Status:
COMPLETED
Combined Deep Brain Stimulation in Parkinson's Disease
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
The study is a pilot study on Parkinson's disease patients to evaluate Combined deep brain stimulation of the substantia nigra pars reticulata and of the subthalamic nucleus for unresponsive freezing ...
Detailed Description
One of the most challenging and unresolved problems in Parkinson's disease (PD) is the treatment of gait disorders, unresponsive to dopaminergic medication. Additionally, PD patients suffering from se...
Eligibility Criteria
Inclusion
- Idiopathic PD defined as by the MDS Criteria ;
- Patients submitted to STN-DBS, for at least 6 months;
- Patients with STN-DBS at 130Hz;
- Patients with a troublesome FoG according to the "NFOG-Q", Part II Item II ≥ 2 or Part III Item 7 ≥ 2;
- Mini Mental State (MMS) ≥ 25 ;
- Ventral contact of electrodes implanted in the SNr (according to analysis of activated tissue volume models (VTA));
- Patients with stable parkinsonian stimulation parameters and anti-parkinsonian treatments for one month before the inclusion visit;
- Patients with H/Y stage ≤ 3 in the Med ON/Stim On condition (at 130Hz, S-stimulation);
Exclusion
- Patient with atypical Parkinsonian syndrome;
- Patient with severe FoG before DBS, i.e. MDS-UPDRS item 2.13 in Med ON ≥2 or MDS-UPDRS item 3.11 ≥2 in Med On;
- Patient whose antiparkinsonian treatments were modified during the last month before inclusion;
- Patient with H\&Y stage ≥4 in Med On/Stim On (at 130Hz, S-stimulation) ;
Key Trial Info
Start Date :
September 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05415774
Start Date
September 9 2022
End Date
May 10 2023
Last Update
November 28 2025
Active Locations (1)
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1
Uh Toulouse
Toulouse, France, 31000