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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05103072
Other study ID # PI2021_843_0162
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 21, 2021
Est. completion date December 2023

Study information

Verified date February 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Melissa TIR, MD
Phone 03.22.08.80.00
Email tir.melissa@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 .


Recruitment information / eligibility

Status Recruiting
Enrollment 13
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Amiens Picardie Amiens Picardie

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Increase of MDS UPDRS 3 score 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.
3 months
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