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

NCT06791902 | Recruiting DMC FDA Device

• 1 other identifier: AdapGAIT
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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

Parkinson Disease

Keywords

walking deficits; DBS; Parkinson; gait problems; Deep Brain Stimulation; adaptive DBS; aDBS

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Occurrence of adverse events and serious adverse events that are deemed related or possibly related to the study procedures, or the use of the investigational system during the duration of the study

  Through study completion, a maximum of 5 weeks

Secondary Outcomes (6)

• Gait performance

  At Phase 1 (Day1) and Phase 2 (2 to 3 days within a maximum of 5 weeks from Day1) of the study.

• Freezing of Gait occurances

  At Phase 1 (Day1) and Phase 2 (2 to 3 days within a maximum of 5 weeks from Day1) of the study.

• Global Parkinsonian State

  At Phase 1 (Day1) and Phase 2 (2 to 3 days within a maximum of 5 weeks from Day1) of the study.

• Changes in neural patterns

  At Phase 1 (Day1) and Phase 2 (2 to 3 days within a maximum of 5 weeks from Day1) of the study.

• Sustained efficacy of adaptive DBS during activities of daily life - kinematics parameters

  At Phase 2, during the last day of the study (2nd or 3rd day of Phase 2 within a maximum of 5 weeks from Day1 of Phase 1).

Study Arms (1)

Adaptive DBS

EXPERIMENTAL

Device: Adaptive DBS

Interventions

Adaptive DBS DEVICE

Adapting DBS stimulation based on locomotor states to alleviate gait deficits

Adaptive DBS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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;
• 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

Sponsors & Collaborators

• Jocelyne Bloch: lead

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Mobility Limitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jocelyne Bloch, Prof. MD

CONTACT

+41 79 556 2951; jocelyne.bloch@chuv.ch

Eduardo Martin Moraud, Prof.

CONTACT

+41213142455; Eduardo.Martin-Moraud@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 24, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)