NCT06791902 Study on Preliminary Safety and Efficacy of Adaptive DBS Aligned to Locomotor States to Improve Locomotor Functions in Parkinson's Patients
| NCT ID | NCT06791902 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jocelyne Bloch |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-01-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
At present, there is no cure for Parkinson's disease. The standard treatment involves taking dopaminergic drugs. When drugs lose their effectiveness, they can be supplemented by Deep Brain Stimulation (DBS) therapy. Medication and deep brain stimulation are effective for motor problems such as tremors, slowness of movement, and muscle stiffness. However, there is no effective treatment for walking and balance problems that occur during the course of the disease. DBS neurostimulators not only stimulate, but also record brain activity in the region in which the electrodes are implanted. This brain activity changes over time, depending on the individual's general state (i.e., medication, eating), movements (sitting, standing or walking) and motor problems (i.e., problems of gait initiation and termination, balance problems and freezing of gait). Adaptive deep brain stimulation (aDBS) makes it possible to change the stimulation according to brain activity, and thus to these different states. This method involves using the usual Medtronic Percept neurostimulator with its adaptive therapy active. Additional investigational features for adaptive therapy are available within the study. In this study, we want to evaluate whether adaptive deep brain stimulation is safe and effective in improving walking problems in people with Parkinson's disease.
Eligibility Criteria
Inclusion Criteria: * Diagnosed with typical or atypical forms of Parkinson's disease; Suffering from gait or balance disorders; * Implanted with a full Medtronic Percept suite (neurostimulator Percept PC Model B35200 or Percept RC Model B35300; with bilateral leads (Medtronic Legacy leads (Models 3387 and 3389) or Medtronic SenSightTM Directional Lead (models B33015 and B33005)) and lead extensions (Medtronic extensions (Model 37085 and 37086) or SenSightTM extension (model B34000)), or Medtronic SenSightTM Connector Plug (Model B31061)); * Exhibit modulations in at least one frequency band of the LFP that are related to locomotor states or gait deficits. * Aged 18 years-old or more; * Must provide and sign the study's Informed Consent prior to any study-related procedures; * Able to understand and interact with the study team in French; * Agree to comply in good faith with all conditions of the recordings, and to attend all required study procedures Exclusion Criteria: * Exclusive use of interleaved DBS programs that are incompatible with aDBS; * High impedances or artefacts in neural signals that obstruct the detection of motor-related biomarkers for adaptive DBS; * Changes in DBS amplitudes (increase/decrease) not well tolerated; * Secondary causes of gait problems independent of PD; * Inability to follow the procedures of the study independently; * History of major psychiatric disorders or major neurocognitive disorders, as considered by the investigators in according with treating physicians; * Major changes in PD treatments planned within the course of the study; * History of drug or alcohol abuse in the past 5 years; * Pregnancy; * Participation in another investigational study in the preceding 30 days or during the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06791902 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06791902 currently recruiting?
Yes, NCT06791902 is actively recruiting participants. Contact the research team at jocelyne.bloch@chuv.ch for enrollment information.
Where is the NCT06791902 trial being conducted?
This trial is being conducted at Lausanne, Switzerland.
Who is sponsoring the NCT06791902 clinical trial?
NCT06791902 is sponsored by Jocelyne Bloch. The trial plans to enroll 10 participants.
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