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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-24

Study Completion Date

2017-12-22

Brief Summary

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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.

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RECRUITING PHASE1

Detailed Description

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Conditions

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Dementia With Lewy Bodies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sham Electrical stimulation of the nucleus basalis of Meynert

Deep brain stimulation

Group Type SHAM_COMPARATOR

Electrical stimulation of the nucleus basalis of Meynert

Intervention Type PROCEDURE

Differents parameters will be assessed.

Electrical stimulation of the nucleus basalis of Meynert

Deep brain stimulation

Group Type EXPERIMENTAL

Electrical stimulation of the nucleus basalis of Meynert

Intervention Type PROCEDURE

Differents parameters will be assessed.

Interventions

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Electrical stimulation of the nucleus basalis of Meynert

Differents parameters will be assessed.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No