Sensor-based systems for early detection of dementia
Organizational Data
- DRKS-ID:
- DRKS00013167
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2018-04-11
- Last update in DRKS:
- 2021-04-12
- Registration type:
- Retrospective
Acronym/abbreviation of the study
SENDA
URL of the study
https://www.tu-chemnitz.de/senda/index.html
Brief summary in lay language
Dementia and cognitive decline are important social problems because of their increasing prevalence in the older population. For an optimal care of the patients it is necessary to detect the illness in an early stage. Pathological changes in the brain can be found in the early stages of the diseases before cognitive symptoms like memory disorders appear. The objective of this project is to examine which factors for in the motor (e.g. gait, balance, fine motoric) and sensory system as well as in brain oscillations are associate with symptoms of dementia. Persons with an age of 80 years and above will be included in this study. They will take part in motor, sensory, neurophysiological and cognitive measurements up to four times within three years.
Brief summary in scientific language
The objective of the SENDA study is to develop a multi-dimensional instrument to detect cognitive decline or dementia with the help of cognitive, sensory, motor and electroencephalogical parameters. The study will examine the following main question: - Which cognitive, sensory, motor and neurophysiological parameters are predictors to differentiate people with subjective cognitive declines or with mild cognitive decline from age-matched healthy people? At the beginning of the study participants will be divided into three groups depending on their cognitive status: 1. cognitive healthy participants, 2. subjectively cognitive impaired participants, 3. participants with mild cognitive impairment. All groups will take part in the same motor, sensory, neurophysiological and cognitive measurements. All measurements will be repeated four times in intervals of eight months to identify associations to cognitive changes over time.
Health condition or problem studied
- Free text:
- older healthy people, Mild Cognitive Impairment (MCI)
- ICD10:
- F06.7 - Mild cognitive disorder
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- At the beginning of the study participants will be divided into three groups depending on their cognitive status: 1. cognitive healthy participants, 2. subjectively cognitive impaired participants, 3. participants with mild cognitive impairment. All measurements will be assessed four times within three years in intervals of eight months to identify associations to cognitive changes over time. One time of measurement consists of 3 examination days. The same motor, sensory, neurophysiological, and cognitive measurements will be conducted for each time of measurement.
Endpoints
- Primary outcome:
- The primary endpoint is to identify motor, sensory, neurophysiological and cognitive parameters to predict cognitive decline or dementia in older people. All measurements will be assessed four times within three years in intervals of eight months to identify associations to cognitive changes over time. One time of measurement consists of 3 examination days. The same motor, sensory, neurophysiological, and cognitive measurements will be conducted for each time of measurement. Measurements, questionnaires: - Montreal Cognitive Assessment, - Consortium to Establish a Registry for Alzheimer`s Disease, - Questionnaire for subjective assessment of mental performance, - Digit Symbol Substitution Test, - gait analysis with OptoGait(R) under single- and dual-task conditions using 3D cameras for video recordings, - Short physical performance battery, - hand force dynamometer, - EEG measurements, - Eriksen flanker task, - fine motor measurements e.g. spontaneous finger tapping, force tracking task, foot coordination, - sensory measurements with shaker or mini-shaker, - Limits of Stability Test, balance tests on the posturomed under single-task and dual-task conditions
- Secondary outcome:
- All measurements will be assessed four times within three years in intervals of eight months to identify associations to cognitive changes over time. One time of measurement consists of 3 examination days. The additional measurements will be conducted for each time of measurement. Therefor, functional, cognitive as well as mental health and lifestyle factors, that might be associated with cognitive decline, will be assessed. These include frailty, comorbidities, social support, quality of life, physical activity, depressive symptoms, and fear of falling. Questionnaires: - Big Five Inventory, - Geriatric depression scale, - Charlson Comorbidity Index, - Questionnaire for social support, - BAECKE inventory for physical activity, - PRISCUS PAQ, - NAI, - FRAIL scale, - Tilburg Frailty Indicator
Study Design
- Purpose:
- Diagnostic
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Doctor's practice Chemnitz und nahe Umgebung
- Other Zeitungsberichte zur Probandenrekrutierung Chemnitz und nahe Umgebung
Recruitment period and number of participants
- Planned study start date:
- 2018-02-01
- Actual study start date:
- 2018-02-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 240
- Final Sample Size:
- 240
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 80 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - Informed consent for study participation, - Basics skills in German language, - Study participant can independently or with the help of an accompanying person visit assessments, - Study participant can walk independently (a walking aid or a rolling walking is aloud)
Exclusion Criteria
- Medically prohibited to be physically active, - Diagnosed psychological disorders as major depression or neurocognitive disorders as dementia - Permanent impairments due to a stroke or a brain surgery, - Other neurological diseases as epilepsy, Parkinson, neuropathy - Severe diseases of the cardiovascular system (e.g., cardiac arrhythmia, arterial occlusive disease, heart failure) - Severe diseases of respiratory system (e.g., COPD stage 4, severe asthma) - Severe diseases of the musculoskeletal system (e.g. arthritis, orthopedic operations in the last 6 months) - Diabetes with diagnosed neuropathy - Substance abuse (delirium) - Difficulties in understanding language or speech - Participant of other clinical studies e.g. for clinical testing of new anti-dementia drugs
Addresses
Primary Sponsor
- Address:
- TU Chemnitz, Human- und Sozialwissenschaftliche Fakultät, Institut für Angewandte Bewegungswissenschaften, Professur Sportpsychologie (mit Schwerpunkt Prävention und Rehabilitation)09126 ChemnitzGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Technische Universität Chemnitz, Fakultät für Human- und Sozialwissenschaften, Institut für Angewandte Bewegungswissenschaften, Professur Sportpsychologie (mit Schwerpunkt Prävention und Rehabilitation)Dr. Katrin MüllerThüringer Weg 1109107 ChemnitzGermany
- Telephone:
- 0049 371 531 33405
- Fax:
- 0049 371 531 832870
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.tu-chemnitz.de/hsw/ab/index.php
Contact for Public Queries
- Address:
- Technische Universität Chemnitz, Fakultät für Human- und Sozialwissenschaften, Institut für Angewandte Bewegungswissenschaften, Professur Sportpsychologie (mit Schwerpunkt Prävention und Rehabilitation)Dr. Katrin MüllerThüringer Weg 1109107 ChemnitzGermany
- Telephone:
- 0049 371 531 33405
- Fax:
- 0049 371 531 832870
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.tu-chemnitz.de/hsw/ab/index.php
Principal Investigator
- Address:
- Technische Universität Chemnitz, Fakultät für Human- und Sozialwissenschaften, Institut für Angewandte Bewegungswissenschaften, Professur Sportpsychologie (mit Schwerpunkt Prävention und Rehabilitation)Dr. Katrin MüllerThüringer Weg 1109107 ChemnitzGermany
- Telephone:
- 0049 371 531 33405
- Fax:
- 0049 371 531 832870
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.tu-chemnitz.de/hsw/ab/index.php
Other contact for scientific queries
- Address:
- Technische Universität Chemnitz, Fakultät für Human- und Sozialwissenschaften, Institut für Angewandte Bewegungswissenschaften, Professur Sportpsychologie (mit Schwerpunkt Prävention und Rehabilitation)Prof. Dr. Claudia Voelcker-RehageThüringer Weg 1109107 ChemnitzGermany
- Telephone:
- 0049 371 531 31889
- Fax:
- 0049 371 531 28619
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.tu-chemnitz.de/hsw/ab/index.php
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Europäischer Sozialfond und der Freistaat Sachsen, Sächsische AufbauBank-Förderbank (SAB)01069 DresdenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Fakultät für Human- und Sozialwissenschaften [Ethikkommission der Fakultät Human- und Sozialwissenschaften der Technischen Universität Chemnitz, 09107 Chemnitz, Deutschland]Wilhelm-Raabe-Straße 4309120 ChemnitzGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.tu-chemnitz.de/hsw/fakultaet/kommissionen/ethik/index.php
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2017-11-07
- Ethics committee number:
- V-232-17-KM-SENDA-07112017
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2017-12-19
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry