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

Study Overview
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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.

Official Title
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Effects of Nucleus Basalis of Meynert Area Electrical Stimulation on Cognitive Behavioral Disorders in Dementia With Lewy Bodies : A Pilot Phase 1 Study

Conditions
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Dementia With Lewy Bodies

Intervention / Treatment
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* Procedure: Electrical stimulation of the nucleus basalis of Meynert


Participation Criteria
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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) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham Electrical stimulation of the nucleus basalis of Meynert<br>Deep brain stimulation | Procedure: Electrical stimulation of the nucleus basalis of Meynert<br>* Differents parameters will be assessed.<br>|
| Experimental: Electrical stimulation of the nucleus basalis of Meynert<br>Deep brain stimulation | Procedure: Electrical stimulation of the nucleus basalis of Meynert<br>* Differents parameters will be assessed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| free recalls of the FCSRT | 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. | between the assessments (Month 7) and (Month 10) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| performances on different tests | 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. | different tests recorded at Month 7 and Month 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia with Lewy bodies, Nucleus basalis of Meynert, Deep brain stimulation