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

April 26, 2018 updated by: University Hospital, Rouen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76031
        • Maltête David

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Sham Electrical stimulation of the nucleus basalis of Meynert
Deep brain stimulation
Procedure: Electrical stimulation of the nucleus basalis of Meynert
Differents parameters will be assessed.
EXPERIMENTAL: Electrical stimulation of the nucleus basalis of Meynert
Deep brain stimulation
Procedure: Electrical stimulation of the nucleus basalis of Meynert
Differents parameters will be assessed.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 24, 2012

Primary Completion (ACTUAL)

December 22, 2017

Study Completion (ACTUAL)

December 22, 2017

Study Registration Dates

First Submitted

April 5, 2011

First Submitted That Met QC Criteria

April 20, 2011

First Posted (ESTIMATE)

April 21, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2018

Last Update Submitted That Met QC Criteria

April 26, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/049/HP
  • 2011-A00387-34 (OTHER: ID-RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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