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Tests treatment safety and results for Parkinson Disease
Official title Study on Preliminary Safety and Efficacy of Adaptive DBS Aligned to Locomotor States to Improve Locomotor Functions in Parkinson's Patients
ClinicalTrials.gov ID: NCT06791902
What this study is testing
- What it's testing
- At present, there is no cure for Parkinson's disease. The standard treatment involves taking dopaminergic drugs.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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;
You likely can't join if
- 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;
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lausanne, Canton of Vaud, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lausanne, Canton of Vaud, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.