Local Fields Potentientals of the Subthalamic Nucleus in Patients With Parkinson's Disease

NCT05820425 | Recruiting

• 2 other identifiers: 38RC21.03942022-A00004-39
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Neuropsychiatric fluctuations are frequent and debilitating non-motor disorders in Parkinson's disease. Subthalamic stimulation is an effective treatment for motor and non-motor neuropsychiatric fluctuations in Parkinson's disease, which has also allowed to better characterize the electrophysiological activity of the subthalamic nucleus in patients with Parkinson's disease. Numerous studies have been carried out on electrophysiological activity correlated with motor disorders, showing that akinesia is correlated with an abnormal synchronization in the beta frequency band (13-30Hz) in the dorsal motor part of the subnucleus. thalamic. This abnormal synchronization is reduced when the akinesia improves with dopaminergic treatment. On the cognitive-behavioural non-motor side, electrophysiological studies are less numerous, but suggest an involvement of the subthalamic nucleus (with an abnormal synchronization in the lower frequency bands). Currently, the electrophysiological correlates of neuropsychiatric fluctuations are unknown. In addition, all studies on electrophysiological activity are carried out immediately after the intervention, and before the implantation of the pacemaker. It is unknown whether the electrophysiological correlates of motor and non-motor fluctuations change following their transient improvement observed in the setting of chronic stimulation of the subthalamic nucleus and chronic reduction of dopaminergic treatment. The new PERCEPT stimulators (Medtronic) available on the market make it possible to record long-term electrophysiological activity for the first time. With this study we want to define the electrophysiological markers of neuropsychiatric fluctuations and their change over time.

Conditions

Parkinson Disease

Keywords

Local Field Potentials; Neuropsychiatric Fluctuations Scale; Subthalamic nucleus stimulation

Outcome Measures

Primary Outcomes (3)

• The LFPs recordings from the STN correlating with the neuropsychiatric OFF and ON

  Correlation will be performed within a general mixed effect model approach. The dependent variable will be the power spectral density (PSD, expressed as logpower (µV\^2)) of the subthalamic nucleus local field potentials estimated with the Welch method. The independant variable will be measured using the neuropsychiatric fluctuations scale score.

  in the 10 days following surgery

• The LFPs recordings from the STN correlating with the neuropsychiatric OFF and ON

  Correlation will be performed within a general mixed effect model approach. The dependent variable will be the power spectral density (PSD, expressed as logpower (µV\^2)) of the subthalamic nucleus local field potentials estimated with the Welch method. The independant variable will be measured using the neuropsychiatric fluctuations scale score.

  at 3 months after surgery

• The LFPs recordings from the STN correlating with the neuropsychiatric OFF and ON

  Correlation will be performed within a general mixed effect model approach. The dependent variable will be the power spectral density (PSD, expressed as logpower (µV\^2)) of the subthalamic nucleus local field potentials estimated with the Welch method. The independant variable will be measured using the neuropsychiatric fluctuations scale score.

  at 1 year after surgery

Study Arms (1)

Patients with Parkinson's disease with fluctuations and/or dyskinesias treated by STN DBS

Patients with Parkinson's disease with fluctuations and/or dyskinesias treated by STN DBS, using PERCEPT device (Medtronic)

Other: LFP and EEG recording

Interventions

LFP and EEG recording OTHER

STN LFP and EEG recording during the OFF and ON medication condition

Patients with Parkinson's disease with fluctuations and/or dyskinesias treated by STN DBS

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PD patients with motor and non motor fluctuations, operated within the last 10 days for STN stimulation (PERCEPT implant)

You may qualify if:

• Age between 30 and 75 years
• Diagnosis of Parkinson's disease with fluctuations and/or dyskinesias
• Ability to collaborate and fill a questionnaire in the OFF state condition (this criterion will be assessed based on the results of the preoperative screening to retain indication for STN stimulation, which takes place whenever a PD patient has to undergo DBS surgery)
• Surgery for bilateral STN stimulation with a Percept® (Medtronic) in the last 10 days
• Absence of dementia (defined as MoCA score \> 24)

You may not qualify if:

• Active psychosis
• Patients unable to provide an informed consent or under gardianship
• Patients under judicial supervision or deprived of liberty
• Pregnancy and breastfeeding

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38043, France

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Anna Castrioto, MD, PhD

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Pelissier, MsC

CONTACT

4 76 76 94 59; ppelissier@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 19, 2023
• Study Start: April 7, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)