Trial record 6 of 33 for:    DEMENTIA, LEWY BODY

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

This study is currently recruiting participants.
Verified October 2013 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01340001
First received: April 5, 2011
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Dementia With Lewy Bodies
Procedure: Electrical stimulation of the nucleus basalis of Meynert
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • free recalls of the FCSRT [ Time Frame: between the assessments (Month 7) and (Month 10) ] [ Designated as safety issue: No ]
    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 [ Time Frame: different tests recorded at Month 7 and Month 10 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 6
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Electrical stimulation of the nucleus basalis of Meynert
Deep brain stimulation : on versus off
Procedure: Electrical stimulation of the nucleus basalis of Meynert
Differents parameters will be assessed.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01340001

Contacts
Contact: David MALTETE, MD, PhD (0)232888037 ext +33 david.maltete@chu-rouen.fr

Locations
France
Maltête David Recruiting
Rouen, France, 76031
Contact: David MAltête, MD,PhD    0670075564    david.maltete@chu-rouen.fr   
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01340001     History of Changes
Other Study ID Numbers: 2011/049/HP, 2011-A00387-34
Study First Received: April 5, 2011
Last Updated: October 15, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
Dementia with Lewy bodies
Nucleus basalis of Meynert
Deep brain stimulation

Additional relevant MeSH terms:
Dementia
Lewy Body Disease
Delirium, Dementia, Amnestic, Cognitive Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 16, 2014