Multimodal Imaging in the Study of Disorientation in the Hospital

• Sponsor: University Medical Center Rostock (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04387357
• Collaborator: German Center for Neurodegenerative Diseases (DZNE) (Other)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 21
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment; Dementia; Disorientation; Older Adults; Magnetic Resonance Imaging

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 Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Multimodal Imaging in Alzheimer's Disease and Other Neurodegenerative Diseases
• Actual Study Start Date: Oct 1, 2019
• Anticipated Primary Completion Date: Jun 1, 2021
• Anticipated Study Completion Date: Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Control Neurologically healthy older adults above the age of 50
Experimental Older adults above the age of 50 with Mild Cognitive Impairment or Dementia

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. Accelerometry [Up to 3 years from start of the study]

   Incidences of change in movement behaviour and activity level will be measured using accelerometers

4. 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

5. 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

6. 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

7. Interview responses [Up to 3 years from start of the study]

   Participants assessments of their sense of orientation are obtained using a structured interview.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinic and Polyclinic for Psychosomatics and Psychotherapeutic Medicine, University Medical Center Rostock	Rostock	Mecklenburg-Western Pomerania	Germany	18147

Sponsors and Collaborators

• University Medical Center Rostock
• German Center for Neurodegenerative Diseases (DZNE)

Investigators

• Principal Investigator: Stefan J. Teipel, Prof. Dr., University Medical Center Rostock

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Stefan Teipel, Prof. Dr. med, University Medical Center Rostock
• ClinicalTrials.gov Identifier: NCT04387357
• Other Study ID Numbers: A-2012-0083
• First Posted: May 13, 2020
• Last Update Posted: May 13, 2020
• Last Verified: May 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Confusion; Cognitive Dysfunction

Study Results

No Results Posted as of May 13, 2020