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Validation of a Novel Cortical Biomarker Signature for Pain

Validation of a Novel Cortical Biomarker Signature for Pain

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04241562
Acronym
PREDICT
Enrollment
159
Registered
2020-01-27
Start date
2020-11-04
Completion date
2022-10-10
Last updated
2023-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TMD

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).

Interventions

OTHERInjection of Nerve Growth Factor

Injection of Nerve Growth Factor to the right masseter

Sponsors

Neuroscience Research Australia
CollaboratorOTHER
University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 44 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Peak pain intensity from diary ratings0 to 30 days following NGF injectionPain sensitivity

Secondary

MeasureTime frameDescription
Average Peak daily pain intensity from from diary ratings0 to 30 days following NGF injectionPain severity
The time between pain onset and complete resolution of pain for two consecutive days0 to 30 days following NGF injectionPain duration

Countries

Australia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026