Validation of a Novel Cortical Biomarker Signature for Pain

  • STATUS
    Recruiting
  • participants needed
    150
  • sponsor
    University of Maryland, Baltimore
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Updated on 16 February 2024
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nerve growth factor
ache

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.

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).

Details
Condition TEMPOROMANDIBULAR JOINT DISORDER, Costen's Syndrome
Age 18years - 44years
Treatment Injection of Nerve Growth Factor
Clinical Study IdentifierNCT04241562
SponsorUniversity of Maryland, Baltimore
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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)
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