Dementia with Lewy Bodies
Conditions
Interventions
Cranial ultrasound by [Ultra-Ma]
Sponsors
Manabe Yuta
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Hachinski ischemic score = 0.5 points, with mild cognitive impairment and dementia -MMSE score of 11 to 27 points -1 point >= some of the items of NPI-Q -Diagnosed as "Probable DLB" as per the clinical diagnostic criteria of Lewy body dementia (CDLB Guideline 2017) -Home care patient who satisfy the following criteria. Has a family or caregiver who can always observe the condition. Receiving more than two thirds of nursing care by one parson. -Ability to keep symptom diary by himself/herself or by a caregiver -Either or both of the following treatment has been effective for four weeks or more before the study begins 1) Cholinesterase inhibitors 2) L-dopa preparations
Exclusion criteria
Exclusion criteria: -Active dementia other than Lewy body dementia -Hachinski ischemic score >=5 points and suspected of vascular dementia complications through imaging findings of MRI or CT scan performed within a year before the consent (Focal brain lesions or multiple infarctions, known as the cause of dementia, are observed) -Has any severe neuropsychiatric disorder complications such as cerebrovascular disorder, brain tumor, schizophrenia, epilepsy, normal-pressure hydrocephaly, mental retardation, head trauma with disturbed consciousness, history of brain surgery with residual defect, and so on. -Has severe parkinsonian symptoms (Hoehn & Yahr severity category >= IV) -Unable to perform MMSE and/or NPI-Q tests and so on (has visual and/or hearing impairment, and/or aphasia. -Bedridden patient or inhabitants of an institution(health institution for elderly, rehabilitation facility for elderly, and so on ) -Use of any implantable medical electrical equipment, such as pacemaker and/or implantable defibrillation equipment, which are susceptible to the impact of electromagnetic interference -Any metal components placed inside the skull (ex. indwelling coil) -Use of any In-the-ear (ITE) hearing aid,cochlear implant,or middle ear implant. -Has participated in other clinical research or clinical study for Lewy body dementia within a year before the time of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -NPI-Q -MMSE | — |
Secondary
| Measure | Time frame |
|---|---|
| -UPDRSIII -MoCA-J -Adverse events -Device failure | — |
Contacts
Public ContactTakeshi Murakami
Kanagawa Dental University
Outcome results
None listed