Multimodal Imaging in the Study of Disorientation in the Hospital

NCT ID: NCT04387357

Last Updated: 2020-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Mild Cognitive Impairment Dementia Disorientation Older Adults Magnetic Resonance Imaging

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Neurologically healthy older adults above the age of 50

No interventions assigned to this group

Experimental

Older adults above the age of 50 with Mild Cognitive Impairment or Dementia

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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German Center for Neurodegenerative Diseases (DZNE)

OTHER

Sponsor Role collaborator

University Medical Center Rostock

OTHER

Sponsor Role lead

Responsible Party

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Stefan Teipel

Prof. Dr. med

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan J. Teipel, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Rostock

Locations

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Clinic and Polyclinic for Psychosomatics and Psychotherapeutic Medicine, University Medical Center Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Chimezie O Amaefule, M.Sc

Role: CONTACT

0049-381-494-9478

Facility Contacts

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Stefan J. Teipel, Prof. Dr.

Role: primary

0049-381-494-9471

References

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Schaat S, Koldrack P, Yordanova K, Kirste T, Teipel S. Real-Time Detection of Spatial Disorientation in Persons with Mild Cognitive Impairment and Dementia. Gerontology. 2020;66(1):85-94. doi: 10.1159/000500971. Epub 2019 Jul 30.

Reference Type BACKGROUND
PMID: 31362286 (View on PubMed)

Ranasinghe KG, Hinkley LB, Beagle AJ, Mizuiri D, Dowling AF, Honma SM, Finucane MM, Scherling C, Miller BL, Nagarajan SS, Vossel KA. Regional functional connectivity predicts distinct cognitive impairments in Alzheimer's disease spectrum. Neuroimage Clin. 2014 Jul 23;5:385-95. doi: 10.1016/j.nicl.2014.07.006. eCollection 2014.

Reference Type BACKGROUND
PMID: 25180158 (View on PubMed)

Other Identifiers

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A-2012-0083

Identifier Type: -

Identifier Source: org_study_id

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