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Combined Deep Brain Stimulation in Parkinson's Disease
Combined Deep Brain Stimulation in Parkinson's Disease

NCT05415774

CompletedNA

Sponsor: University Hospital, Toulouse

Conditions: Parkinson Disease

Interventions: 1 : S-C1-C2, 2 : S-C2-C1, 3 : C1 - S - C2, 4 : C1 -C2 - S, 5 : C2 - S - C1

Countries: France

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 of gait.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

1. Idiopathic PD defined as by the MDS Criteria ;
2. Patients submitted to STN-DBS, for at least 6 months;
3. Patients with STN-DBS at 130Hz;
4. Patients with a troublesome FoG according to the "NFOG-Q", Part II Item II ≥ 2 or Part III Item 7 ≥ 2;
5. Mini Mental State (MMS) ≥ 25 ;
6. Ventral contact of electrodes implanted in the SNr (according to analysis of activated tissue volume models (VTA));
7. Patients with stable parkinsonian stimulation parameters and anti-parkinsonian treatments for one month before the inclusion visit;
8. Patients with H/Y stage ≤ 3 in the Med ON/Stim On condition (at 130Hz, S-stimulation);

Exclusion Criteria:

1. Patient with atypical Parkinsonian syndrome;
2. 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;
3. Patient whose antiparkinsonian treatments were modified during the last month before inclusion;
4. Patient with H\&Y stage ≥4 in Med On/Stim On (at 130Hz, S-stimulation) ;
Locations (1)
  • Toulouse, France