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

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ClinicalTrials.gov Identifier: NCT01340001
Recruitment Status : Completed
First Posted : April 21, 2011
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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.


Condition or disease Intervention/treatment Phase
Dementia With Lewy Bodies Procedure: Electrical stimulation of the nucleus basalis of Meynert Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Actual Study Start Date : October 24, 2012
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : December 22, 2017

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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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340001


Locations
France
Maltête David
Rouen, France, 76031
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

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01340001     History of Changes
Other Study ID Numbers: 2011/049/HP
2011-A00387-34 ( Other Identifier: ID-RCB )
First Posted: April 21, 2011    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018

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

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