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NCT01340001: DEMENSTIM

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

Completed NA Last updated 30 April 2018
What this trial tests

NA trial testing Electrical stimulation of the nucleus basalis of Meynert in Dementia With Lewy Bodies in 6 participants. Completed in 22 December 2017.

Timeline
24 October 2012
Primary endpoint
22 December 2017
22 December 2017

Quick facts

Lead sponsorUniversity Hospital, Rouen
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment6
Start date24 October 2012
Primary completion22 December 2017
Estimated completion22 December 2017
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Rouen

Who can join

Adults 18 to 75, any sex, with Dementia With Lewy Bodies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Challenges and opportunities for improving the landscape for Lewy body dementia clinical trials.
    Goldman JG, Forsberg LK, Boeve BF, Armstrong MJ, et al · · 2020 · cited 44× · PMID 33121510 · DOI 10.1186/s13195-020-00703-5
  2. Nucleus Basalis of Meynert Stimulation for Lewy Body Dementia: A Phase I Randomized Clinical Trial.
    Maltête D, Wallon D, Bourilhon J, Lefaucheur R, et al · · 2021 · cited 24× · PMID 33199437 · DOI 10.1212/wnl.0000000000011227
  3. Deep Brain Stimulation for the Management of Refractory Neurological Disorders: A Comprehensive Review.
    Rissardo JP, Vora NM, Tariq I, Mujtaba A, et al · · 2023 · cited 17× · PMID 38004040 · DOI 10.3390/medicina59111991

Verify or expand the search:

Other recruiting trials for Dementia With Lewy Bodies

Currently open trials in the same condition.

Other University Hospital, Rouen trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01340001.

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