Cognitive Deficit Clinical Trial
Official title:
Deep Brain Stimulation (DBS) of the Nucleus Basalis of Meynert (NbM) in Patients With Parkinson's Disease: A Pilot Study
The existing DBS setting in patients with DBS of the globus pallidus interna (GPi), which
aims to treat motor symptoms by a high-frequency stimulation, will be temporarily
reprogramed to stimulate the NbM at a low frequency using the distal electrodes positioned
in the vicinity of the NBM.
This study aims to investigate the neuropsychological effect of low frequency stimulation of
the nucleus basalis of Meynert (NBM) in advanced Parkinson's disease (PD) patients, who were
previously treated with deep brain stimulation (DBS) of the globus pallidus interna (GPi).
The existing DBS setting in patients with GPi DBS, which aims to treat motor symptoms by a
high-frequency stimulation, will be temporarily reprogramed to stimulate the NBM at a low
frequency using the distal electrodes positioned in the vicinity of the NBM.This study
consists of a three-day screening study of the NbM stimulation followed by a two-week,
randomized, single-blind, crossover trial. Between the screening study and the crossover
trial, one week of washout period will be applied to eliminate potential carryover effect
from the previous stimulation.
This study aims to investigate the neuropsychological effect of low frequency stimulation of
the nucleus basalis of Meynert (NBM) in advanced Parkinson's disease (PD) patients, who were
previously treated with deep brain stimulation (DBS) of the globus pallidus interna (GPi).
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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