Trial record 4 of 33 for:
"Dementia With Lewy Bodies"
Effects of Nucleus Basalis of Meynert Stimulation on Cognitive Disorders in Dementia With Lewy Bodies (DEMENSTIM)
This study is currently recruiting participants.
Verified January 2013 by University Hospital, Rouen
Sponsor:
University Hospital, Rouen
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01340001
First received: April 5, 2011
Last updated: January 11, 2013
Last verified: January 2013
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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: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (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: | January 11, 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:
|
Lewy Body Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Parkinsonian Disorders Basal Ganglia Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 21, 2013