RECRUITING

CoMind Early Feasibility Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around the brain from the outside (this pressure is called intracranial pressure or ICP). Monitoring and managing ICP is an important part of care for patients with conditions such as Traumatic Brain Injury (TBI). However, the current way of measuring ICP requires surgery to drill a hole into the skull, and therefore can introduce additional risks such as infections and pain. Recent research has shown it may be possible to measure ICP without needing surgery. This technology is in development, but large amounts of data is required to build these new devices. Through collecting a large database of information from patients who have both the routine surgical device and the research device applied to their head, the research team will work to develop and test an effective and potentially safer way of monitoring patient ICP.

Official Title

An Early Feasibility Study for the Development of a Model to Non-Invasively Estimate Intracranial Pressure (ICP) and New Metrics of Cerebral Autoregulation (CAR) Using the CoMind One EFS Device

Quick Facts

Study Start:2024-11-27
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06368648

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female sex at birth, and aged 18 years or older on the date of enrollment.
  2. 2. Receiving continuous invasive ICP monitoring (Bolt or EVD) as part of standard care.
  3. 3. Invasive ICP monitor catheter penetrating the parenchyma or ventricles.
  4. 4. Receiving continuous invasive ABP monitoring as part of standard care.
  1. 1. Presence of any implant (cosmetic or otherwise) in the frontal bone in such proximity to the CoMind One EFS Sensor that they might physically touch.
  2. 2. Open wounds on the forehead such that CoMind One EFS Sensor cannot be safely placed over an area of intact skin
  3. 3. Presenting with radiographic evidence of a non-intact skull at the recording site on admission.
  4. 4. If patient is enrolled in an intervention/study that may interfere with SoC ICP measurements or the CoMind One EFS device measurement then the patient is ineligible.
  5. 5. Patients with decompressive craniectomy will be excluded unless a CoMind One EFS recording can be made from intact skull.

Contacts and Locations

Study Contact

David Diedo
CONTACT
+447912 209019
david@comind.io
Rianna Mortimer
CONTACT
+447308 312168
rianna@lindushealth.com

Principal Investigator

Ramani Balu, MD, PhD
PRINCIPAL_INVESTIGATOR
Inova Fairfax Hospital

Study Locations (Sites)

University of Washington, Harborview
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: CoMind Technologies Limited

  • Ramani Balu, MD, PhD, PRINCIPAL_INVESTIGATOR, Inova Fairfax Hospital

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 Registration Dates

Study Start Date2024-11-27
Study Completion Date2025-10

Study Record Updates

Study Start Date2024-11-27
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

  • Intracranial Pressure
  • Traumatic Brain Injury
  • Cerebral Autoregulation

Additional Relevant MeSH Terms

  • Intracranial Pressure
  • Intracranial Pressure Changes
  • Traumatic Brain Injury
  • Intracerebral Hemorrhage
  • Encephalitis
  • Encephalopathy
  • Hydrocephalus
  • Stroke
  • Autoregulation