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Multimodal Imaging in the Study of Disorientation in the Hospital

Multimodal Imaging in Alzheimer's Disease and Other Neurodegenerative Diseases

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04387357
Enrollment
50
Registered
2020-05-13
Start date
2019-10-01
Completion date
2021-06-30
Last updated
2020-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Disorientation, Magnetic Resonance Imaging, Mild Cognitive Impairment, Older Adults

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.

Interventions

None listed

Sponsors

German Center for Neurodegenerative Diseases (DZNE)
CollaboratorOTHER
University Medical Center Rostock
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Spatial disorientationUp to 3 years from start of the studyIncidences of disorientation will be annotated in real-time using a customized annotation scheme in the pocket observer software

Secondary

MeasureTime frameDescription
Skin conductanceUp to 3 years from start of the studyRate of change in electrodermal response will be measured using a wearable electrodermal activity sensor
AccelerometryUp to 3 years from start of the studyIncidences of change in movement behaviour and activity level will be measured using accelerometers
Grey matter volumeUp to 3 years from start of the studyRate of change in brain structural volume will be measured using a 3-Tesla scanner
Heart rate variabilityUp to 3 years from start of the studyRate of change in heart rate will be measured using a wearable Photoplethysmography sensor
Resting-state functional connectivityUp to 3 years from start of the studyRate of change in functional connectivity of resting-state brain networks will be measured using a 3-Tesla scanner
Interview responsesUp to 3 years from start of the studyParticipants assessments of their sense of orientation are obtained using a structured interview.
White matter integrityUp to 3 years from start of the studyRate of change in structural connectivity of brain white matter will be measured using a 3-Tesla scanner

Countries

Germany

Contacts

Primary ContactChimezie O Amaefule, M.Sc
chimezie.amaefule@dzne.de0049-381-494-9478

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026