NCT03910010 Brain Imaging Study on Biomarkers for Fibromyalgia
| NCT ID | NCT03910010 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nova Scotia Health Authority |
| Condition | Fibromyalgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2021-02-01 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2021-02-01 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Chronic pain participant inclusion criteria: 1. 18-75 years of age 2. Right-handed 3. Meet the classification criteria of chronic low back pain (having low back pain for more than 6 months). 4. At least 4/10 clinical pain on the Brief Pain Inventory Scale on average during the two weeks prior to enrollment 5. Comfortable completing (reading and writing) questionnaires and tasks with English language instructions Healthy participant inclusion criteria: 1. 18 - 75 years of age 2. Right-handed 3. Comfortable completing (reading and writing) questionnaires and tasks with English language instructions Exclusion Criteria: Chronic pain participant exclusion criteria: 1. 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 2. Presence of any contraindications to MRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy Healthy participant exclusion criteria: 1. Acute or chronic pain 2. 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 3. Presence of any contraindications to MRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03910010 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Fibromyalgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03910010 currently recruiting?
Yes, NCT03910010 is actively recruiting participants. Contact the research team at javeria.hashmi@dal.ca for enrollment information.
Where is the NCT03910010 trial being conducted?
This trial is being conducted at Halifax, Canada.
Who is sponsoring the NCT03910010 clinical trial?
NCT03910010 is sponsored by Nova Scotia Health Authority. The trial plans to enroll 35 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.