Recruiting

Diffusion MRI

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06892041

Conditions

Masticatory Myofascial Pain Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Study Details

Brief summary:

The purpose of this study is to assess the diagnostic accuracy of diffusion MRI for evaluation of the jaw muscles for patients with masticatory myofascial pain syndrome.

Conditions

Masticatory Myofascial Pain Syndrome

Study ID

NCT06892041

Start date

Sep 4, 2025

Status verified date

Sep, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Men and women 18-65 years of age
  • Ability to give informed consent
  • Symptoms meeting criteria for normal or latent/active temporomandibular myofascial pain

Exclusion Criteria:

  • Contraindications to MRI scanning including severe obesity or difficulty in laying in a supine position, 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 or breast feeding
  • Traumatic injury of masticatory muscles or temporomandibular joint within last 12 months
  • Mandibular fracture within last 12 months
  • Initiation of additional treatment of myofascial pain within the past 1 month
  • Received masseter Botox within the last 4 months

Study Design

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

Normal

Subjects without masticatory myofascial pain syndrome

Latent/Active Pain Stage

Subjects with latent or active masticatory myofascial pain syndrome

Primary outcome measure

  • Difference in mean diffusion MRI parameters of temporalis and masseter muscles between patients at the normal stage and those at the latent/active pain stage. [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Elizabeth Lane

646-962-8394ell2032@med.cornell.edu

Locations

New York University

Recruiting

New York, New York, United States, 10016

Contacts

Nalini Jeet

212-263-0228Nalini.Jeet@nyulangone.org

Principal Investigator:

Els Fieremans

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Elizabeth Lane

646-962-8394ell2032@med.cornell.edu

Principal Investigator:

Gene Kim, PhD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Oct 1, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2025-10-01.