NCT04134806

Brief Summary

The aim of the study is to investigate whether the effect of disorientation on physical motion and gait among dementia patients, can be reliably measured in a laboratory environment, by means of a virtual reality (VR) experimental setup.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

2.8 years

First QC Date

October 18, 2019

Last Update Submit

May 7, 2020

Conditions

Mild Cognitive ImpairmentMild DementiaDisorientationYoung AdultsOlder Adults

Outcome Measures

Primary Outcomes (1)

  • Spatial disorientation

    Incidences of disorientation will be captured in a video record during the experiment, and then later identified in an off-line annotation procedure using a customized annotation scheme

    Up to 3 years from start of the study

Secondary Outcomes (9)

  • Gait variability

    Up to 3 years from start of the study

  • Spatial orientation ability

    Up to 3 years from start of the study

  • Heart rate variability

    Up to 3 years from start of the study

  • Skin conductance

    Up to 3 years from start of the study

  • Accelerometery

    Up to 3 years from start of the study

  • +4 more secondary outcomes

Study Arms (3)

Young Adults

Neurologically healthy young adults between ages 18 and 40

Older Adults

Neurologically healthy older adults between ages 60 and 85

Mild Cognitive Impairment/Mild Dementia

Older adults between ages 60 and 85 with Mild Cognitive Impairment or Mild Dementia

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy young adults, healthy older adults and older adults with mild cognitive impairment or mild dementia

You may qualify if:

  • Within the required age bracket
  • Mobile
  • Dementia

You may not qualify if:

  • Other neurological conditions besides dementia
  • Inability to understand task instructions, deaf-mute, blindness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Rostock, Mecklenburg-Vorpommern, 18147, Germany

RECRUITING

Related Publications (3)

  • 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.

    PMID: 31362286BACKGROUND

  • Yordanova K, Koldrack P, Heine C, Henkel R, Martin M, Teipel S, Kirste T. Situation Model for Situation-Aware Assistance of Dementia Patients in Outdoor Mobility. J Alzheimers Dis. 2017;60(4):1461-1476. doi: 10.3233/JAD-170105.

    PMID: 29060937BACKGROUND

  • Amaefule CO, Ludtke S, Kirste T, Teipel SJ. Effect of Spatial Disorientation in a Virtual Environment on Gait and Vital Features in Patients with Dementia: Pilot Single-Blind Randomized Control Trial. JMIR Serious Games. 2020 Oct 8;8(4):e18455. doi: 10.2196/18455.

    PMID: 33030436DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

7.5 millilitre blood sample for Apolipoprotein E4 (ApoE4) analysis

MeSH Terms

Conditions

Cognitive DysfunctionConfusion

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stefan J. Teipel, Prof. Dr.

    University Medical Center Rostock

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chimezie O. Amaefule, M.Sc

CONTACT

0049-381-494-9478chimezie.amaefule@dzne.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

October 18, 2019

First Posted

October 22, 2019

Study Start

March 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 8, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)