Clinical trial NCT06791902: Study on Preliminary Safety and Efficacy of Adaptive DBS Aligned to Locomotor States to Improve Locomotor Functions in Parkinson's Patients
Official title: Study on Preliminary Safety and Efficacy of Adaptive DBS Aligned to Locomotor States to Improve Locomotor Functions in Parkinson's Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: walking deficits
DBS
Parkinson
gait problems
Deep Brain Stimulation
adaptive DBS
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 the 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 your general state (i.e., medication, eating), your movements (sitting, standing or walking) and your 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 by activating this adaptive function.

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.

Detailed description: The hypotheses of the current study are that:

HYPOTHESIS 1: Adaptive DBS, aligned in time to the occurrence of locomotor states, facilitates gait initiation, termination, turning, symmetry and adaptations to obstacles by titrating the delivery of stimulation to the dynamics of gait.

HYPOTHESIS 2: Enforcing that biomarkers of FoG never exceed an abnormally-high value prevents the occurrence of freezing of gait.

The resulting observations will establish a rigorous understanding of motor statedependent DBS modulations that will open new avenues for the design of evidence-based DBS strategies for locomotor deficits.

The study is divided into 3 different phases, which will take place on 3 different days at CHUV, and spread over maximum 1 month:

SESSION 1: Eligibility

* Evaluate Feasibility for aDBS
* Characterize Movement Modulations
* Assess Global Parkinsonian State

SESSION 2: Acute effects of aDBS

* Optimize aDBS Parameters
* Test Safety and Performance

SESSION 3: Sustained Effects in Everyday Life

* Evaluate Stability and Robustness
* Daily Life Use of aDBS

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 PC suite (neurostimulator Percept PC B35200; 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:

* DBS (hardware or programs) incompatible with BrainSense recordings, such as use of interleaved DBS programs or pocket adaptors;
* 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

Primary outcomes:
measure: Adverse events
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
measure: Gait performance
timeFrame: At Day 1, Day 2 (up to 1 month after Day 1) and Day 3 (24h after Day 2) of the study
measure: Freezing of Gait occurances
timeFrame: At Day 1, Day 2 (up to 1 month after Day 1) and Day 3 (24h after Day 2) of the study
measure: Global Parkinsonian State
timeFrame: At Day 1, Day 2 (up to 1 month after Day 1) and Day 3 (24h after Day 2) of the study
measure: Changes in neural patterns
timeFrame: At Day 2 (up to 1 month after Day 1) and Day 3 (24h after Day 2) of the study
measure: Sustained efficacy of adaptive DBS during activities of daily life - kinematics parameters
timeFrame: At Day 3 of the study
measure: Sustained efficacy of adaptive DBS during activities of daily life - questionnaire
timeFrame: At Day 3 of the study
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
state: Vaud
Study officials:
References: