Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT06791902
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06791902
Study Brief:
Protocol Section:
NCT06791902