F06.7 G30
Conditions
Interventions
Group 1: Therapy arm 1: 18 patients, UHV-stimulation, 1 hour daily stimulation, over a period of 6 months
Group 2: Therapy arm 2: 18 patients, sham stimulation. These patients will be subjected to t
Sponsors
Charité - Berlin University Medicine, Department of Psychiatry and Neurosciences at the Charité Campus Mitte
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: •50 years of age or older • AD diagnosis (MMSE > 14 < 26) • CSF-based AD diagnosis (< 550 pg/mL) • Subjective memory impairment • Sufficient visual acuity • Stable CNS-active medication in the last 6 months • Ability and readiness to consent into the participation
Exclusion criteria
Exclusion criteria: • Epilepsy or reduced seizure threshold • Stroke in the last 24 months • Other diagnosed mental or neurological disorders that affect the ability to consent. • Specific to MRI biomarkers: o Non-MR-compatible implants o Non-MR-compatible pacemakers o Metal bodies or splinters in critical localization o Sensorineural hearing loss from 30 bB o Tinnitus o Pregnancy • Specific for CSF sampling o Pregnancy o Increased intracranial pressure o Tendency to bleed o Inflammation in the puncture area
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability and safety of UHV-Stimulation assessed via weekly self-ratings (Adverse Event Report via the virtual reality sickness questionnaire. Subjective Assessment of the tolerability of the stimulation via a self-designed questionnaire) . | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Alzheimer disease cognitive and behavioral symptoms assessed via neuropsychological test batteries, sleep quality, and physical and mental well-being, assessed after 3 months, after 6 months and after 3 months follow-up. Changes in biomarkers of Alzheimer's disease assessed from blood and CSF samples, assessed after 6 months. Changes in functional connectivity assessed via fMRI and EEG, assessed after 3 months, after 6 months and after 3 months follow-up. Changes in brain volume assessed via MRI, assessed after 3 months, after 6 months and after 3 months follow-up. | — |
Countries
Germany
Contacts
Public ContactMaria Buthut
Charité - Universitätsmedizin Berlin
Outcome results
None listed