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ADA-auriculoacupuncture as a symptomatic treatment for agitation in people with dementia:a randomized, controlled, rater-blind pilot study

Not Applicable
Conditions
agitation in people with dementia
Registration Number
DRKS00017703
Lead Sponsor
Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum München, LMU München
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
40
Inclusion Criteria

age at least 65 years;
- dementia, diagnosed by a physician;
- clinical agitation in 4 weeks prior to inclusion;
- written consent by the patient if capacity for consent is given or written consent by the authorized proxy if an authorized proxy exists.

Exclusion Criteria

- dermal or chondral ear defects that would prevent an acupuncture treatment;
- anticoagulation with phenprocoumon, warfarine or multiple anticoagulatory treatment;
- elevated risk of bleeding due to coagulatory defects (e.g. hemophilia);
- clinically permanent severe agitation, indicating that an acupuncture treatment might be impossible;
- known physical resistance in needle-involving situations (e.g. blood collection);
- physical resistance of the person during the compliance test (ear disinfection test);
- acupuncture treatment during 4 weeks prior to preliminary medical exam;
- vagal nerve stimulation treatment during 4 weeks prior to preliminary medical exam.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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