pH-weighted MRI in Multiple Sclerosis: A Surrogate Marker of Tissue Metabolic Stress

NCT03028675 | Completed

• 1 other identifier: 16-01434
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Twenty subjects (10 patients and 10 age-matched control volunteers) will be recruited for this study. MRI scans will take place on a 3T MRI Scanner (Skyra or Prisma, Siemens Medical Solutions) located at The NYU Center for Biomedical Imaging. MRI scans will consist of a 1-hour brain scan for both patients and controls. In the first 6 months of the study, investigators will develop and test a uMT-based APT imaging for brain tissue pH measurement and use a hypercapnia paradigm to validate the tissue pH changes between breathing room air and 5% CO2 (by increasing tissue acidity) inhalation. With implementation of hypercapnia MRI, pH-weighted imaging will be validated for its robustness and reproducibility.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• pH measurements

  The pH will be estimated based on the calibration methods of quantification of exchange as a function of saturation time (QUEST)32 and its ratiometric analysis (QUESTRA) 33.

  20 Minutes

Study Arms (2)

Multiple Sclerosis

Other: MRI Scan

Healthy Volunteer

10 age-matched control volunteers

Other: MRI Scan

Interventions

MRI Scan OTHER

MRI scans will consist of a 1-hour brain scan for both patients and controls.

Healthy Volunteer; Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with relapse-remitting multiple sclerosis from NYU Langone Health and age-matched healthy volunteers recruiting using previous database of volunteers

You may qualify if:

• Healthy male or female non-MS control volunteers

You may not qualify if:

• Medically unstable or with cardiac, pulmonary, hematological, renal, or hepatic dysfunction.
• Current or past DSM-IV diagnosis of major depression, bipolar and psychotic disorders.
• Contraindications for MRI, including
• Intracranial clips
• Metal implants
• External metallic devices/objects/clips within 10mm of the head
• Suspected or confirmed metal in the eyes (history of welding or similar activity)
• Claustrophobia
• Cardiac pacemaker or pacing wires
• Pregnancy - Pregnancy tests will be offered to women of childbearing age at no cost to the subject
• History of moderate to severe head injury, stroke, and seizures.
• Alcoholism or drug dependency.
• Renal or liver disease as this may cause concerns related to Gd-DTPA contrast agent.
• Allergy to the contrast agent Gadolinium
• Relapses or steroid therapy in patient at or in the month preceding the study

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Yulin Ge, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 23, 2017
• Study Start: May 1, 2017
• Primary Completion: August 10, 2018
• Study Completion: August 10, 2018
• Last Updated: July 13, 2020

Record last verified: 2020-07

Locations

US (1)