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NCT06791902Recruiting

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

Source: ClinicalTrials.gov · Last updated 17 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
10 (estimated)
First submitted
9 Jan 2025
Start date
1 Jan 2025
Primary completion date
1 Jan 2027
Lead sponsor
Jocelyne Bloch
NCT number
NCT06791902

What you commit to

  • Study type: Interventional
  • Planned participants: 10
  • From 1 Jan 2025 to the primary completion date, 1 Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of major psychiatric disorders or major neurocognitive disorders, as considered by the investigators in according with treating physicians;
  • History of drug or alcohol abuse in the past 5 years;

Other

  • 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;
  • Major changes in PD treatments planned within the course of the study;
  • Pregnancy;
  • Participation in another investigational study in the preceding 30 days or during the study

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHUV
Coordinator of this site? Confirm its status
LausanneSwitzerlandRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.