Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT03910010

Brain Imaging Study on Biomarkers for Fibromyalgia

Led by Nova Scotia Health Authority · Updated on 2024-08-22

35

Participants Needed

1

Research Sites

726 weeks

Total Duration

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AI-Summary

What this Trial Is About

Drugs used for managing Fibromyalgia pain have not proven to be effective and pain continues to cost Canadians $60 billion a year without truly helping those who suffer. The study proposes to investigate the factors related to a person that can enhance or reduce the effectiveness of pain treatments in people suffering with Fibromyalgia pain. Treatment response to painkillers in a person may be related to their brain, social, and psychological makeup. The investigators aim to study these factors to identify and develop feasible and robust indicators based on a person's biological makeup (also called biomarkers). These biomarkers will allow doctors and researchers to predict more accurately which treatment and prevention strategies for a particular disease will work in which groups of people. These measures will offer new opportunities for improving treatment such as by tailoring treatment to meet the specific needs of each patient based on his/her biological and psychological makeup. Towards the specific aim, data will first be collected in several experimental domains for studying treatment expectations (cognitive, psychosocial, brain-related). These 'experimental' data will be compared between Fibromyalgia (FM) and healthy participants to yield new understanding of the factors that govern treatment response. At the end of experimental data collection, the investigators will collect data in the 'clinical' domain. Hence, at the end of the experimental sessions, a subset of FM participants will receive a mock drug (placebo disguised as an approved pain treatment) and another subset will provide pain ratings only and hence serve as a waiting list control for the placebo trial. Data will be studied in steps to understand factors that mediate treatment outcomes and finally the investigators will use advanced computational tools used for big data analysis and aim to identify factors that can be used as biomarkers and precision medicine tools.

CONDITIONS

Official Title

Brain Imaging Study on Biomarkers for Fibromyalgia

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • Right-handed
  • For chronic pain participants: chronic low back pain lasting more than 6 months
  • For chronic pain participants: average clinical pain at least 4 out of 10 in the two weeks before enrollment
  • Comfortable reading and writing English to complete questionnaires and tasks
  • For healthy participants: age between 18 and 75 years
  • For healthy participants: right-handed
  • For healthy participants: comfortable reading and writing English to complete questionnaires and tasks
Not Eligible

You will not qualify if you...

  • History of cardiac, respiratory, or nervous system diseases that may interfere with participation or increase risk, such as asthma or claustrophobia
  • Any contraindications to MRI scanning, including cardiac pacemaker, metal implants, fear of closed spaces, or pregnancy
  • For healthy participants: any acute or chronic pain

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada, B3h1V7

Actively Recruiting

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Research Team

J

Javeria A Hashmi, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

3

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