Clinical trial NCT01340001: Effects of Nucleus Basalis of Meynert Stimulation on Cognitive Disorders in Dementia With Lewy Bodies
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia With Lewy Bodies
Keywords: Dementia with Lewy bodies
Nucleus basalis of Meynert
Deep brain stimulation
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2011-04-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of probable Lewy-body dementia according to the internationally accepted consensus criteria (McKeith, 2005)
* Outpatients, male or female, aged between 18 to 75 years
* Moderate dementia defined by a mini-mental state examination (MMSE) score between 16 and 26
* Stable dose of cholinesterase inhibitors (maximal dose tolerated) for a minimum of 1 months
* Patients receiving antiparkinsonian treatment unmodified for 3 months, if treated
* French as native language
* Written informed consent of the patient
* Written informed consent of the caregiver

Exclusion Criteria:

* Other causes of dementia (Alzheimer dementia, vascular dementia, dementia associated with Parkinson's disease)
* Other causes of extrapyramidal symptoms (Parkinson's disease)
* Patients with a history of severe psychiatric disorders, such as psychosis. Earlier episodes of depression and/or anxiety without hospitalization are not exclusion criteria
* Contraindications for MR imaging (claustrophobia, metallic foreign bodies, pacemakers, etc)
* MRI evidence of cerebral microbleeds
* Surgical contraindications: especially, hemostatic disorders, severe cortical atrophy
* Patients receiving treatments that may interfere with the cholinergic system: anticholinergics, cholinomimetics.
* Patients receiving neuroleptics
* Patients with a history of alcohol or drug abuse
* Pre-existing structural brain abnormalities (such as tumor, infarction, or intracranial hematoma)
* Previous neurosurgical intervention
* Patients with a progressively fatal disease, or life expectancy £ one year
* Asthma
* Severe visual deficit of ophthalmic origin (such as glaucoma, age related macular degeneration, cataract)
* Fertile women not using adequate contraceptive methods
* Women who are pregnant or breast feeding

Primary outcomes:
measure: free recalls of the FCSRT
timeFrame: between the assessments (Month 7) and (Month 10)
Secondary outcomes:
measure: performances on different tests
timeFrame: different tests recorded at Month 7 and Month 10
Other outcomes:
Locations:
city: Rouen
country: France
facility: Maltête David
Study officials:
affiliation: University Hospital of Amiens
name: Olivier GODEFROY, Md, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Lille
name: Luc DEFEBVRE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Poitiers
name: HOUETO Jean-Luc, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Amiens
name: Pierre Krystkowiak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Caen
name: Vincent Delasayette, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maltete D, Wallon D, Bourilhon J, Lefaucheur R, Danaila T, Thobois S, Defebvre L, Dujardin K, Houeto JL, Godefroy O, Krystkowiak P, Martinaud O, Gillibert A, Chastan M, Vera P, Hannequin D, Welter ML, Derrey S. Nucleus Basalis of Meynert Stimulation for Lewy Body Dementia: A Phase I Randomized Clinical Trial. Neurology. 2021 Feb 2;96(5):e684-e697. doi: 10.1212/WNL.0000000000011227. Epub 2020 Nov 16.