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

Not Applicable

Completed

• Conditions: Dementia With Lewy Bodies
• Interventions: Procedure: Electrical stimulation of the nucleus basalis of Meynert

• Registration Number: NCT01340001
• Lead Sponsor: University Hospital, Rouen

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 Description

Not available

Study Timeline

• Study First Submitted: 2011-04-05
• Study First Submitted QC: 2011-04-20
• Study First Posted: 2011-04-21
• Study Start: 2012-10-24
• Primary Completion: 2017-12-22
• Study Completion: 2017-12-22
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-26
• Last Update Posted: 2018-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Electrical stimulation of the nucleus basalis of Meynert	Electrical stimulation of the nucleus basalis of Meynert	Deep brain stimulation
Sham Electrical stimulation of the nucleus basalis of Meynert	Electrical stimulation of the nucleus basalis of Meynert	Deep brain stimulation

Primary Outcome Measures

Name	Time	Method
free recalls of the FCSRT	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.

Secondary Outcome Measures

Name	Time	Method
performances on different tests	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.

Trial Locations

Locations (1)

Maltête David; 🇫🇷 Rouen, France