Improving walking functions in Parkinson's patients using adaptive deep brain stimulation

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

This study is testing if a new brain stimulation technique can help people with Parkinson's disease walk better and more safely by adjusting the treatment based on their movement.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire Vaudois (other)
• Locations: 1 site (Lausanne, Canton of Vaud)
• Trial ID: NCT06791902 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and efficacy of adaptive deep brain stimulation (aDBS) tailored to locomotor states in patients with Parkinson's disease. It aims to enhance gait initiation, termination, and overall walking stability by adjusting stimulation based on real-time brain activity. The study is structured into three sessions over a month, focusing on eligibility assessment, acute effects of aDBS, and sustained effects in daily life. Participants will be monitored for their response to the stimulation and its impact on their mobility.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with Parkinson's disease who experience gait or balance disorders and have compatible deep brain stimulation hardware.

Not a fit: Patients who do not have the required DBS hardware or those with incompatible conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve walking and balance in Parkinson's patients, enhancing their quality of life.

How similar studies have performed: While adaptive deep brain stimulation is a novel approach, preliminary studies have shown promise in similar applications for other motor deficits.

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

Where this trial is running

Lausanne, Canton of Vaud

• CHUV — Lausanne, Canton of Vaud, Switzerland (RECRUITING)

Study contacts

• Study coordinator: Jocelyne Bloch, Prof. MD

Conditions: Parkinson Disease, walking deficits, DBS, Parkinson, gait problems, Deep Brain Stimulation, adaptive DBS, aDBS