Multimodal Imaging in the Study of Disorientation in the Hospital

Dementia Clinical Trial

Official title:

Multimodal Imaging in Alzheimer's Disease and Other Neurodegenerative Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04387357
• Other study ID #: A-2012-0083
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2020
• Source: University of Rostock
• Contact: Chimezie O Amaefule, M.Sc
• Phone: 0049-381-494-9478
• Email: chimezie.amaefule[@]dzne.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Confusion
• Dementia
• Disorientation
• Magnetic Resonance Imaging
• Mild Cognitive Impairment
• Older Adults

Locations

Country	Name	City	State
Germany	Clinic and Polyclinic for Psychosomatics and Psychotherapeutic Medicine, University Medical Center Rostock	Rostock	Mecklenburg-Western Pomerania

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Rostock	German Center for Neurodegenerative Diseases (DZNE)

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spatial disorientation	Incidences of disorientation will be annotated in real-time using a customized annotation scheme in the pocket observer software	Up to 3 years from start of the study
Secondary	Heart rate variability	Rate of change in heart rate will be measured using a wearable Photoplethysmography sensor	Up to 3 years from start of the study
Secondary	Skin conductance	Rate of change in electrodermal response will be measured using a wearable electrodermal activity sensor	Up to 3 years from start of the study
Secondary	Accelerometry	Incidences of change in movement behaviour and activity level will be measured using accelerometers	Up to 3 years from start of the study
Secondary	Grey matter volume	Rate of change in brain structural volume will be measured using a 3-Tesla scanner	Up to 3 years from start of the study
Secondary	White matter integrity	Rate of change in structural connectivity of brain white matter will be measured using a 3-Tesla scanner	Up to 3 years from start of the study
Secondary	Resting-state functional connectivity	Rate of change in functional connectivity of resting-state brain networks will be measured using a 3-Tesla scanner	Up to 3 years from start of the study
Secondary	Interview responses	Participants assessments of their sense of orientation are obtained using a structured interview.	Up to 3 years from start of the study