Brain Stimulation for Neurological Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Storz Medical AG
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Corrected Total Score
Study Overview
Brief Summary
This is a prospective double-blind randomized placebo-controlled crossover clinical trial
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinically stable patients with probable Alzheimer's Disease (Diagnosis according to ICD-10 Criteria (F00))
- •At least 3 months of stable antidementive therapy or no antidementive therapy necessary
- •Signed written informed consent
- •Monthly pregnancy test for women in childbearing years
- •Age >= 18 years
Exclusion Criteria
- •Non-compliance with the protocol
- •Pregnant or breastfeeding women
- •Relevant intracerebral pathology unrelated to the Alzheimers's disease (e.g. Brain tumor)
- •Hemophilia or other blood clotting disorders
- •Cortisone treatment within the last 6 weeks before first treatment
- •Thrombosis
Outcomes
Primary Outcomes
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Corrected Total Score
Time Frame: month 3
CERAD stands for "The Consortium to Establish a Registry for Alzheimer's Disease". The CERAD was funded by the National Institute on Aging in 1986 to develop standardized, validated measures for the assessment of Alzheimer's disease (Fillenbaum 2008). CERAD is a cognitive test battery which is normalized for age, gender and education (Morris 1988). The CERAD total score (Chandler 2005) is a good measure for Alzheimer's Disease (Ehrensperger 2010, Rossetti 2010, Seo 2010, Hallikainen 2013). The CERAD total score is a scale from 0 to 100 with 100 meaning "normal cognitive ability" and 0 meaning "severe cognitive impairment".
Secondary Outcomes
- Alzheimer's Disease Assessment Scale (ADAS)(month 3)
- Instrumental Activities of Daily Living Scale (IADL) - Patient(immediately post-treatment)
- Leisure Behavior (FZV; German: Freizeitverhalten)([ Time Frame: month 3 ])
- CERAD(month 3)
- Neuropsychiatric Inventory (NPI) (Care Taker)(month 3)
- Bayer Activities of Daily Living Scale (B-ADL)([ Time Frame: month 3 ])
- Geriatric Depression Scale - short form (GDS-15)([ Time Frame: month 3 ])
- anatomical Magnetic Resonance Imaging (MRI)(immediately post-treatment)
- functional Magnetic Resonance Imaging (fMRI)(immediately post-treatment)
- Neuropsychological Test Battery Vienna (NTBV)(month 3)
- Beck Depression Inventory (BDI)(month 3)
- IADL (Care Taker)(month 3)
- Clock drawing test(month 3)
- IADL- Patient(month 3)
- Forgetfulness assessment inventory (FAI)(month 3)
- Prosopagnosia index (PI20)(month 3)