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NSTBOS: Subthalamic Nucleus Stimulation With Directional Leads on Patients With Parkinson Disease at Fluctuations and Dyskinesia Stage

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT05103072
Collaborator
(none)
13
Enrollment
1
Location
23.3
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients with subthalamic nucleus have to go through a lot of examinations and tests, before and after surgery which is difficult, sometimes painful, for the patient.

The investigators used to chose the best plot of the leads for stimulation by a procedure long and exhausting for the patient and the examinator.

The investigators can chose the plot using a software (Guide Xt), which can delete the exhausting test.

The investigators would like to study the non inferiority of this tool to choose the best plot .

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    13 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Subthalamic Nucleus Stimulation With Directional Leads on Patients With Parkinson Disease at Fluctuations and Dyskinesia Stage
    Actual Study Start Date :
    Sep 21, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    testing all the plots

    the investigator chose the best plot of the leads for stimulation by a procedure long and exhausting for the patient and the examinator (" plot by plot ")
    Guide X Software

    the investigator can chose the plot using a software (Guide Xt), which can delete the exhausting test

    Outcome Measures

    Primary Outcome Measures

    1. Increase of MDS UPDRS 3 score [3 months]

      The MDS-UPDRS was developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. The MDS-UPDRS has four parts, namely, I: Non-motor Experiences of Daily Living; II: Motor Experiences of DailyLiving; III: Motor Examination; IV: Motor Complications.Twenty questions are completed by the patient/caregiver. Item-specific instructions and an appendix of complementary additional scales are provided.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age : >18Y

    • All patient with Parkinson disease eligible for sub thalamic surgery (CAPSIT criterias) in CHU AMIENS

    Exclusion Criteria:
    • patient doesn't consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Amiens Picardie Amiens Picardie France 80054

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire, Amiens

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire, Amiens
    ClinicalTrials.gov Identifier:
    NCT05103072
    Other Study ID Numbers:
    • PI2021_843_0162
    First Posted:
    Nov 2, 2021
    Last Update Posted:
    Nov 2, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire, Amiens
    Parkinson Disease
    Subthalamic nucleus stimulation
    directional electrodes
    Additional relevant MeSH terms:
    Parkinson Disease
    Dyskinesias

    Study Results

    No Results Posted as of Nov 2, 2021