Dementia With Lewy Bodies
Conditions
Keywords
Dementia with Lewy bodies, Nucleus basalis of Meynert, Deep brain stimulation
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.
Interventions
PROCEDUREElectrical stimulation of the nucleus basalis of Meynert
Differents parameters will be assessed.
Sponsors
University Hospital, Rouen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Outcome results
None listed