CompletedNot Applicable

Combined Deep Brain Stimulation in Parkinson's Disease

France10 participantsStarted 2022-09-09

Plain-language 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 of gait.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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) ;

What they're measuring

Score change of the " New freezing of gait questionnaire "

Timeframe: ONE MONTH AFTER INCLUSION

Trial details

NCT IDNCT05415774

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-10

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