Feasibility - Infinitome

NCT04563767 | Completed Results

• 1 other identifier: A20-199
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Completed Rs-fMRI

  Percent of subjects who complete the sequence of the fMRI protocol. Range: 0-100. Higher percentage indicates more completion.

  4 months

• Number of Subjects Whose Images Completed Analysis

  Percent of subjects whose images were uploaded and analyzed by the Infinitome program. Range: 0-100. Higher percentage indicates more completion.

  4 months

Study Arms (1)

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.

Procedure: Infinitome

Interventions

Infinitome PROCEDURE

Added sequence of rs-fMRI.

Infinitome

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HealthPartners Neurology Clinic in Saint Paul, MN undergoing care for Alzheimer's disease.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Michael Rosenbloom, MD
• Organization: HealthPartners Neurology

michael.h.rosenbloom@healthpartners.com

651-495-6363

Study Officials

• Michael H Rosenbloom, MD

  HealthPartners Neurology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 24, 2020
• Study Start: September 15, 2020
• Primary Completion: October 13, 2020
• Study Completion: October 13, 2020
• Last Updated: February 17, 2021
• Results First Posted: February 17, 2021

Record last verified: 2020-09

Locations

US (1)