Dementia or mild cognitive impairment with diffuse Lewy bodies
Conditions
Interventions
TBS (stimulus intensity: 120% resting motor threshold
stimulus frequency: 3 magnetic pulses at 20-millisecond intervals delivered at 5 Hz for 30 pulses (total 2 seconds) + 8-second rest
stimulus number: 20 trains per session (total 600 pulses): treatment time approx. 3 minutes) is administered 3 sessions per week for 4 weeks, totaling 12 sessions. The stimulation site is the left dor
Sponsors
Takahashi Shun
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patient diagnosed with probable DLB or probable MCI-LB (2) Patient aged 60 years or older at informed consent (3) Patient with a Geriatric Depression Scale (GDS) score of 6 or higher (4) Patient with a Clinical Dementia Rating (CDR) of 0.5 or 1 (5) Patients for whom written consent to participate in this study is obtained from the patient (in case of CDR 0.5) or their authorized representative (in case of CDR 1) (6) Patients who can come to the hospital for TBS therapy
Exclusion criteria
Exclusion criteria: (1) Patient with contraindication for TBS therapy (those with intracranial metal implants, pacemakers, or other implanted medical devices) (2) Patient with severe agitation or restlessness, where safe TBS administration is deemed difficult (3) Patient with psychotic symptoms consistent with mood symptoms or urgent suicidal ideation (4) Patient with a history of seizures or epileptic seizure (5) Patient diagnosed with neurodegenerative diseases other than Lewy body disease (6) Patient diagnosed with pre-existing psychiatric disorders other than depression (7) Patient with a history of severe cerebrovascular disease judged to be affecting current symptoms (8) Patient with serious medical conditions (9) Patients within 4 weeks of starting anti-dementia drugs or antidepressants (10) Patient currently participating in other interventional studies (11) Patient deemed unsuitable as study subjects by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement rate for 12 sessions of TBS therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Adverse events (2) Changes in depressive symptoms (Hamilton Depression Rating Scale 17/21 items, Patient Health Questionnaire-9, Quick Inventory of Depressive Symptomatology, GDS) (3) Changes in psychiatric symptoms (Neuropsychiatric Inventory) (4) Changes in quality of sleep (Pittsburgh Sleep Questionnaire) (5) Changes in clinical severity (Clinical Global Impression-Severity, Clinical Global Impression-Improvement) (6) Changes in cognitive function (Mini-Mental State Examination) (7) Changes in cognitive fluctuations (Short Fluctuations Questionnaire, Cognitive Fluctuation Inventory) (8) Changes in Parkinson's symptoms (MDS-UPDRS part 3) (9) Changes in activities of daily living (Physical Self Maintenance Scale, Lawton ADL) (10) Changes in caregiver burden (Zarit Caregiver Burden Scale) | — |
Contacts
Public ContactShun Takahashi
The University of Osaka Hospital
Outcome results
None listed