Parkinson DiseasePDNeuroGAITNCT04703556
Recording and Modulation of Brain Activity Through Chronically Implanted Stimulation Electrodes
A study testing Devices for deep brain stimulation in people with Parkinson Disease, run by Jocelyne Bloch at 1 site in Switzerland.
Trial summary
For decades, deep brain stimulation (DBS) therapies have been employed very successfully to alleviate segmental motor symptoms (tremor, brady-kinesia or rigidity) in patients with Parkinson's disease (PD). 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?
- Devices for deep brain stimulation
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Oct 2021to 6 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age: 18 years old or more
- Informed Consent as documented by signature
- Diagnosed with Parkinson's disease, and being treated with deep brain stimulation therapies.
- Exhibiting severe locomotor deficits
- Agree to comply in good faith with all conditions of the recordings.
Who cannot join
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another investigational study in the preceding 30 days
- Previous enrolment into the current study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
Official title: Recording and Modulation of Brain Activity Through Chronically Implanted Stimulation Electrodes in Patients With Parkinson's Disease
For decades, deep brain stimulation (DBS) therapies have been employed very successfully to alleviate segmental motor symptoms (tremor, brady-kinesia or rigidity) in patients with Parkinson's disease (PD). Unfortunately these therapies often fail to alleviate, or can even aggravate, axial deficits such gait and balance disorders. This is presumably due to the divergence in the dynamics of the circuits that control leg function, which are not well addressed with commonly employed stimulation protocols.
To date, patients still endure life-long debilitating gait difficulties that severely affect their everyday mobility, independence and quality of life.
Read more
In recent years, a handful of studies have proposed new paradigms, for instance using different stimulation parameters that are thought to be better suited for targeting the circuits that control lower limb function. Although promising, the resulting observations have been far from conclusive. As a result, the relevant approaches for therapeutic intervention remain unclear, and the underlying mechanisms largely unknown.
Advances on the use of implantable neuromodulation devices and of tech-nologies for monitoring whole-body movement currently allow to study locomotor deficits in ecological environments, enabling the recording and modulation of motor and neural signals while patients perform activities of daily living, chronically, wirelessly and in real time.
Read the detailed description
This project seeks to leverage the latest technological innovations for monitoring and modulating motor and neural states chronically, in order to comprehensively characterize gait deficits in PD, and to clarify the improvements ushered in by varying DBS parameters.
The resulting observations will establish a rigorous understanding that will open new avenues for the design of evidence-based, clinically-relevant DBS strategies for locomotor deficits.
Advances on the use of neural implants for electrical neuromodulation of deep brain structures are opening the unique opportunity to probing the function of dysfunctional circuits in patients suffering from a variety of neurological disorders.
To date, acute experiments using deep brain stimulation (DBS) implants, either in intra-operative setups or shortly after surgery during so-called "externalization" phases, have widened our understan-ding of the neural signatures that underlie various motor and non-motor symptoms, and helped optimi-ze therapeutical parameters to better address such impairments.
For instance, DBS therapies in Parkinson's disease (PD) have been refined over the past decades based on experiments that synergistically (i) explored and uncovered readouts of movement perfor-mance in response to changing stimulation parameters, (ii) identified the underlying neural biomar-kers from recordings of local field potentials, and even (iii) tested closed-loop strategies able to adapt in real-time to ongoing patient-specific requirements.
These advances have mostly been applied to (and been successful for) improving motor signs of the upper-limb such as tremor, bradykinesia or rigidity, which exhibit fast dynamical responses to changes in neuromodulation (in the range of minutes), and which can be studied in the context of simple motor tasks using tethered technologies while patients are safely sitting or lying. These conditions have made it possible to tweak, tune and optimize parameters based on simple easily measurable readouts of motor dysfunction, and to record neural signals with minimal movement-related artefacts in the meantime.
Unfortunately, these straightforward experimental conditions do not apply to the study of axial motor signs, such as locomotion:
- First, gait deficits are multi-faceted and high dimensional: Impairments are not merely restricted to leg movements, but also critically affect lower- and upper-limb coordination, trunk and pelvis oscillations, posture and balance. Their characterization thus requires of multi-modal sensing technologies and analytical methods able to capture all these aspects concurrently.
- Second, the emergence of key deficits (e.g. freezing of gait) necessitates of behavioural tasks that are more physically demanding and potentially risky, often involving multiple repetitions of back-and-forth stepping over longer distances or in environments that resemble everyday life activities. Patients thus need to be in a stable medical condition, and technologies must allow recordings of motor and neural states to be performed wirelessly.
- Finally, the modulation of neural circuits controlling gait have considerably slower dynamics in response to changes in DBS (up to several hours10) than those controlling upper limb function, hence imposing that monitoring and tuning protocols are stretched in time to appropriately capture such changes.
These requirements critically put forward the need to study and devise novel therapies for gait deficits in the chronic state, using multi-modal technologies that can concurrently record neural and motor states remotely, in real-time and for long periods of time.
This project seeks to leverage the latest technological innovations for monitoring and modulating motor and neural states chronically, in order to comprehensively characterize gait deficits in PD while patients execute a range of activities of daily living, and to clarify the improvements brought in by varying DBS parameters.
In past years, a handful of studies have proposed new stimulation paradigms aimed to better target the neural circuits that control lower limb function during gait11. For instance strategies sought to combine varying DBS frequencies, or to target additional anatomical targets. They all highlighted promising, yet far-from-conclusive results. To date, the relevant approaches for therapeutic intervention remain unclear, and the underlying mechanisms largely unknown. Patients still endure life-long, debilitating gait difficulties that severely affect their everyday mobility and independence: they often feel insecure about leaving their homes due to the high risk of fall-related injuries, require personal assistance, and in general see their quality of life significantly diminished.
- Conditions
- Parkinson Disease
- Being tested
- Devices for deep brain stimulation
- Keywords
- Gait and balance deficits, Deep brain stimulation, Neural sensing
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Devices for deep brain stimulationDevice
Effect of DBS parameters (amplitude, frequency) on gait and balance deficits, and their dynamical evolution over a pre-defined time
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gait performance induced by DBS parameters
Improvements in performance will be evaluated using the results of the 10 meter test
Measured: Measurement of performance is performed every 15 minutes up to 60 minutes for every condition.
Changes in gait performance induced by DBS parameters
Improvements in performance will be evaluated using the results of the stand-up and go test
Measured: Measurement of performance is performed every 15 minutes up to 60 minutes for every condition.
Changes in gait performance induced by DBS parameters
Improvements in performance will be evaluated using the results of a test that measures the time to complete a path that includes straight walking and turning to induce (and measure the durations of) freezing of gait
Measured: Measurement of performance is performed every 15 minutes up to 60 minutes for every condition.
Changes in gait quality induced by DBS parameters
Quality in gait will compare the walking patterns of each patient with respect to healthy subjects : for that, multi-factorial analysis will be applied on recordings of kinematics (3D positions of body-joints recorded using a motion capture system). These multi-faceted signals are discretised per gait cycle, zscored, and their correlations extracted through Principal Component Analysis, which allows to identify key patterns being modulated with the therapy.
Measured: Quality of gait patterns is performed during one walking recording, every 15 minutes up to 60 minutes for every condition.
Changes in global motor scores induced by DBS parameters
Unified Parkinson's Disease Rating Scores (UPDRS III)
Measured: UPDRS scores will be measured by an expert clinician every 15 minutes after each gait recording, up to 60 minutes per condition
Changes in brain dynamics induced by DBS parameters
Changes in neural signatures (STN LFP for patients implanted with an IPG that allows sensing, e.g. Percept PC) will be measured at rest, to extract their temporal evolution and their correlation with motor scores for each condition
Measured: Neural recordings will be performed prior to each UPDRS recording (every 15 minutes)
Changes in brain dynamics induced by DBS parameters
Changes in neural signatures (EEG at rest) will be measured to extract temporal changes and their correlation with motor scores for each condition
Measured: Neural recordings will be performed prior to each UPDRS recording (2 minute recording every 15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start4 Oct 2021
- Primary completion1 Sep 2022
- Study completion6 Jul 2023
Why it stopped: Protocol too complex for study population and difficulty to recruit participants with DBS and gait deficits
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Single blinded study on patients with Parkinson's disease being treated with deep brain stimulation, who still experience severe therapy-resistant gait disorders.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jocelyne Bloch
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital du Valais
- Responsible party
- Sponsor-investigator, Jocelyne Bloch, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703556
- Sponsor's protocol ID
- DBSgait2020
- Acronym
- PDNeuroGAIT
- Status last verified
- Sep 2023
- First submitted
- 1 Dec 2020
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized data may be shared upon completion of the study. The process is yet to be defined
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recording and Modulation of Brain Activity Through Chronically Implanted Stimulation Electrodes in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04703556
- Acronym / sponsor ID
- PDNeuroGAIT / DBSgait2020
- Conditions
- Parkinson Disease
- Keywords
- Gait and balance deficits, Deep brain stimulation, Neural sensing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol too complex for study population and difficulty to recruit participants with DBS and gait deficits
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Jocelyne BlochUniversity, hospital or other
- Collaborators
- Hôpital du Valais
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 11 Jan 2021 (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.
For decades, deep brain stimulation (DBS) therapies have been employed very successfully to alleviate segmental motor symptoms (tremor, brady-kinesia or rigidity) in patients with Parkinson's disease (PD). Unfortunately these therapies often fail to alleviate, or can even aggravate, axial deficits such gait and balance disorders. This is presumably due to the divergence in the dynamics of the circuits that control leg function, which are not well addressed with commonly employed stimulation protocols.
To date, patients still endure life-long debilitating gait difficulties that severely affect their everyday mobility, independence and quality of life.
In recent years, a handful of studies have proposed new paradigms, for instance using different stimulation parameters that are thought to be better suited for targeting the circuits that control lower limb function. Although promising, the resulting observations have been far from conclusive. As a result, the relevant approaches for therapeutic intervention remain unclear, and the underlying mechanisms largely unknown.
Advances on the use of implantable neuromodulation devices and of tech-nologies for monitoring whole-body movement currently allow to study locomotor deficits in ecological environments, enabling the recording and modulation of motor and neural signals while patients perform activities of daily living, chronically, wirelessly and in real time.
Detailed description
This project seeks to leverage the latest technological innovations for monitoring and modulating motor and neural states chronically, in order to comprehensively characterize gait deficits in PD, and to clarify the improvements ushered in by varying DBS parameters.
The resulting observations will establish a rigorous understanding that will open new avenues for the design of evidence-based, clinically-relevant DBS strategies for locomotor deficits.
Advances on the use of neural implants for electrical neuromodulation of deep brain structures are opening the unique opportunity to probing the function of dysfunctional circuits in patients suffering from a variety of neurological disorders.
To date, acute experiments using deep brain stimulation (DBS) implants, either in intra-operative setups or shortly after surgery during so-called "externalization" phases, have widened our understan-ding of the neural signatures that underlie various motor and non-motor symptoms, and helped optimi-ze therapeutical parameters to better address such impairments.
For instance, DBS therapies in Parkinson's disease (PD) have been refined over the past decades based on experiments that synergistically (i) explored and uncovered readouts of movement perfor-mance in response to changing stimulation parameters, (ii) identified the underlying neural biomar-kers from recordings of local field potentials, and even (iii) tested closed-loop strategies able to adapt in real-time to ongoing patient-specific requirements.
These advances have mostly been applied to (and been successful for) improving motor signs of the upper-limb such as tremor, bradykinesia or rigidity, which exhibit fast dynamical responses to changes in neuromodulation (in the range of minutes), and which can be studied in the context of simple motor tasks using tethered technologies while patients are safely sitting or lying. These conditions have made it possible to tweak, tune and optimize parameters based on simple easily measurable readouts of motor dysfunction, and to record neural signals with minimal movement-related artefacts in the meantime.
Unfortunately, these straightforward experimental conditions do not apply to the study of axial motor signs, such as locomotion:
- First, gait deficits are multi-faceted and high dimensional: Impairments are not merely restricted to leg movements, but also critically affect lower- and upper-limb coordination, trunk and pelvis oscillations, posture and balance. Their characterization thus requires of multi-modal sensing technologies and analytical methods able to capture all these aspects concurrently.
- Second, the emergence of key deficits (e.g. freezing of gait) necessitates of behavioural tasks that are more physically demanding and potentially risky, often involving multiple repetitions of back-and-forth stepping over longer distances or in environments that resemble everyday life activities. Patients thus need to be in a stable medical condition, and technologies must allow recordings of motor and neural states to be performed wirelessly.
- Finally, the modulation of neural circuits controlling gait have considerably slower dynamics in response to changes in DBS (up to several hours10) than those controlling upper limb function, hence imposing that monitoring and tuning protocols are stretched in time to appropriately capture such changes.
These requirements critically put forward the need to study and devise novel therapies for gait deficits in the chronic state, using multi-modal technologies that can concurrently record neural and motor states remotely, in real-time and for long periods of time.
This project seeks to leverage the latest technological innovations for monitoring and modulating motor and neural states chronically, in order to comprehensively characterize gait deficits in PD while patients execute a range of activities of daily living, and to clarify the improvements brought in by varying DBS parameters.
In past years, a handful of studies have proposed new stimulation paradigms aimed to better target the neural circuits that control lower limb function during gait11. For instance strategies sought to combine varying DBS frequencies, or to target additional anatomical targets. They all highlighted promising, yet far-from-conclusive results. To date, the relevant approaches for therapeutic intervention remain unclear, and the underlying mechanisms largely unknown. Patients still endure life-long, debilitating gait difficulties that severely affect their everyday mobility and independence: they often feel insecure about leaving their homes due to the high risk of fall-related injuries, require personal assistance, and in general see their quality of life significantly diminished.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Single blinded study on patients with Parkinson's disease being treated with deep brain stimulation, who still experience severe therapy-resistant gait disorders.
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18 years old or more
- Informed Consent as documented by signature
- Diagnosed with Parkinson's disease, and being treated with deep brain stimulation therapies.
- Exhibiting severe locomotor deficits
- Agree to comply in good faith with all conditions of the recordings.
Key exclusion criteria (3 listed)
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another investigational study in the preceding 30 days
- Previous enrolment into the current study
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 |
|---|---|---|
| Devices for deep brain stimulationEffect of DBS parameters (amplitude, frequency) on gait and balance deficits, and their dynamical evolution over a pre-defined time | Device | – |
Primary outcome
Changes in gait performance induced by DBS parameters
Time frame: Measurement of performance is performed every 15 minutes up to 60 minutes for every condition.
Improvements in performance will be evaluated using the results of the 10 meter test
Changes in gait performance induced by DBS parameters
Time frame: Measurement of performance is performed every 15 minutes up to 60 minutes for every condition.
Improvements in performance will be evaluated using the results of the stand-up and go test
Changes in gait performance induced by DBS parameters
Time frame: Measurement of performance is performed every 15 minutes up to 60 minutes for every condition.
Improvements in performance will be evaluated using the results of a test that measures the time to complete a path that includes straight walking and turning to induce (and measure the durations of) freezing of gait
Changes in gait quality induced by DBS parameters
Time frame: Quality of gait patterns is performed during one walking recording, every 15 minutes up to 60 minutes for every condition.
Quality in gait will compare the walking patterns of each patient with respect to healthy subjects : for that, multi-factorial analysis will be applied on recordings of kinematics (3D positions of body-joints recorded using a motion capture system). These multi-faceted signals are discretised per gait cycle, zscored, and their correlations extracted through Principal Component Analysis, which allows to identify key patterns being modulated with the therapy.
Changes in global motor scores induced by DBS parameters
Time frame: UPDRS scores will be measured by an expert clinician every 15 minutes after each gait recording, up to 60 minutes per condition
Unified Parkinson's Disease Rating Scores (UPDRS III)
Changes in brain dynamics induced by DBS parameters
Time frame: Neural recordings will be performed prior to each UPDRS recording (every 15 minutes)
Changes in neural signatures (STN LFP for patients implanted with an IPG that allows sensing, e.g. Percept PC) will be measured at rest, to extract their temporal evolution and their correlation with motor scores for each condition
Changes in brain dynamics induced by DBS parameters
Time frame: Neural recordings will be performed prior to each UPDRS recording (2 minute recording every 15 minutes)
Changes in neural signatures (EEG at rest) will be measured to extract temporal changes and their correlation with motor scores for each condition
Results and safety
The study was stopped early (reason given: Protocol too complex for study population and difficulty to recruit participants with DBS and gait deficits). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: Undecided. Anonymized data may be shared upon completion of the study. The process is yet to be defined
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Devices for deep brain stimulation 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 8 Sep 2023. 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?
The study was stopped early (reason given: Protocol too complex for study population and difficulty to recruit participants with DBS and gait deficits). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gait performance induced by DBS parameters (time frame: Measurement of performance is performed every 15 minutes up to 60 minutes for every condition.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2023.