Clinical trial NCT04241562: Validation of a Novel Cortical Biomarker Signature for Pain
Official title: Validation of a Novel Cortical Biomarker Signature for Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: TMD
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Neuroscience Research Australia
First posted: 2020-01-27
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Peak pain intensity from diary ratings
timeFrame: 0 to 30 days following NGF injection
Secondary outcomes:
measure: Average Peak daily pain intensity from from diary ratings
timeFrame: 0 to 30 days following NGF injection
measure: The time between pain onset and complete resolution of pain for two consecutive days
timeFrame: 0 to 30 days following NGF injection
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland School of Dentistry
state: Maryland
city: Sydney
country: Australia
facility: Neuroscience Research Australia
state: New South Wales
Study officials:
affiliation: University of Maryland School of Dentistry
name: David A Seminowicz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neuroscience Research Australia; University of New South Wales
name: Siobhan M Schabrun, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.