Neurophysiology of Fibromyalgia

NCT06006130 | Unknown

• 1 other identifier: 16482
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Fibromyalgia is a syndrome associated with fatigue and chronic pain, leading to significant physical limitations and impaired quality of life. There are several challenges that complicate the diagnosis and management of fibromyalgia. The etiology is not well defined, as there are several proposed factors that may trigger the genesis of pain in fibromyalgia including physical and/or emotional life stressors, and genetic predispositions involving neuromodulator pathways. Chronic pain in fibromyalgia arises in the absence of tissue pathology, and consequently a lack of consensus on reliable diagnostic criteria. Understanding the neurophysiology of fibromyalgia would aid in the discovery of objective biomarkers for diagnosis. Therefore, the goals of this study are to:

1. 1.Compare the neurophysiological responses in fibromyalgia compared to healthy controls.
2. 2.Determine whether a two-week rTMS protocol will alter pain in individuals with fibromyalgia.

Conditions

Fibromyalgia

Keywords

fibromyalgia; transcranial magnetic stimulation; neuroplasticity; pain

Outcome Measures

Primary Outcomes (2)

• Change in PROMIS-29 v2.0 Profile

  Using numerical rating (0 to 5) to assess the change in seven health domains including physical function, anxiety, depression, fatigue, sleep disturbances, ability to participate in social roles and activities, and pain interference. Each category consists of 4 questions. Also uses a numerical rating to asses pain intensity (0-10).

  Experiment 1: At baseline pre-intervention, Experiment 2: At baseline pre-intervention and 2 weeks post-intervention

• Change in Fibromyalgia impact questionnaire (FIQ)

  This instrument will be used to assess the patients feeling and emotion related to their pain experience.

  Experiment 1: At baseline pre-intervention, Experiment 2: At baseline pre-intervention and 2 weeks post-intervention

Secondary Outcomes (10)

• Change in Pain catastrophizing scale-EN-SF

  Experiment 1: At baseline pre-intervention, Experiment 2: At baseline pre-intervention and 2 weeks post-intervention

• Change in Patient Health Questionnaire-4 (PHQ-4)

  Experiment 1: At baseline pre-intervention, Experiment 2: At baseline pre-intervention and 2 weeks post-intervention

• Change in Short-form Posttraumatic Checklist-5 (Short-form PCL-5)

  Experiment 1: At baseline pre-intervention, Experiment 2: At baseline pre-intervention and 2 weeks post-intervention

• Change in Motor-evoked potentials (MEPs)

  Experiment 1: At baseline pre-intervention and immediately following 1 treatment session, Experiment 2: At baseline pre-intervention and 2 weeks post-intervention

• Change in Short-Interval Intracortical Inhibition (SICI)

  Experiment 1: At baseline pre-intervention and immediately following 1 treatment session, Experiment 2: At baseline pre-intervention and 2 weeks post-intervention

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

Repetitive Transcranial Magnetic Stimulation (rTMS) will be delivered at 10 Hz, 1500 pulses targeting the hand representation of the left primary motor cortex. rTMS delivery will require \~11 min to complete. In Experiment 1, this intervention will be performed for 1 session (\~11min). In Experiment 2, this intervention will be performed approximately 5 days per week for 2 weeks. In addition, participants will experience their standard medical care.

Device: Active Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham rTMS

SHAM COMPARATOR

Sham rTMS will be delivered at as a placebo control. It is important to note that from the participant perspective, the sham stimulation will feel and sound identical to active rTMS. In Experiment 2, this intervention will be performed approximately 5 days per week for 2 weeks. In addition, participants will experience their standard medical care.

Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

Active Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

rTMS is a non-invasive, non-painful procedure used to relieve chronic pain and promote short-term changes. The abductor pollicis brevis (APB) muscle of the left motor cortex will be targeted using neuronavigation software. 1500 pulses will be delivered at 10 Hz stimulation. Stimulation will be delivered at 80% of the resting motor threshold obtained from the right APB muscle. The delivery of rTMS requires 11 minutes in total.

Active rTMS

Sham Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

A sham coil will be utilized for the sham rTMS condition. It is important to note that from the participant perspective, the sham stimulation will feel and sound identical to active. The location and all other parameters of Sham rTMS will be identical to Active rTMS.

Sham rTMS

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old

You may not qualify if:

• contraindications to TMS
• chronic pain associated with diagnoses other than fibromyalgia

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S4L1, Canada

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Experiment 1: Outcomes assessor will be blinded to the groups (fibromyalgia vs controls) the data is obtained from Experiment 2: Outcomes assessor and participants will be blinded to the intervention group that participants are allocated to (sham vs real treatment)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Experiment 1: Response to real intervention compared between fibromyalgia and healthy control group Experiment 2: Fibromyalgia participants allocated to real or sham intervention

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 23, 2023
• Study Start: November 1, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)