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

NCT ID: NCT05103072

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-21

Study Completion Date

2023-12-31

Brief Summary

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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 .

Detailed Description

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Conditions

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Parkinson Disease Subthalamic Nucleus Stimulation Directional Electrodes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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 ")

No interventions assigned to this group

Guide X Software

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens Picardie

Amiens, Picardie, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Melissa TIR, MD

Role: CONTACT

03.22.08.80.00

Facility Contacts

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Melissa TIR, Dr

Role: primary

+33322667987

References

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Aubignat M, Berro A, Tir M, Lefranc M. Imaging-Guided Subthalamic Nucleus Deep Brain Stimulation Programming for Parkinson Disease: A Real-Life Pilot Study. Neurol Clin Pract. 2024 Dec;14(6):e200326. doi: 10.1212/CPJ.0000000000200326. Epub 2024 Sep 11.

Reference Type DERIVED
PMID: 39282508 (View on PubMed)

Other Identifiers

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PI2021_843_0162

Identifier Type: -

Identifier Source: org_study_id

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