Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06791902

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

Led by Jocelyne Bloch · Updated on 2025-12-17

10

Participants Needed

1

Research Sites

104 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with typical or atypical forms of Parkinson's disease with gait or balance disorders
  • Implanted with a full Medtronic Percept neurostimulator system including specific bilateral leads and extensions
  • Show brain activity modulations related to locomotor states or gait deficits
  • Aged 18 years or older
  • Able to provide and sign informed consent before study procedures
  • Able to understand and communicate in French
  • Willing to comply with all study recording conditions and attend all required procedures
Not Eligible

You will not qualify if you...

  • Use of interleaved DBS programs incompatible with adaptive DBS
  • Presence of high impedances or artifacts in neural signals blocking detection of motor-related biomarkers
  • Poor tolerance to changes in DBS amplitude
  • Gait problems from causes other than Parkinson's disease
  • Inability to follow study procedures independently
  • History of major psychiatric or neurocognitive disorders as judged by investigators
  • Planned major changes in Parkinson's treatments during the study
  • History of drug or alcohol abuse in the past 5 years
  • Pregnancy
  • Participation in another investigational study within 30 days before or during this study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHUV

Lausanne, Canton of Vaud, Switzerland, 1011

Actively Recruiting

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Research Team

J

Jocelyne Bloch, Prof. MD

CONTACT

E

Eduardo Martin Moraud, Prof.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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