Validation of a Novel Cortical Biomarker Signature for Pain

TMD Clinical Trial

— PREDICT  

Official title:

Validation of a Novel Cortical Biomarker Signature for Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04241562
• Other study ID #: 1R61NS113269-01
• Status: Completed
• Start date: November 4, 2020
• Est. completion date: October 10, 2022

Study information

• Verified date: April 2023
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: October 10, 2022
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 44 Years

Eligibility

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)

Related Conditions & MeSH terms

• TMD

Intervention

Other:
• Injection of Nerve Growth Factor
Injection of Nerve Growth Factor to the right masseter

Locations

Country	Name	City	State
Australia	Neuroscience Research Australia	Sydney	New South Wales
United States	University of Maryland School of Dentistry	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Neuroscience Research Australia

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak pain intensity from diary ratings	Pain sensitivity	0 to 30 days following NGF injection
Secondary	Average Peak daily pain intensity from from diary ratings	Pain severity	0 to 30 days following NGF injection
Secondary	The time between pain onset and complete resolution of pain for two consecutive days	Pain duration	0 to 30 days following NGF injection