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OpenTrials
Completed

NCT Number: NCT04241562

Validation of a Novel Cortical Biomarker Signature for Pain

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.

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Key information

Conditions

TMD

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Neuroscience Research Australia, Sydney, New South Wales, Australia

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Injection of Nerve Growth Factor

Other

Injection of Nerve Growth Factor to the right masseter

Primary outcomes

  1. Peak pain intensity from diary ratings

    Time frame: 0 to 30 days following NGF injection

    Pain sensitivity

Secondary outcomes

  1. Average Peak daily pain intensity from from diary ratings

    Time frame: 0 to 30 days following NGF injection

    Pain severity

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

    Time frame: 0 to 30 days following NGF injection

    Pain duration

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • Neuroscience Research Australia

Registry information

Acronym: PREDICT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2020
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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