Clinical trial NCT03770182: Brain Stimulation for Neurological Patients
Official title: Brain Stimulation for Neurological Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Storz Medical AG
Sponsor class: INDUSTRY
Collaborators: name: Medical University of Vienna
First posted: 2018-12-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a prospective double-blind randomized placebo-controlled crossover clinical trial


Eligibility criteria: 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

Primary outcomes:
measure: Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Corrected Total Score
timeFrame: month 3
Secondary outcomes:
measure: Alzheimer's Disease Assessment Scale (ADAS)
timeFrame: immediately post-treatment
measure: Alzheimer's Disease Assessment Scale (ADAS)
timeFrame: month 1
measure: Alzheimer's Disease Assessment Scale (ADAS)
timeFrame: month 3
measure: Neuropsychological Test Battery Vienna (NTBV)
timeFrame: immediately post-treatment
measure: Neuropsychological Test Battery Vienna (NTBV)
timeFrame: month 1
measure: Neuropsychological Test Battery Vienna (NTBV)
timeFrame: month 3
measure: CERAD
timeFrame: immediately post-treatment
measure: CERAD
timeFrame: month 1
measure: CERAD
timeFrame: month 3
measure: Clock drawing test
timeFrame: immediately post-treatment
measure: Clock drawing test
timeFrame: month 1
measure: Clock drawing test
timeFrame: month 3
measure: Forgetfulness assessment inventory (FAI)
timeFrame: immediately post-treatment
measure: Forgetfulness assessment inventory (FAI)
timeFrame: month 1
measure: Forgetfulness assessment inventory (FAI)
timeFrame: month 3
measure: Instrumental Activities of Daily Living Scale (IADL) - Patient
timeFrame: immediately post-treatment
measure: IADL- Patient
timeFrame: month 1
measure: IADL- Patient
timeFrame: month 3
measure: Beck Depression Inventory (BDI)
timeFrame: immediately post-treatment
measure: Beck Depression Inventory (BDI)
timeFrame: month 1
measure: Beck Depression Inventory (BDI)
timeFrame: month 3
measure: Prosopagnosia index (PI20)
timeFrame: immediately post-treatment
measure: Prosopagnosia index (PI20)
timeFrame: month 1
measure: Prosopagnosia index (PI20)
timeFrame: month 3
measure: Neuropsychiatric Inventory (NPI) (Care Taker)
timeFrame: immediately post-treatment
measure: Neuropsychiatric Inventory (NPI) (Care Taker)
timeFrame: month 1
measure: Neuropsychiatric Inventory (NPI) (Care Taker)
timeFrame: month 3
measure: IADL (Care Taker)
timeFrame: immediately post-treatment
measure: IADL (Care Taker)
timeFrame: month 1
measure: IADL (Care Taker)
timeFrame: month 3
measure: Bayer Activities of Daily Living Scale (B-ADL)
timeFrame: [ Time Frame: immediately post-treatment ]
measure: Bayer Activities of Daily Living Scale (B-ADL)
timeFrame: [ Time Frame: month 1 ]
measure: Bayer Activities of Daily Living Scale (B-ADL)
timeFrame: [ Time Frame: month 3 ]
measure: Geriatric Depression Scale - short form (GDS-15)
timeFrame: [ Time Frame: immediately post-treatment ]
measure: Geriatric Depression Scale - short form (GDS-15)
timeFrame: [ Time Frame: month 1 ]
measure: Geriatric Depression Scale - short form (GDS-15)
timeFrame: [ Time Frame: month 3 ]
measure: Leisure Behavior (FZV; German: Freizeitverhalten)
timeFrame: [ Time Frame: immediately post-treatment ]
measure: Leisure Behavior (FZV; German: Freizeitverhalten)
timeFrame: [ Time Frame: month 1 ]
measure: Leisure Behavior (FZV; German: Freizeitverhalten)
timeFrame: [ Time Frame: month 3 ]
measure: anatomical Magnetic Resonance Imaging (MRI)
timeFrame: immediately post-treatment
measure: functional Magnetic Resonance Imaging (fMRI)
timeFrame: immediately post-treatment
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Roland Beisteiner, Prof.
role: PRINCIPAL_INVESTIGATOR
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