Validation of a Novel Cortical Biomarker Signature for Pain

Completed

• Conditions: TMD

• Registration Number: NCT04241562
• Lead Sponsor: University of Maryland, Baltimore

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.

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 Timeline

• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-27
• Study Start: 2020-11-04
• Primary Completion: 2022-10-10
• Study Completion: 2022-10-10
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak pain intensity from diary ratings	0 to 30 days following NGF injection	Pain sensitivity

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University of Maryland School of Dentistry; 🇺🇸 Baltimore, Maryland, United States

Neuroscience Research Australia; 🇦🇺 Sydney, New South Wales, Australia