Dementia With Lewy BodiesDEMENSTIMNCT01340001
Effects of Nucleus Basalis of Meynert Stimulation on Cognitive Disorders in Dementia With Lewy Bodies
A study testing Electrical stimulation of the nucleus basalis of Meynert in people with Dementia With Lewy Bodies, run by University Hospital, Rouen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dementia With Lewy Bodies
- What is being tested?
- Electrical stimulation of the nucleus basalis of Meynert
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 24 Oct 2012to 22 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Dementia With Lewy Bodies
- Being tested
- Electrical stimulation of the nucleus basalis of Meynert
- Keywords
- Dementia with Lewy bodies, Nucleus basalis of Meynert, Deep brain stimulation
- Medical subject headings
- Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulation of the nucleus basalis of MeynertProcedure or surgery
Differents parameters will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Sham Electrical stimulation of the nucleus basalis of Meynert | Sham comparator | Deep brain stimulation Receives: Procedure: Electrical stimulation of the nucleus basalis of Meynert |
| Electrical stimulation of the nucleus basalis of Meynert | Experimental | Deep brain stimulation Receives: Procedure: Electrical stimulation of the nucleus basalis of Meynert |
What is being measured
The primary outcome is the main question the study is designed to answer.
free recalls of the FCSRT
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.
Measured: between the assessments (Month 7) and (Month 10)
Secondary outcomes (1)
performances on different tests
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.
Measured: different tests recorded at Month 7 and Month 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2011 (estimated)
- Study start24 Oct 2012
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dementia With Lewy BodiesStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier GODEFROY, Md, PhD, Principal investigator, University Hospital of AmiensLuc DEFEBVRE, MD, PhD, Principal investigator, University Hospital of LilleHOUETO Jean-Luc, MD, PhD, Principal investigator, Poitiers University HospitalPierre Krystkowiak, MD, PhD, Principal investigator, University Hospital of AmiensVincent Delasayette, MD, Principal investigator, University Hospital of Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340001
- Sponsor's protocol ID
- 2011/049/HP
- Other IDs
- 2011-A00387-34
- Acronym
- DEMENSTIM
- Status last verified
- Apr 2018
- First submitted
- 5 Apr 2011
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maltete D, Wallon D, Bourilhon J, Lefaucheur R, Danaila T, Thobois S, Defebvre L, Dujardin K, Houeto JL, Godefroy O, Krystkowiak P, Martinaud O, Gillibert A, Chastan M, Vera P, Hannequin D, Welter ML, Derrey S. Nucleus Basalis of Meynert Stimulation for Lewy Body Dementia: A Phase I Randomized Clinical Trial. Neurology. 2021 Feb 2;96(5):e684-e697. doi: 10.1212/WNL.0000000000011227. Epub 2020 Nov 16.
PubMed 33199437
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01340001
- Acronym / sponsor ID
- DEMENSTIM / 2011/049/HP
- Conditions
- Dementia With Lewy Bodies
- Keywords
- Dementia with Lewy bodies, Nucleus basalis of Meynert, Deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 24 Oct 2012 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 21 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Electrical stimulation of the nucleus basalis of Meynert | Sham comparator | Procedure: Electrical stimulation of the nucleus basalis of MeynertDeep brain stimulation |
| Electrical stimulation of the nucleus basalis of Meynert | Experimental | Procedure: Electrical stimulation of the nucleus basalis of MeynertDeep brain stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical stimulation of the nucleus basalis of MeynertDifferents parameters will be assessed. | Procedure or surgery | Electrical stimulation of the nucleus basalis of Meynert, Sham Electrical stimulation of the nucleus basalis of Meynert |
Primary outcome
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.
1 secondary outcome
performances on different tests
Time frame: different tests recorded at Month 7 and Month 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Derived from this study: PubMed 33199437Maltete D, Wallon D, Bourilhon J, Lefaucheur R, Danaila T, Thobois S, Defebvre L, Dujardin K, Houeto JL, Godefroy O, Krystkowiak P, Martinaud O, Gillibert A, Chastan M, Vera P, Hannequin D, Welter ML, Derrey S. Nucleus Basalis of Meynert Stimulation for Lewy Body Dementia: A Phase I Randomized Clinical Trial. Neurology. 2021 Feb 2;96(5):e684-e697. doi: 10.1212/WNL.0000000000011227. Epub 2020 Nov 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier GODEFROY, Md, PhD principal investigator
University Hospital of Amiens
Luc DEFEBVRE, MD, PhD principal investigator
University Hospital of Lille
HOUETO Jean-Luc, MD, PhD principal investigator
Poitiers University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation of the nucleus basalis of Meynert in people with Dementia With Lewy Bodies, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
free recalls of the FCSRT (time frame: between the assessments (Month 7) and (Month 10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01340001, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.