Study on Preliminary Safety and Efficacy of Adaptive DBS Aligned to Locomotor States to Improve Locomotor Functions in Parkinson's Patients

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 the 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 your general state (i.e., medication, eating), your movements (sitting, standing or walking) and your 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 by activating this adaptive function. 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosed with typical or atypical forms of Parkinson's disease; Suffering from gait or balance disorders;

• Implanted with a full Medtronic Percept PC suite (neurostimulator Percept PC B35200; 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

Locations
Other Locations
Switzerland
CHUV
RECRUITING
Lausanne
Contact Information
Primary
Jocelyne Bloch, Prof. MD
jocelyne.bloch@chuv.ch
+41 79 556 2951
Backup
Eduardo Martin Moraud, Prof.
Eduardo.Martin-Moraud@chuv.ch
+41213142455
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 10
Treatments
Experimental: Adaptive DBS
Sponsors
Leads: Jocelyne Bloch

This content was sourced from clinicaltrials.gov