Multimodal Imaging in the Study of Disorientation in the Hospital

• Conditions: Older Adults; Magnetic Resonance Imaging; Mild Cognitive Impairment; Disorientation; Dementia

• Registration Number: NCT04387357
• Lead Sponsor: University Medical Center Rostock

Brief Summary

The purpose of this study is to investigate whether markers of brain structure and function from MRI are associated with different levels of spatial orientation and gait parameters in people with mild cognitive impairment or dementia due to Alzheimer's disease when walking through a real world environment.

Detailed Description

This is an experimental cross-sectional study which primarily aims at identifying characteristic features of spatial disorientation among people with mild cognitive impairment and dementia. The features of interest are motion and physiological related changes that occur during instances of spatial disorientation, which will be derived from wearable sensors.

Additionally, brain structure and functional connectivity changes associated with different levels of spatial orientation and gait parameters will also be investigated through resting-state functional imaging.

Study Timeline

• Study Start: 2019-10-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-12
• Last Update Submitted: 2020-05-12
• Study First Posted: 2020-05-13
• Last Update Posted: 2020-05-13
• Primary Completion: 2021-06
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 50 years and above
• Mini mental state examination (MMSE) ≥ 12 < 28 points for experimental group
• Mini mental state examination (MMSE) ≥ 28 points for control group
• Sufficient knowledge of German to understand participant information, declaration of consent and questionnaires
• Dated and signed declaration of consent
• Sufficient mobility and motivation to participate in the study

Exclusion Criteria

• Less than 50 years
• Significantly impaired vision or hearing
• Severely reduced mobility: cannot move around independently (even with aids)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spatial disorientation	Up to 3 years from start of the study	Incidences of disorientation will be annotated in real-time using a customized annotation scheme in the pocket observer software

Secondary Outcome Measures

Name	Time	Method
Heart rate variability	Up to 3 years from start of the study	Rate of change in heart rate will be measured using a wearable Photoplethysmography sensor
Skin conductance	Up to 3 years from start of the study	Rate of change in electrodermal response will be measured using a wearable electrodermal activity sensor
Accelerometry	Up to 3 years from start of the study	Incidences of change in movement behaviour and activity level will be measured using accelerometers
Grey matter volume	Up to 3 years from start of the study	Rate of change in brain structural volume will be measured using a 3-Tesla scanner
White matter integrity	Up to 3 years from start of the study	Rate of change in structural connectivity of brain white matter will be measured using a 3-Tesla scanner
Resting-state functional connectivity	Up to 3 years from start of the study	Rate of change in functional connectivity of resting-state brain networks will be measured using a 3-Tesla scanner
Interview responses	Up to 3 years from start of the study	Participants assessments of their sense of orientation are obtained using a structured interview.

Trial Locations

Locations (1)

Clinic and Polyclinic for Psychosomatics and Psychotherapeutic Medicine, University Medical Center Rostock; 🇩🇪 Rostock, Mecklenburg-Western Pomerania, Germany