Recruiting

NCT Number: NCT03910010

Brain Imaging Study on Biomarkers for Fibromyalgia

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.

Recruiting

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nova Scotia Health Authority

Halifax, Nova Scotia, B3h1V7, Canada

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Chronic pain participant inclusion criteria:

18-75 years of age
Right-handed
Meet the classification criteria of chronic low back pain (having low back pain for more than 6 months).
At least 4/10 clinical pain on the Brief Pain Inventory Scale on average during the two weeks prior to enrollment
Comfortable completing (reading and writing) questionnaires and tasks with English language instructions

Healthy participant inclusion criteria:

18 - 75 years of age
Right-handed
Comfortable completing (reading and writing) questionnaires and tasks with English language instructions

Exclusion criteria

Chronic pain participant exclusion criteria:

History of cardiac, respiratory, or nervous system disease that may interfere with participation in the study or cause heightened potential for adverse outcome. For example: asthma or claustrophobia
Presence of any contraindications to MRI scanning. For example:

cardiac pacemaker, metal implants, fear of closed spaces, pregnancy

Healthy participant exclusion criteria:

Acute or chronic pain
History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment and by asking the participant about their comfort level and ability, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma or claustrophobia
Presence of any contraindications to MRI scanning. For example:

cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.

Treatment and study plan

Placebos

Drug

Positive treatment expectations will be induced by giving participants capsules containing inert material and telling them that the capsules contain an effective drug that has been approved for treating Chronic Pain. They will be requested to take two capsules four times a day and report their pain on paper forms organized as a calendar or on REDCap.

Primary outcomes

pain modulation- using an experimental task that tests a person's ability to form positive expectations.

Time frame: 3 days after first visit

Brain imaging will be used to assess each participant's capacity to endogenously adjust pain perception with changes in expectations.

Study contacts

Contact information is provided by the study sponsor or research team.

Javeria A Hashmi, PhD

CONTACT

[email protected]

902-473-4603

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2027
Study completion: 2035
First posted: Apr 10, 2019
Registry last updated: Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting