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Multimodal Imaging in the Study of Disorientation in the Hospital

U

University Medical Center Rostock

Status

Unknown

Conditions

Disorientation
Mild Cognitive Impairment
Older Adults
Dementia
Magnetic Resonance Imaging

Study type

Observational

Funder types

Other

Identifiers

NCT04387357
A-2012-0083

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

50 participants in 2 patient groups

Control
Description:
Neurologically healthy older adults above the age of 50
Experimental
Description:
Older adults above the age of 50 with Mild Cognitive Impairment or Dementia

Trial contacts and locations

1

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Central trial contact

Chimezie O Amaefule, M.Sc

Data sourced from clinicaltrials.gov

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