Parkinsonian patients who will be operated
- Contraindication to examinations necessary for inclusion
- Evolutionary psychiatric pathology;
- Dementia(MMS<24/30);
- Patients with a medical condition that makes surgery dangerous neuro-surgical;
- Bleeding-promoting diseases and laboratory test abnormalities clotting;
- Existence of contraindications to MRI (cardiac or neural pacemaker, clips ferromagnetic surgeries, implants and metal objects, foreign bodies intraocular, pregnancy, claustrophobia).
- Taking drugs interfering with coagulation for 1 month before intervention.
- Persons under guardianship, curatorship or any other administrative or judicial measure deprivation of rights and liberty
- Selection criteria for non-operated patients
- Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank);
- Age between 18 and 70;
- Other medical conditions that are stable or do not interfere with the proposed protocol;
- Presence of axial signs (gait and/or balance disorders) no improved by antiparkinsonian treatment
- Brain MRI without notable abnormality
- Normality of biological examinations
- Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent)
- Patient with social health insurance
- Criteria for non-inclusion of non-operated patients
- Contraindication to examinations necessary for inclusion
- Progressive psychiatric pathology;
- Dementia (MMS<24/30);
- Existence of contraindications to MRI (cardiac or neural pacemaker, clips ferromagnetic surgeries, implants and metal objects, foreign bodies intraocular, pregnancy, claustrophobia).
- Persons under guardianship, curatorship or any other administrative or judicial measuredeprivation of rights and liberty
- Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank);
- Bilateral deep brain stimulation of the subthalamic nucleus for more than 1 year
- Age between 18 and 70;
- Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent)
- Patient with social health insurance
- Criteria for non-inclusion of Parkinsonian patients (already operated)
- Contraindication to examinations necessary for inclusion
- Evolutionary psychiatric pathology;
- Dementia(MMS<24/30);
- Persons under guardianship, curatorship or any other administrative or judicial measure deprivation of rights and liberty
- Age between 18 and 70 years old
- Normal neurological examination
- Person who voluntarily and informedly agreed to participate in the study (signature of a written consent)
- Patient with social health insurance
- Criteria for non-inclusion of healthy subjects
- Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights and freedom
- Existence of neurological, orthopedic or psychiatric history
- Existence of contraindications to MRI (cardiac or neural pacemaker, ferromagnetic surgical clips, implants and metallic objects, foreign bodies intraocular, pregnancy, claustrophobia).
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Marie-Laure Welter, MD, PhD contact
Carine Karachi, MD, PhD contact
France2 sites, 2 recruiting
- Recruiting
Groupe Hospitalier Pitie-Salpêtrière
Paris, PARIS, 75013
Marie-Laure Welter, MD, PhD, marie-laure.welter@psl.aphp.fr
- Recruiting
CIC-GHPS
Paris, 75013
Marie-Laure WELTER, PH, 0142162461, marielaure.welter@icm-institute.org
About this study
Official title: Role of the Subthalamic Nucleus in the Control of Movement: Physiopathology of Akinesia in Parkinson's Disease.
This program aims to understand the role of the subthalamic nucleus in the control of the movement in healthy humans and patients with Parkinson's disease, how the STN dysfunction contributes to akinesia and how the STN stimulation improves motor signs in PD patients .
- Conditions
- Parkinson's Disease
- Being tested
- Bilateral subthalamic stimulation
- Keywords
- parkinson's disease, subthalamic nucleus, akinesia, gait initiation, neuronal activity, before STN stimulation, with STN stimulation, functional MRI
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral subthalamic stimulationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Frequency of subthalamic stimulation | Experimental | Comparison between healthy controls and PD patients (non-operable patients or who will be operated or already operated) Receives: Procedure: Bilateral subthalamic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Firing rate of the subthalamic neurons
Changes in the neuronal activity of the STN before, during and after the execution of an arm movement
Measured: During surgery for bilateral STN stimulation
Secondary outcomes (2)
Evoked related potentials of the STN
Local-field potentials recordings with DBS electrodes when performing the execution of an arm movement or gait initiation
Measured: 3-5 days after surgery for bilateral STN stimulation
Biomechanical parameters of gait initiation
Gait initiation parameters by using a forceplate and EMG recordings
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startFeb 2013
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Marie-Laure Welter, MD, PhD, Principal investigator, GHPS, APHP, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682668
- Sponsor's protocol ID
- C11-40
- Other IDs
- 2012-A00225-38
- Acronym
- GB-MOV
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2012
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No