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

NCT01340001 | Completed DMC

• 2 other identifiers: 2011/049/HP2011-A00387-34
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia With Lewy Bodies

Keywords

Dementia with Lewy bodies; Nucleus basalis of Meynert; Deep brain stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• performances on different tests

  different tests recorded at Month 7 and Month 10

Study Arms (2)

Sham Electrical stimulation of the nucleus basalis of Meynert

SHAM COMPARATOR

Deep brain stimulation

Procedure: Electrical stimulation of the nucleus basalis of Meynert

Electrical stimulation of the nucleus basalis of Meynert

EXPERIMENTAL

Deep brain stimulation

Procedure: Electrical stimulation of the nucleus basalis of Meynert

Interventions

Electrical stimulation of the nucleus basalis of Meynert PROCEDURE

Differents parameters will be assessed.

Electrical stimulation of the nucleus basalis of Meynert; Sham Electrical stimulation of the nucleus basalis of Meynert

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Maltête David

Rouen, 76031, France

Location

Related Publications (1)

• Maltete D, Wallon D, Bourilhon J, Lefaucheur R, Danaila T, Thobois S, Defebvre L, Dujardin K, Houeto JL, Godefroy O, Krystkowiak P, Martinaud O, Gillibert A, Chastan M, Vera P, Hannequin D, Welter ML, Derrey S. Nucleus Basalis of Meynert Stimulation for Lewy Body Dementia: A Phase I Randomized Clinical Trial. Neurology. 2021 Feb 2;96(5):e684-e697. doi: 10.1212/WNL.0000000000011227. Epub 2020 Nov 16.

  PMID: 33199437 DERIVED

MeSH Terms

Conditions

Lewy Body Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Olivier GODEFROY, Md, PhD

  University Hospital of Amiens

  PRINCIPAL INVESTIGATOR

• Luc DEFEBVRE, MD, PhD

  University Hospital of Lille

  PRINCIPAL INVESTIGATOR

• HOUETO Jean-Luc, MD, PhD

  University Hospital of Poitiers

  PRINCIPAL INVESTIGATOR

• Pierre Krystkowiak, MD, PhD

  University Hospital of Amiens

  PRINCIPAL INVESTIGATOR

• Vincent Delasayette, MD

  University Hospital of Caen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2011
• First Posted: April 21, 2011
• Study Start: October 24, 2012
• Primary Completion: December 22, 2017
• Study Completion: December 22, 2017
• Last Updated: April 30, 2018

Record last verified: 2018-04

Locations

FR (1)