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

University Hospital, Rouen

Status

Completed

Conditions

Dementia With Lewy Bodies

Treatments

Procedure: Electrical stimulation of the nucleus basalis of Meynert

Study type

Interventional

Funder types

Other

Identifiers

NCT01340001

2011-A00387-34 (Other Identifier)

2011/049/HP

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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