Parkinson DiseaseAdapGAITNCT06791902
Study on Preliminary Safety and Efficacy of Adaptive DBS Aligned to Locomotor States to Improve Locomotor Functions in Parkinson's Patients
A study testing Adaptive DBS in people with Parkinson Disease, run by Jocelyne Bloch at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Adaptive DBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
CHUV
Lausanne, Canton of Vaud, 1011
Jocelyne Bloch, Prof. MD, +41 79 556 2951, neurorestore.studies@chuv.ch
About this study
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).
Read more
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.
Read the 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 state-dependent 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 will be spread over a maximum of 5 weeks:
PHASE 1: Eligibility (1 day at CHUV)
- Evaluate Feasibility for aDBS
- Characterize DBS and Movement Modulations
- Assess Global Parkinsonian State
PHASE 2: aDBS therapy setup and efficacy evaluation in different conditions (between 2 to 3 days at CHUV)
- Optimize aDBS Parameters
- Test Safety and Performance
- Evaluate Stability and Robustness
- Daily Life Use of aDBS
The 2 to 3 days of Phase 2 will happenoccur within 10 days.
- Conditions
- Parkinson Disease
- Being tested
- Adaptive DBS
- Keywords
- walking deficits, DBS, Parkinson, gait problems, Deep Brain Stimulation, adaptive DBS, aDBS
- Medical subject headings
- Parkinson Disease, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive DBSDevice
Adapting DBS stimulation based on locomotor states to alleviate gait deficits
| Study group | Role | What they receive |
|---|---|---|
| Adaptive DBS | Experimental | Not described Receives: Device: Adaptive DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, a maximum of 5 weeks
Secondary outcomes (6)
Gait performance
Timed up-and-go (TUG) task and 10m walk test are tests used to test used to assess gait speed and sit ro stand and gait ability. In the TUG cognitive the participant is also asked to perform a cognitive task when performing the motor task to see the gait ability during dual-task.
Measured: 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
- The 360° turn test is used to assess freezing during turn. It measures the time it takes to make a full turn on oneself and the number of steps.
- A custom-made freezing of gait (FOG) circuit is designed to assess the occurrence of freezing of gait. Participants are asked to perform tasks known to favour freezing of gait occurrence. Participants can use their habitual assistive device and perform the task at comfortable speed.
Measured: 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
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III scale will be performed to evaluate the general motor state of the participant.18 items, score range: 0 (mild) - 132 (severe)
Measured: 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
Evaluation of changes in neural patterns in response to adaptive protocols that are aligned in time to biomarkers of locomotor states / transitions. Measured variables: Changes in neural signals recorded with the implantable system across all the aforementioned locomotor tasks.
Measured: 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
Out-of-the-lab kinematic monitoring is used to evaluate the evolution of the gait pattern in an ecological environment. Participants will be asked to wear a pair of Nushu X sensorized shoes (Magnes AG, Swizterland - CE-marked as electronic device) with integrated motion feedback sensors during the phase 3 of the study, at CHUV. To monitor the rest of the body kinematics, sensors (Physilog, Mindmaze, Switzerland) will be placed on both wrists of the participants.
Measured: 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).
Sustained efficacy of adaptive DBS during activities of daily life - questionnaire
Evaluation of aDBS in activities of daily living questionnaire is a self-administered questionnaire designed within the scope of this study. It will evaluate the perceived gait quality, and overall motor performance with aDBS during the day
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jocelyne Bloch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jocelyne Bloch, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791902
- Sponsor's protocol ID
- AdapGAIT
- Acronym
- AdapGAIT
- Status last verified
- Dec 2025
- First submitted
- 9 Jan 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Scafa S, de Seta V, Wang R, Sanchez Lopez P, Sanchez Lopez A, Varescon C, Sakr I, Berard N, Bole-Feysot L, Deschenaux C, Enderli I, Thenaisie Y, Burri M, Merlos F, Fleury V, Wicki B, Accolla E, Tziakouri A, Hubsch C, Castro Jimenez M, Bally JF, Puiatti A, Lee K, Lorach H, Collomb-Clerc A, Bloch J, Moraud EM. Activity-dependent adaptive deep brain stimulation improves gait in Parkinson's disease. Nat Med. 2026 Jun 15. doi: 10.1038/s41591-026-04432-4. Online ahead of print.
PubMed 42297979
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Preliminary Safety and Efficacy of Adaptive DBS Aligned to Locomotor States to Improve Locomotor Functions in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT06791902
- Acronym / sponsor ID
- AdapGAIT / AdapGAIT
- Conditions
- Parkinson Disease
- Keywords
- walking deficits, DBS, Parkinson, gait problems, Deep Brain Stimulation, adaptive DBS, aDBS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Jocelyne BlochUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 state-dependent 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 will be spread over a maximum of 5 weeks:
PHASE 1: Eligibility (1 day at CHUV)
- Evaluate Feasibility for aDBS
- Characterize DBS and Movement Modulations
- Assess Global Parkinsonian State
PHASE 2: aDBS therapy setup and efficacy evaluation in different conditions (between 2 to 3 days at CHUV)
- Optimize aDBS Parameters
- Test Safety and Performance
- Evaluate Stability and Robustness
- Daily Life Use of aDBS
The 2 to 3 days of Phase 2 will happenoccur within 10 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptive DBS | Experimental | Device: Adaptive DBS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive DBSAdapting DBS stimulation based on locomotor states to alleviate gait deficits | Device | Adaptive DBS |
Primary outcome
Adverse events
Time frame: Through study completion, a maximum of 5 weeks
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
6 secondary outcomes
Gait performance
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Sustained efficacy of adaptive DBS during activities of daily life - questionnaire
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Derived from this study: PubMed 42297979Scafa S, de Seta V, Wang R, Sanchez Lopez P, Sanchez Lopez A, Varescon C, Sakr I, Berard N, Bole-Feysot L, Deschenaux C, Enderli I, Thenaisie Y, Burri M, Merlos F, Fleury V, Wicki B, Accolla E, Tziakouri A, Hubsch C, Castro Jimenez M, Bally JF, Puiatti A, Lee K, Lorach H, Collomb-Clerc A, Bloch J, Moraud EM. Activity-dependent adaptive deep brain stimulation improves gait in Parkinson's disease. Nat Med. 2026 Jun 15. doi: 10.1038/s41591-026-04432-4. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive DBS in people with Parkinson Disease, run by Jocelyne Bloch at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jocelyne Bloch, Prof. MD (+41 79 556 2951, jocelyne.bloch@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Through study completion, a maximum of 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06791902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.