Validation of a Novel Cortical Biomarker Signature for Pain (PREDICT)

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.

Study Overview

• Status: Completed
• Conditions: TMD
• Intervention / Treatment: Other: Injection of Nerve Growth Factor

Detailed Description

Chronic pain is a major health burden associated with immense economic and social costs. Predictive biomarkers that can identify individuals at risk of developing severe and persistent pain, which is associated with worse disability and greater reliance on opioids, would promote aggressive, early intervention that could halt the transition to chronic pain. The investigative team has uncovered evidence of a unique cortical biomarker signature that predicts pain susceptibility (severity and duration). The biomarker signature combines resting state sensorimotor peak alpha frequency (PAF) measured using electroencephalograph (EEG) and corticomotor excitability (CME) measured using transcranial magnetic stimulation (TMS). This PAF/CME biomarker signature could be capable of predicting the severity of pain experienced by an individual minutes to months in the future, as well as the duration of pain (time to recovery). In the current study, the investigators aim to undertake analytical validation of this biomarker in healthy participants using a standardized model of the transition to sustained myofascial temporomandibular pain (masseter intramuscular injection of nerve growth factor). The investigators will record PAF/CME at multiple time points before and during the development of pain and use online diaries and in-laboratory assessments of pain, sleep, stress, and other psychosocial variables. Specifically, the investigators will test if the biomarker signature predicts an individual's pain sensitivity (high- or low-pain sensitive).

• Study Type: Observational
• Enrollment (Actual): 159

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2031
      • Neuroscience Research Australia
• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• healthy

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak pain intensity from diary ratings	Pain sensitivity	0 to 30 days following NGF injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Peak daily pain intensity from from diary ratings	Pain severity	0 to 30 days following NGF injection
The time between pain onset and complete resolution of pain for two consecutive days	Pain duration	0 to 30 days following NGF injection

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: Neuroscience Research Australia
• Investigators: Principal Investigator: David A Seminowicz, PhD, University of Maryland School of Dentistry; Principal Investigator: Siobhan M Schabrun, PhD, Neuroscience Research Australia; University of New South Wales

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2020
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): October 10, 2022

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: 1R61NS113269-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified, individual participant data will be made available immediately following publication via an open-access data repository.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No