Feasibility - Infinitome

Completed

• Conditions: Alzheimer Disease
• Interventions: Procedure: Infinitome

• Registration Number: NCT04563767
• Lead Sponsor: HealthPartners Institute

Brief Summary

The Infinitome Program from Omniscient has the ability to identify abnormal brain networks or connectomes using resting state functional MRI (rs-fMRI). This technology, which visualizes brain networks in three dimensions, was originally developed to ensure neurosurgeons avoid inadvertently lesioning cognitively eloquent brain regions during surgical operations. The potential of Infinitome in identifying connectome dysfunction for neurodegenerative diseases such as Alzheimer's disease has yet to be explored. This diagnostic technique may play a critical role for identifying disease brain networks that may benefit from targeted interventions in clinical trials.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09-15
• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-24
• Primary Completion: 2020-10-13
• Study Completion: 2020-10-13
• Results First Submitted: 2021-01-22
• Results First Submitted QC: 2021-02-09
• Last Update Submitted: 2021-02-09
• Results First Posted: 2021-02-17
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1. Patients with a diagnosis of mild, moderate, or severe Alzheimer's disease
2. Age: 40 - 90 Years
3. Patients who are clinically indicated for an MRI

Exclusion Criteria

1. fMRI contraindicated (eg. Implantable device, pacemaker, metallic implants, etc.)
2. Subject unable to tolerate sitting for a one hour fMRI
3. Other concerns as determined by the investigator

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infinitome	Infinitome	All patients will be in the same cohort. No intervention will be administered. Patients will undergo a structural magnetic resonance imaging (MRI) as part of their standard of care. Added on will be the resting state fMRI (rs-fMRI). The rs-fMRI data will be analyzed.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Whose Images Completed Analysis	4 months	Percent of subjects whose images were uploaded and analyzed by the Infinitome program. Range: 0-100. Higher percentage indicates more completion.
Number of Participants Who Completed Rs-fMRI	4 months	Percent of subjects who complete the sequence of the fMRI protocol. Range: 0-100. Higher percentage indicates more completion.

Trial Locations

Locations (1)

HealthPartners Neuroscience Center; 🇺🇸 Saint Paul, Minnesota, United States