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

Primary Purpose

Dementia With Lewy Bodies

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electrical stimulation of the nucleus basalis of Meynert
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia With Lewy Bodies focused on measuring Dementia with Lewy bodies, Nucleus basalis of Meynert, Deep brain stimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Maltête David

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham Electrical stimulation of the nucleus basalis of Meynert

Electrical stimulation of the nucleus basalis of Meynert

Arm Description

Deep brain stimulation

Deep brain stimulation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 5, 2011
Last Updated
April 26, 2018
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT01340001
Brief Title
Effects of Nucleus Basalis of Meynert Stimulation on Cognitive Disorders in Dementia With Lewy Bodies
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 24, 2012 (Actual)
Primary Completion Date
December 22, 2017 (Actual)
Study Completion Date
December 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia With Lewy Bodies
Keywords
Dementia with Lewy bodies, Nucleus basalis of Meynert, Deep brain stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham Electrical stimulation of the nucleus basalis of Meynert
Arm Type
Sham Comparator
Arm Description
Deep brain stimulation
Arm Title
Electrical stimulation of the nucleus basalis of Meynert
Arm Type
Experimental
Arm Description
Deep brain stimulation
Intervention Type
Procedure
Intervention Name(s)
Electrical stimulation of the nucleus basalis of Meynert
Intervention Description
Differents parameters will be assessed.
Primary Outcome Measure Information:
Title
free recalls of the FCSRT
Description
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.
Time Frame
between the assessments (Month 7) and (Month 10)
Secondary Outcome Measure Information:
Title
performances on different tests
Description
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.
Time Frame
different tests recorded at Month 7 and Month 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier GODEFROY, Md, PhD
Organizational Affiliation
University Hospital of Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luc DEFEBVRE, MD, PhD
Organizational Affiliation
University Hospital of Lille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
HOUETO Jean-Luc, MD, PhD
Organizational Affiliation
University Hospital of Poitiers
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre Krystkowiak, MD, PhD
Organizational Affiliation
University Hospital of Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincent Delasayette, MD
Organizational Affiliation
University Hospital of Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maltête David
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33199437
Citation
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.
Results Reference
derived

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

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