Multimodal Imaging in the Study of Disorientation in the Hospital

May 12, 2020 updated by: Stefan Teipel, University Medical Center Rostock

Multimodal Imaging in Alzheimer's Disease and Other Neurodegenerative Diseases

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Mecklenburg-Western Pomerania
      • Rostock, Mecklenburg-Western Pomerania, Germany, 18147
        • Recruiting
        • Clinic and Polyclinic for Psychosomatics and Psychotherapeutic Medicine, University Medical Center Rostock
        • Contact:
        • Principal Investigator:
          • Stefan J. Teipel, Prof. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy older adults and older adults with mild cognitive impairment or dementia

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Control
Neurologically healthy older adults above the age of 50
Experimental
Older adults above the age of 50 with Mild Cognitive Impairment or Dementia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spatial disorientation
Time Frame: 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
Up to 3 years from start of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin conductance
Time Frame: Up to 3 years from start of the study
Rate of change in electrodermal response will be measured using a wearable electrodermal activity sensor
Up to 3 years from start of the study
Heart rate variability
Time Frame: Up to 3 years from start of the study
Rate of change in heart rate will be measured using a wearable Photoplethysmography sensor
Up to 3 years from start of the study
Accelerometry
Time Frame: Up to 3 years from start of the study
Incidences of change in movement behaviour and activity level will be measured using accelerometers
Up to 3 years from start of the study
Grey matter volume
Time Frame: Up to 3 years from start of the study
Rate of change in brain structural volume will be measured using a 3-Tesla scanner
Up to 3 years from start of the study
White matter integrity
Time Frame: 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
Up to 3 years from start of the study
Resting-state functional connectivity
Time Frame: 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
Up to 3 years from start of the study
Interview responses
Time Frame: Up to 3 years from start of the study
Participants assessments of their sense of orientation are obtained using a structured interview.
Up to 3 years from start of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Rostock

Collaborators

German Center for Neurodegenerative Diseases (DZNE)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 13, 2020

Study Record Updates

Last Update Posted (Actual)

May 13, 2020

Last Update Submitted That Met QC Criteria

May 12, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-2012-0083

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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