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

Inclusion Criteria:

• 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

Exclusion Criteria:

• DBS (hardware or programs) incompatible with BrainSense recordings, such as use of interleaved DBS programs or pocket adaptors;
• 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