Teleneurology Assessment Program for Creutzfeldt-Jakob Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospitals Cleveland Medical Center
About this trial
This observational study uses secure videoconference visits to follow people with Creuztzfeldt-Jakob disease (CJD) over time. The study collects information about participants' symptoms, neurological function, thinking and memory, and ability to perform daily activities. It also collects information from study partners about the participant and about their own well-being and experiences as caregivers. The goal of the study is to better understand how CJD changes over time and to evaluate the use of remote assessments for CJD research and surveillance.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age greater than 18 years.
Participant must have a study partner who will be present with the participant for all videoconference evaluations (in the same physical location).
Participant meets criteria for definite or probable prion disease or is a known PRNP mutation carrier with active disease.
Participant and/or appropriate proxy consents to study participation.
Disqualifiers
Participant's diagnosis is most likely not prion disease.
Participant or study partner is less than 18 years of age.
Participant or study partner does not have internet access or a computer, smartphone, or tablet with videoconference capabilities.
Participant does not have a study partner.
Trial population
Adults with definite or probable prion disease, or known PRNP mutation carriers with active disease, who are referred to TAPCJD and meet study eligibility criteria. Each participant must have an adult study partner who knows the participant well, has regular contact with them, and is present for the videoconference assessments.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Teleneurology Assessment
Other interventionParticipants undergo standardized videoconference-based assessments of clinical history, cognitive function, neurological function, functional status, and neuropsychiatric symptoms. Study partners provide information about the participant and complete caregiver well-being and burden assessments.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Prion Disease1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants who complete a Teleneurology Assessment
The number of participants who complete at least on standardized teleneurology assessment by videoconference will be recorded
Time frame
Baseline through end of participant follow-up, up to 10 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospitals Cleveland Medical Center
Lead sponsor
Case Western Reserve University
Collaborator
CJD Foundation
Collaborator
Source ClinicalTrials.gov