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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04241562
Other study ID # 1R61NS113269-01
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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