Non-invasive, Wearable Multi-parameter System for the Early Prediction of Cognitive Decline and Dementia in Older Adults

NCT04262674 | Unknown

• 1 other identifier: 5213.00187
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This project develops an innovative screening system and prediction model to detect preclinical symptoms of cognitive impairment and predict the potential development of mild cognitive impairments and dementia in older adults. The earliest possible detection of preclinical symptoms is prerequisite to improve the efficacy of subsequent preventative non-pharmacological, life-style and exercise related, personalized treatment interventions.

Conditions

Mild Cognitive Impairment; Healthy Aging

Outcome Measures

Primary Outcomes (6)

• Electroencephalography (EEG)

  EEG frequency bands (Hz) will be assessed during 10 minutes at rest in a seated position (5 min eyes closed, 5 min eyes open) and will be recorded using a wearable system covering the frontal, parietal, temporal, and occipital cortex and integrating 20 gel-pad electrode channels. The assessment will be continued during the subsequent gait protocol which consists of 8 minutes of walking back and forth at preferred speed on a 20 m track.

  30 minutes

• Gait speed analysis with inertial sensors

  The gait protocol consists of 8 minutes of walking back and forth at preferred speed on a 20 m track. Thereby, walking speed (m/s) will be assessed using inertial sensors attached to the feet.

  15 minutes

• Gait variability analysis with inertial sensors

  The gait protocol consists of 8 minutes of walking back and forth at preferred speed on a 20 m track. Thereby, step length variability (%) and step time variability (%) will be assessed using inertial sensors attached to the feet.

  15 minutes

• Heart rate variability (HRV) indices SDNN and RMSSD with two-lead electrocardiogram chest belt

  The HRV indices SDNN (ms) and RMSSD (ms) will be assessed during 10 minutes in a seated position, using a two-lead electrocardiogram chest belt.

  10 minutes

• Heart rate variability (HRV) index HF power with two-lead electrocardiogram chest belt

  The HRV index HF power (ms\^2) will be assessed during 10 minutes in a seated position, using a two-lead electrocardiogram chest belt.

  10 minutes

• Body temperature (T) with temperature sensors (thermistors)

  T will be assessed under controlled climatic conditions (22°C/40% relative humidity) measuring skin T (°C) at the scapula and the the ribs (lateral) using temperature sensors (thermistors) during 10 minutes sitting and 8 minutes walking as described above.

  30 minutes

Secondary Outcomes (2)

• Cognitive performance with neuropsychological tests

  1 hour

• Core body temperature (Tc) with telemetric gastrointestinal temperature pill

  16 hours

Study Arms (2)

Cognitive-motor training

EXPERIMENTAL

Simultaneous cognitive-motor training (i.e. exergame) and strength training

Other: Cognitive-motor training

Control

NO INTERVENTION

Passive control group

Interventions

Cognitive-motor training OTHER

Simultaneous cognitive-motor training and strength training

Also known as: Exergame, Step Mania

Cognitive-motor training

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• participants have to be older than 65 years of age
• cognitively healthy or diagnosed with MCI
• able to walk at least 8 minutes for gait analysis, with or without walking aids
• live independently or in a retirement home (classified 0, 1, or 2 within the Swiss classification system for health-care requirements BESA-levels \[German abbreviation for: Bewohner-Einstufungs- und Abrechnungs-System; level 0 meaning the person does not need care or treatment; level 1 to 2 meaning, the person only needs little care or treatment\])
• sign informed consent

You may not qualify if:

• previously diagnosed dementia, e.g. Alzheimer's disease
• recent head injury
• judgment by the participant's primary care physician will be required in the case of acute or instable chronic diseases (e.g. stroke, diabetes) and rapidly progressing or terminal illnesses
• history of operations and/or disease related to the gastrointestinal tract within last 5 years
• implanted medical device
• planned MRI examination
• nausea, vomiting, constipation or abdominal pain within 1 months prior to the day of planned measurement

Sponsors & Collaborators

• Empa, Swiss Federal Laboratories for Materials Science and Technology: lead
• Geriatrische Klinik St. Gallen: collaborator
• ETH Zurich: collaborator

Study Sites (1)

Empa

Sankt Gallen, Canton of St. Gallen, 9014, Switzerland

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Patrick Eggenberger, Dr.

  Empa, Swiss Federal Laboratories for Materials Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Postdoc

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 10, 2020
• Study Start: September 23, 2019
• Primary Completion: May 1, 2021
• Study Completion: July 1, 2021
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

CH (1)