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NCT Number: NCT01340001

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

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.

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Key information

Conditions

Dementia With Lewy Bodies Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dementia Lewy Body Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maltête David

Rouen, 76031, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrical stimulation of the nucleus basalis of Meynert

Procedure

Differents parameters will be assessed.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Acronym: DEMENSTIM

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Apr 21, 2011
Registry last updated
Apr 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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