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

Dementia With Lewy Bodies Clinical Trial

— DEMENSTIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340001
• Other study ID #: 2011/049/HP
• Secondary ID: 2011-A00387-34
• Status: Completed
• Phase: N/A
• Start date: October 24, 2012
• Est. completion date: December 22, 2017

Study information

• Verified date: April 2018
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 22, 2017
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Dementia With Lewy Bodies
• Lewy Body Disease

Intervention

Procedure:
• Electrical stimulation of the nucleus basalis of Meynert
Differents parameters will be assessed.

Locations

Country	Name	City	State
France	Maltête David	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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