FibromyalgiaNCT06006130
Neurophysiology of Fibromyalgia
A study of Fibromyalgia, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years old
Who cannot join
- contraindications to TMS
- chronic pain associated with diagnoses other than fibromyalgia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Neurobiological Contributions to Pain in Patients With Fibromyalgia
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:
- Compare the neurophysiological responses in fibromyalgia compared to healthy controls.
- Determine whether a two-week cTMS protocol will alter pain in individuals with fibromyalgia.
Read the detailed description
Fibromyalgia is a syndrome associated with fatigue and chronic pain, leading to significant physical limitations and impaired quality of life. Fibromyalgia affects 1.7% of Canadians, with a higher prevalence in females compared to males at 9:1 [1]. 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. Chronic pain in fibromyalgia arises in the absence of tissue pathology, and consequently a lack of consensus on reliable diagnostic criteria. Understanding the pathophysiology of fibromyalgia would aid in the identification of objective biomarkers that could be used for diagnosis.
Multiple theories have been posited to explain the genesis of chronic pain. The gate control theory describes the attenuation of pain signals in the spinal cord prior to cortical processing, and it has been hypothesized that loss of this gate control leads to the genesis of chronic pain [2]. Gate control can be observed by reduction of afferent signals during active muscle contraction. For example, the amplitude of the somatosensory-evoked potential (SEP) is attenuated during active contraction [3]. To our knowledge, it is unknown whether such gate control is observed in fibromyalgia. The lack of gate control may contribute to chronic pain in this population.
The sensorimotor theory suggests that incongruency between motor intention and sensory feedback underlies chronic pain where there is an absence of tissue pathology [4]. This may align with the genesis of fibromyalgia, given the findings that those with fibromyalgia have altered tactile and proprioceptive functioning [5]. Corticomuscular coherence (CMC) is a useful tool that uses electroencephalography (EEG) and electromyography (EMG) to probe the synchrony of neural firing between the brain and muscle [6]. To our knowledge, it is unknown how the magnitude of CMC varies in fibromyalgia compared to healthy controls.
Non-invasive brain stimulation in the form of Transcranial Magnetic Stimulation (TMS) has been used to probe the activity of corticospinal and cortical networks in fibromyalgia. When TMS pulses are delivered in a repetitive train, a protocol known as repetitive TMS (rTMS), short-term neuroplasticity can be induced (i.e., a change in the activity of neurons in the brain). In fibromyalgia, Mhalla et al. [7] found that 5 days of 10 Hz rTMS reduced pain intensity and improved quality of life metrics. Controlled pulse parameter transcranial magnetic stimulation (cTMS) is a novel technique that may produce stronger analgesic effects by delivering monophasic pulses that could enhance neuroplasticity compared with conventional rTMS. It is unknown whether a longer intervention period or the use of cTMS could lead to greater analgesic effects.
Finally, central sensitization may explain the widespread chronic pain experienced in fibromyalgia. There are several neuromodulators that contribute to the neurobiology of central sensitization and may be implicated in this condition including serotonin, dopamine, and brain-derived neurotrophic factor (BDNF). Serotonin is linked to pain modulation, such that increased levels of 5-HT are associated with hyperalgesia [8]. BDNF has been implicated in the genesis of neuropathic pain [9]. In fibromyalgia compared to healthy controls, serum BDNF levels have been reported to be higher [10]. Abnormal dopamine function may also be associated with fibromyalgia [11]. Positron-emission tomography (PET) studies show lower cortical dopamine D2/D3 binding availability in fibromyalgia compared to healthy controls [12].
Ultimately, a combination of events may lead to widespread chronic pain in fibromyalgia. Understanding the neurophysiology of fibromyalgia would aid in the discovery of objective biomarkers for diagnosis. Therefore, the goals of this study are to:
- Compare the neurophysiological responses in fibromyalgia compared to healthy controls.
- Determine whether a two-week cTMS protocol will alter pain in individuals with fibromyalgia.
- Conditions
- Fibromyalgia
- Being tested
- Active Controlled Pulse Parameter Transcranial Magnetic Stimulation (cTMS), Sham Controlled Pulse Parameter Transcranial Magnetic Stimulation (cTMS)
- Keywords
- fibromyalgia, transcranial magnetic stimulation, neuroplasticity, pain
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Controlled Pulse Parameter Transcranial Magnetic Stimulation (cTMS)Device
cTMS is a non-invasive, non-painful procedure used to relieve chronic pain and promote short-term changes. The first dorsal interosseous (FDI) muscle of the left motor cortex will be targeted using neuronavigation software. 2000 pulses will be delivered at 10 Hz stimulation. Stimulation will be delivered at 80% of the resting motor threshold obtained from the right FDI muscle. The delivery of cTMS requires 11 minutes in total.
Sham Controlled Pulse Parameter Transcranial Magnetic Stimulation (cTMS)Device
A sham coil will be utilized for the sham cTMS 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 cTMS will be identical to Active cTMS.
| Study group | Role | What they receive |
|---|---|---|
| Active cTMS | Active comparator | Controlled Pulse Parameter Transcranial Magnetic Stimulation (cTMS) will be delivered at 10 Hz, 2000 pulses targeting the hand representation of the left primary motor cortex. cTMS 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. Receives: Device: Active Controlled Pulse Parameter Transcranial Magnetic Stimulation (cTMS) |
| Sham cTMS | Sham comparator | Sham cTMS 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 cTMS. 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. Receives: Device: Sham Controlled Pulse Parameter Transcranial Magnetic Stimulation (cTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
Will be used to assess the patients feeling and emotion related to their pain experience
Measured: 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)
Will be used to assess for symptoms of for Major Depressive Disorder and Generalized Anxiety Disorder
Measured: 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)
Will be used to screen for symptoms of Posttraumatic Stress Disorder (PTSD)
Measured: Experiment 1: At baseline pre-intervention, Experiment 2: At baseline pre-intervention and 2 weeks post-intervention
Change in Motor-evoked potentials (MEPs)
This will include an assessments of MEPs obtained using Transcranial Magnetic Stimulation (TMS).
Measured: 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)
This will include an assessments of SICI obtained using Transcranial Magnetic Stimulation (TMS).
Measured: 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 performance on sensorimotor tasks
Tasks include tactile localization, temporal order judgement (TOJ), and sequential amplitude discrimination
Measured: Experiment 1: At baseline pre-intervention, Experiment 2: At baseline pre-intervention and 2 weeks post-intervention
EEG assessment of Somatosensory-evoked potentials (SEPs)
This will include an assessment of SEPs using EEG electrodes.
Measured: Experiment 1: At baseline pre-intervention only
EEG assessment of Pain-related evoked potentials (PREPs)
This will include an assessment of PREPs using EEG electrodes.
Measured: Experiment 1: At baseline pre-intervention only
EEG assessment of Corticomuscular coherence (CMC)
This will include an assessment of CMC using EEG electrodes.
Measured: Experiment 1: At baseline pre-intervention only
EEG assessment of Event-related desynchronization (ERD)
This will include an assessment of ERD using EEG electrodes.
Measured: Experiment 1: At baseline pre-intervention only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Feb 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experiment 1: Response to real intervention compared between fibromyalgia and healthy control group Experiment 2: Fibromyalgia participants allocated to real or sham intervention
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aimee Nelson, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006130
- Sponsor's protocol ID
- 16482
- Status last verified
- Dec 2025
- First submitted
- 28 Jul 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Obata K, Noguchi K. BDNF in sensory neurons and chronic pain. Neurosci Res. 2006 May;55(1):1-10. doi: 10.1016/j.neures.2006.01.005. Epub 2006 Mar 3.
PubMed 16516994Ovrom EA, Mostert KA, Khakhkhar S, McKee DP, Yang P, Her YF. A Comprehensive Review of the Genetic and Epigenetic Contributions to the Development of Fibromyalgia. Biomedicines. 2023 Apr 7;11(4):1119. doi: 10.3390/biomedicines11041119.
PubMed 37189737Mhalla A, Baudic S, de Andrade DC, Gautron M, Perrot S, Teixeira MJ, Attal N, Bouhassira D. Long-term maintenance of the analgesic effects of transcranial magnetic stimulation in fibromyalgia. Pain. 2011 Jul;152(7):1478-1485. doi: 10.1016/j.pain.2011.01.034. Epub 2011 Mar 11.
PubMed 21397400Chowdhury A, Raza H, Meena YK, Dutta A, Prasad G. An EEG-EMG correlation-based brain-computer interface for hand orthosis supported neuro-rehabilitation. J Neurosci Methods. 2019 Jan 15;312:1-11. doi: 10.1016/j.jneumeth.2018.11.010. Epub 2018 Nov 16.
PubMed 30452976Toprak Celenay S, Mete O, Coban O, Oskay D, Erten S. Trunk position sense, postural stability, and spine posture in fibromyalgia. Rheumatol Int. 2019 Dec;39(12):2087-2094. doi: 10.1007/s00296-019-04399-1. Epub 2019 Jul 31.
PubMed 31367796Vitterso AD, Halicka M, Buckingham G, Proulx MJ, Bultitude JH. The sensorimotor theory of pathological pain revisited. Neurosci Biobehav Rev. 2022 Aug;139:104735. doi: 10.1016/j.neubiorev.2022.104735. Epub 2022 Jun 12.
PubMed 35705110Nakata H, Inui K, Wasaka T, Nishihira Y, Kakigi R. Mechanisms of differences in gating effects on short-and long-latency somatosensory evoked potentials relating to movement. Brain Topogr. 2003 Summer;15(4):211-22. doi: 10.1023/a:1023908707851.
PubMed 12866825Melzack R. Evolution of the neuromatrix theory of pain. The Prithvi Raj Lecture: presented at the third World Congress of World Institute of Pain, Barcelona 2004. Pain Pract. 2005 Jun;5(2):85-94. doi: 10.1111/j.1533-2500.2005.05203.x.
PubMed 17177754Yunus MB. The role of gender in fibromyalgia syndrome. Curr Rheumatol Rep. 2001 Apr;3(2):128-34. doi: 10.1007/s11926-001-0008-3.
PubMed 11286669
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Neurobiological Contributions to Pain in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT06006130
- Acronym / sponsor ID
- 16482
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, transcranial magnetic stimulation, neuroplasticity, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Compare the neurophysiological responses in fibromyalgia compared to healthy controls.
- Determine whether a two-week cTMS protocol will alter pain in individuals with fibromyalgia.
Detailed description
Fibromyalgia is a syndrome associated with fatigue and chronic pain, leading to significant physical limitations and impaired quality of life. Fibromyalgia affects 1.7% of Canadians, with a higher prevalence in females compared to males at 9:1 [1]. 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. Chronic pain in fibromyalgia arises in the absence of tissue pathology, and consequently a lack of consensus on reliable diagnostic criteria. Understanding the pathophysiology of fibromyalgia would aid in the identification of objective biomarkers that could be used for diagnosis.
Multiple theories have been posited to explain the genesis of chronic pain. The gate control theory describes the attenuation of pain signals in the spinal cord prior to cortical processing, and it has been hypothesized that loss of this gate control leads to the genesis of chronic pain [2]. Gate control can be observed by reduction of afferent signals during active muscle contraction. For example, the amplitude of the somatosensory-evoked potential (SEP) is attenuated during active contraction [3]. To our knowledge, it is unknown whether such gate control is observed in fibromyalgia. The lack of gate control may contribute to chronic pain in this population.
The sensorimotor theory suggests that incongruency between motor intention and sensory feedback underlies chronic pain where there is an absence of tissue pathology [4]. This may align with the genesis of fibromyalgia, given the findings that those with fibromyalgia have altered tactile and proprioceptive functioning [5]. Corticomuscular coherence (CMC) is a useful tool that uses electroencephalography (EEG) and electromyography (EMG) to probe the synchrony of neural firing between the brain and muscle [6]. To our knowledge, it is unknown how the magnitude of CMC varies in fibromyalgia compared to healthy controls.
Non-invasive brain stimulation in the form of Transcranial Magnetic Stimulation (TMS) has been used to probe the activity of corticospinal and cortical networks in fibromyalgia. When TMS pulses are delivered in a repetitive train, a protocol known as repetitive TMS (rTMS), short-term neuroplasticity can be induced (i.e., a change in the activity of neurons in the brain). In fibromyalgia, Mhalla et al. [7] found that 5 days of 10 Hz rTMS reduced pain intensity and improved quality of life metrics. Controlled pulse parameter transcranial magnetic stimulation (cTMS) is a novel technique that may produce stronger analgesic effects by delivering monophasic pulses that could enhance neuroplasticity compared with conventional rTMS. It is unknown whether a longer intervention period or the use of cTMS could lead to greater analgesic effects.
Finally, central sensitization may explain the widespread chronic pain experienced in fibromyalgia. There are several neuromodulators that contribute to the neurobiology of central sensitization and may be implicated in this condition including serotonin, dopamine, and brain-derived neurotrophic factor (BDNF). Serotonin is linked to pain modulation, such that increased levels of 5-HT are associated with hyperalgesia [8]. BDNF has been implicated in the genesis of neuropathic pain [9]. In fibromyalgia compared to healthy controls, serum BDNF levels have been reported to be higher [10]. Abnormal dopamine function may also be associated with fibromyalgia [11]. Positron-emission tomography (PET) studies show lower cortical dopamine D2/D3 binding availability in fibromyalgia compared to healthy controls [12].
Ultimately, a combination of events may lead to widespread chronic pain in fibromyalgia. Understanding the neurophysiology of fibromyalgia would aid in the discovery of objective biomarkers for diagnosis. Therefore, the goals of this study are to:
- Compare the neurophysiological responses in fibromyalgia compared to healthy controls.
- Determine whether a two-week cTMS protocol will alter pain in individuals with fibromyalgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Experiment 1: Response to real intervention compared between fibromyalgia and healthy control group Experiment 2: Fibromyalgia participants allocated to real or sham intervention
| Arm | Type | Receives |
|---|---|---|
| Active cTMS | Active comparator | Device: Active Controlled Pulse Parameter Transcranial Magnetic Stimulation (cTMS)Controlled Pulse Parameter Transcranial Magnetic Stimulation (cTMS) will be delivered at 10 Hz, 2000 pulses targeting the hand representation of the left primary motor cortex. cTMS 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. |
| Sham cTMS | Sham comparator | Device: Sham Controlled Pulse Parameter Transcranial Magnetic Stimulation (cTMS)Sham cTMS 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 cTMS. 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-65 years old
Key exclusion criteria (2 listed)
- contraindications to TMS
- chronic pain associated with diagnoses other than fibromyalgia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Controlled Pulse Parameter Transcranial Magnetic Stimulation (cTMS)cTMS is a non-invasive, non-painful procedure used to relieve chronic pain and promote short-term changes. The first dorsal interosseous (FDI) muscle of the left motor cortex will be targeted using neuronavigation software. 2000 pulses will be delivered at 10 Hz stimulation. Stimulation will be delivered at 80% of the resting motor threshold obtained from the right FDI muscle. The delivery of cTMS requires 11 minutes in total. | Device | Active cTMS |
| Sham Controlled Pulse Parameter Transcranial Magnetic Stimulation (cTMS)A sham coil will be utilized for the sham cTMS 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 cTMS will be identical to Active cTMS. | Device | Sham cTMS |
Primary outcome
Change in PROMIS-29 v2.0 Profile
Time frame: Experiment 1: At baseline pre-intervention, Experiment 2: At baseline pre-intervention and 2 weeks post-intervention
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).
Change in Fibromyalgia impact questionnaire (FIQ)
Time frame: Experiment 1: At baseline pre-intervention, Experiment 2: At baseline pre-intervention and 2 weeks post-intervention
This instrument will be used to assess the patients feeling and emotion related to their pain experience.
10 secondary outcomes
Change in Pain catastrophizing scale-EN-SF
Time frame: 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)
Time frame: 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)
Time frame: Experiment 1: At baseline pre-intervention, Experiment 2: At baseline pre-intervention and 2 weeks post-intervention
Change in Motor-evoked potentials (MEPs)
Time frame: 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)
Time frame: 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 performance on sensorimotor tasks
Time frame: Experiment 1: At baseline pre-intervention, Experiment 2: At baseline pre-intervention and 2 weeks post-intervention
EEG assessment of Somatosensory-evoked potentials (SEPs)
Time frame: Experiment 1: At baseline pre-intervention only
EEG assessment of Pain-related evoked potentials (PREPs)
Time frame: Experiment 1: At baseline pre-intervention only
EEG assessment of Corticomuscular coherence (CMC)
Time frame: Experiment 1: At baseline pre-intervention only
EEG assessment of Event-related desynchronization (ERD)
Time frame: Experiment 1: At baseline pre-intervention only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 16516994Obata K, Noguchi K. BDNF in sensory neurons and chronic pain. Neurosci Res. 2006 May;55(1):1-10. doi: 10.1016/j.neures.2006.01.005. Epub 2006 Mar 3.
- Background: PubMed 37189737Ovrom EA, Mostert KA, Khakhkhar S, McKee DP, Yang P, Her YF. A Comprehensive Review of the Genetic and Epigenetic Contributions to the Development of Fibromyalgia. Biomedicines. 2023 Apr 7;11(4):1119. doi: 10.3390/biomedicines11041119.
- Background: PubMed 21397400Mhalla A, Baudic S, de Andrade DC, Gautron M, Perrot S, Teixeira MJ, Attal N, Bouhassira D. Long-term maintenance of the analgesic effects of transcranial magnetic stimulation in fibromyalgia. Pain. 2011 Jul;152(7):1478-1485. doi: 10.1016/j.pain.2011.01.034. Epub 2011 Mar 11.
- Background: PubMed 30452976Chowdhury A, Raza H, Meena YK, Dutta A, Prasad G. An EEG-EMG correlation-based brain-computer interface for hand orthosis supported neuro-rehabilitation. J Neurosci Methods. 2019 Jan 15;312:1-11. doi: 10.1016/j.jneumeth.2018.11.010. Epub 2018 Nov 16.
- Background: PubMed 31367796Toprak Celenay S, Mete O, Coban O, Oskay D, Erten S. Trunk position sense, postural stability, and spine posture in fibromyalgia. Rheumatol Int. 2019 Dec;39(12):2087-2094. doi: 10.1007/s00296-019-04399-1. Epub 2019 Jul 31.
- Background: PubMed 35705110Vitterso AD, Halicka M, Buckingham G, Proulx MJ, Bultitude JH. The sensorimotor theory of pathological pain revisited. Neurosci Biobehav Rev. 2022 Aug;139:104735. doi: 10.1016/j.neubiorev.2022.104735. Epub 2022 Jun 12.
- Background: PubMed 12866825Nakata H, Inui K, Wasaka T, Nishihira Y, Kakigi R. Mechanisms of differences in gating effects on short-and long-latency somatosensory evoked potentials relating to movement. Brain Topogr. 2003 Summer;15(4):211-22. doi: 10.1023/a:1023908707851.
- Background: PubMed 17177754Melzack R. Evolution of the neuromatrix theory of pain. The Prithvi Raj Lecture: presented at the third World Congress of World Institute of Pain, Barcelona 2004. Pain Pract. 2005 Jun;5(2):85-94. doi: 10.1111/j.1533-2500.2005.05203.x.
- Background: PubMed 11286669Yunus MB. The role of gender in fibromyalgia syndrome. Curr Rheumatol Rep. 2001 Apr;3(2):128-34. doi: 10.1007/s11926-001-0008-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Fibromyalgia, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PROMIS-29 v2.0 Profile (time frame: Experiment 1: At baseline pre-intervention, Experiment 2: At baseline pre-intervention and 2 weeks post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06006130, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.