Recording and Modulation of Brain Activity Through Chronically Implanted Stimulation Electrodes

NCT04703556 | Terminated DMC

• 1 other identifier: DBSgait2020
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Parkinson Disease

Keywords

Gait and balance deficits; Deep brain stimulation; Neural sensing

Outcome Measures

Primary Outcomes (7)

• Changes in gait performance induced by DBS parameters

  Improvements in performance will be evaluated using the results of the 10 meter test

  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

  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

  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.

  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)

  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

  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

  Neural recordings will be performed prior to each UPDRS recording (2 minute recording every 15 minutes)

Interventions

Devices for deep brain stimulation DEVICE

Effect of DBS parameters (amplitude, frequency) on gait and balance deficits, and their dynamical evolution over a pre-defined time

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jocelyne Bloch: lead
• Hôpital du Valais: collaborator

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Equipment and Supplies; Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

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: Neurosurgeon, Professor in Neurosurgery

Model Details: Single blinded study on patients with Parkinson's disease being treated with deep brain stimulation, who still experience severe therapy-resistant gait disorders.

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: January 11, 2021
• Study Start: October 4, 2021
• Primary Completion: September 1, 2022
• Study Completion: July 6, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

CH (1)