Clinical Trial: Effects of Nucleus Basalis of Meynert Stimulation on Cognitive Disorders in Dementia With Lewy Bodies

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effects of Nucleus Basalis of Meynert Area Electrical Stimulation on Cognitive Behavioral Disorders in Dementia With Lewy Bodies : A Pilot Phase 1 Study

Brief Summary:

Deep brain stimulation has been developed as a substitute for the classical lesioning methods previously used in stereotactic and functional neurosurgery. Recent, anecdotal cases reports suggested that electrical stimulation of the cholinergic output of the Nucleus Basalis of Meynert (NBM) may improve cognitive performances, especially the memory tasks.

The present study aims to assess the effect of bilateral electrical stimulation of the NBM on the mnesic performance [assessed by the sum of the three free recalls of the Free and Cued Selective Recall Reminding Test (FCSRT)] in patients diagnosed with probable, moderate, Dementia with Lewy Bodies.


Detailed Summary:
Sponsor: University Hospital, Rouen

Current Primary Outcome: free recalls of the FCSRT [ Time Frame: between the assessments (Month 7) and (Month 10) ]

The primary endpoint of the study is the difference in the sum of the three free recalls of the FCSRT between the assessments (M7) and (M10), i.e. the comparison of the performances with and without NBM electrical stimulation.


Original Primary Outcome: Same as current

Current Secondary Outcome: performances on different tests [ Time Frame: different tests recorded at Month 7 and Month 10 ]

Comparison will be made between the performances on different tests recorded at M7 and M10, to evaluate the effect of bilateral electrical stimulation of the NBM on cognitivo-behavioral disorders.


Original Secondary Outcome: Same as current

Information By: University Hospital, Rouen

Dates:
Date Received: April 5, 2011
Date Started: October 2012
Date Completion: October 2017
Last Updated: December 6, 2016
Last Verified: December 2016