Dementia With Lewy Bodies Clinical Trial
— DEMENSTIMOfficial title:
Effects of Nucleus Basalis of Meynert Area Electrical Stimulation on Cognitive Behavioral Disorders in Dementia With Lewy Bodies : A Pilot Phase 1 Study
Verified date | April 2018 |
Source | University Hospital, Rouen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6 |
Est. completion date | December 22, 2017 |
Est. primary completion date | December 22, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Maltête David | Rouen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Rouen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | between the assessments (Month 7) and (Month 10) | |
Secondary | 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. | different tests recorded at Month 7 and Month 10 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03996460 -
K0706 for Patients Diagnosed With Dementia With Lewy Bodies
|
Phase 2 | |
Recruiting |
NCT04335994 -
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
|
N/A | |
Recruiting |
NCT02194816 -
Modifiable Variables in Parkinsonism (MVP)
|
||
Active, not recruiting |
NCT01208675 -
The Swedish BioFINDER Study
|
||
Completed |
NCT03538522 -
A Double-Blind, Placebo-Controlled Safety and Efficacy Study of NA-831
|
Phase 2 | |
Recruiting |
NCT03672448 -
The China Longitudinal Aging Study of Cognitive Impairment
|
||
Not yet recruiting |
NCT04760860 -
Terazosin for Dementia With Lewy Bodies
|
Phase 1/Phase 2 | |
Completed |
NCT02910102 -
Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia
|
Phase 2 | |
Terminated |
NCT02928445 -
Long-Term Extension Study of Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: HEADWAY-DLB Extension
|
Phase 2/Phase 3 | |
Terminated |
NCT02871427 -
Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder
|
Phase 2 | |
Completed |
NCT05188105 -
Alpha tACS in Dementia With Lewy Bodies
|
N/A | |
Active, not recruiting |
NCT04167813 -
Trial of Ondansetron as a Parkinson's HAllucinations Treatment
|
Phase 2 | |
Enrolling by invitation |
NCT04954183 -
Development of an EEG Diagnostic for Alzheimer's Disease
|
||
Recruiting |
NCT05326750 -
Non-invasive Neurostimulation as a Tool for Diagnostics and Management for Neurodegenerative Diseases
|
N/A | |
Completed |
NCT01023672 -
"Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies"
|
Phase 4 | |
Completed |
NCT03907748 -
Home-based Family Caregiver-delivered Music and Reading Interventions for People With Dementia
|
N/A | |
Completed |
NCT04649164 -
Learning to PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia
|
N/A | |
Recruiting |
NCT03924414 -
Trial of Parkinson's And Zoledronic Acid
|
Phase 4 | |
Completed |
NCT05885620 -
SAMi Intervention Study to Evaluate Smartwatch Interventions in Persons With MCI and Dementia
|
N/A | |
Not yet recruiting |
NCT04555629 -
Advanced Cognitive Stimulation Therapy Hong Kong (ACST-HK)
|
N/A |