Validation of a Novel Cortical Biomarker Signature for Pain

NCT04241562 | Completed DMC

• 1 other identifier: 1R61NS113269-01
• Study Type: observational
• Target: 159
• Locations: 2 countries
• Sites: 2

Brief Summary

The study aims to undertake analytical validation of an brain biomarker in healthy participants experiencing a model of sustained temporomandibular pain. The biomarker could detect participants at greater risk of developing more severe pain.

Conditions

TMD

Outcome Measures

Primary Outcomes (1)

• Peak pain intensity from diary ratings

  Pain sensitivity

  0 to 30 days following NGF injection

Secondary Outcomes (2)

• Average Peak daily pain intensity from from diary ratings

  0 to 30 days following NGF injection

• The time between pain onset and complete resolution of pain for two consecutive days

  0 to 30 days following NGF injection

Interventions

Injection of Nerve Growth Factor OTHER

Injection of Nerve Growth Factor to the right masseter

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy men and women with no medical complaints, no history of chronic pain and no current acute pain between the ages of 18 and 44 years will be included.

You may qualify if:

• healthy

You may not qualify if:

• unable or refusal to provide written consent
• presence of any acute pain disorder
• history or presence of any chronic pain disorder
• history or presence of any other medical or psychiatric compliant
• use of opioids or illicit drugs in the past 3 months
• pregnant or lactating women
• excessive alcohol use
• contraindicated for TMS (metal implants, epilepsy)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Neuroscience Research Australia: collaborator

Study Sites (2)

University of Maryland School of Dentistry

Baltimore, Maryland, 21201, United States

Location

Neuroscience Research Australia

Sydney, New South Wales, 2031, Australia

Location

Related Publications (1)

• Seminowicz DA, Bilska K, Chowdhury NS, Skippen P, Millard SK, Chiang AKI, Chen S, Furman AJ, Schabrun SM. A novel cortical biomarker signature for predicting pain sensitivity: protocol for the PREDICT longitudinal analytical validation study. Pain Rep. 2020 Jul 27;5(4):e833. doi: 10.1097/PR9.0000000000000833. eCollection 2020 Jul-Aug.

  PMID: 32766469 DERIVED

Study Officials

• David A Seminowicz, PhD

  University of Maryland School of Dentistry

  PRINCIPAL INVESTIGATOR

• Siobhan M Schabrun, PhD

  Neuroscience Research Australia; University of New South Wales

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: November 4, 2020
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

AU (1); US (1)