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| Name | Class |
|---|---|
| Department of Anesthesiology & Perioperative Medicine, University of Pittsburgh | UNKNOWN |
| University of Pittsburgh Clinical and Translational Science Institute (CTSI) | UNKNOWN |
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The goal of this interventional study is to learn whether noninvasive brain stimulation (NIBS) will have an effect on pain perception in people with fibromyalgia. The main questions it aims to answer are:
Do repeated sessions of NIBS lead to a reduction in perceived pain? Do repeated sessions of NIBS lead to an improvement in quality of life?
Researchers will compare different brain targets to see if effects are different between them.
Participants will receive repeated daily sessions of NIBS over 4 weeks with application of pressure pain algometry, and complete various questionnaires.
Participants will randomly receive primary motor cortex (M1) or occipital lobe NIBS over 2 weeks, and after a wash-out period will receive NIBS of the other target over 2 weeks. Each session will also evaluate pressure pain algometry, various questionnaires to assess changes in fibromyalgia symptoms and quality of life (up to 5 hours per session)
NIBS administration will consist of 1000 electrical pulses of <1 ms duration each.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Motor Cortex Stimulation, then Occipital Lobe Stimulation | Experimental | The primary motor cortex will be targeted first, then the occipital lobe. |
|
| Occipital Lobe Stimulation, then Primary Motor Cortex Stimulation | Experimental | The occipital lobe will be targeted first, then the primary motor cortex. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary Motor Cortex Stimulation | Device | Short (<1 ms), high amplitude (>10 mA) noninvasive electrical pulses delivered at 1 Hz on the scalp surface. This intervention will target the primary motor cortex (M1). |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the transcranial electrical stimulation protocol | Feasibility of the protocol will be measured quantitatively using the Feasibility of Intervention Measure (FIM) score. Score ranges from 4 to 20, with higher scores indicating higher level of feasibility. It will also be assessed qualitatively via participant interviews. | From end of the last study session until up to 6 months after. |
| Tolerability of transcranial electrical stimulation protocol | Determined qualitatively from study-related participant attrition rate (%) and adherence to protocol (%). | Every day from enrollment until up to 6 months after the last study session. |
| Acceptability of transcranial electrical stimulation protocol | Acceptability of the protocol will be measured quantitatively using the Acceptability of Intervention Measure (AIM) score. Score ranges from 4 to 20, with higher scores indicating higher level of acceptability. It will also be assessed qualitatively via participant interviews. | From end of the last study session until up to 6 months after. |
| Pressure pain threshold (PPT) | PPT (in lbf) will be measured using a digital algometer, which will be used to press down on the participants' thumb nails and legs to assess pain sensitization throughout the study. | At every study session from Session 1 until the last study session. |
| Measure | Description | Time Frame |
|---|---|---|
| Revised Fibromyalgia Impact Questionnaire (FIQR) | FIQR will be used to assess the participant's experience with fibromyalgia (symptoms and impact on daily life). Score ranges from 0 to 100, with higher scores indicating greater severity of fibromyalgia symptoms and functional impairment. | Weekly from enrollment until up to 6 months after the last study session. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of steps | Assess change in number of steps taken daily using a wearable device. | Every day from enrollment until up to 4 weeks after the last study session. |
| Active zone minutes | Assess change in number of minutes spent in active heart rate zone using a wearable device. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pulkit Grover, PhD | Contact | 412-268-3644 | pgrover@andrew.cmu.edu | |
| Benedict J Alter, PhD | Contact | 412-677-0575 | alterbj@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pulkit Grover, PhD | Carnegie Mellon University | Principal Investigator |
| Benedict J Alter, MD, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Pain Management | Pittsburgh | Pennsylvania | 15206 | United States |
IPD may be shared upon reasonable request to the study contacts.
Data will become available after publication per journal and funding entity protocols.
Data will be made available by reasonable request and/or per journal and funding entity protocols.
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| Occipital Lobe Stimulation | Device | Short (<1 ms), high amplitude (>10 mA) noninvasive electrical pulses delivered at 1 Hz on the scalp surface. This intervention will target the occipital lobe. |
|
|
| Brief Pain Inventory (BPI) | BPI will be used to assess the participant's pain severity and interference. Score ranges from 0 to 10, with higher scores indicating worse (more severe) pain or interference. | Daily, from enrollment until up to 6 months after the last study session. |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) | We will use the standardized survey score PROMIS-29 to assess physical and mental health in seven domains (e.g., physical function, anxiety, sleep disturbance etc.). Each question score ranges from one to five, corresponding to the intensity within the question's domain. Survey scores will be converted to a t-score metric and assessed. | Weekly, from enrollment until up to 6 months after the last study session. |
| Every day from enrollment until up to 4 weeks after the last study session. |
| Sleep score | Assess change in sleep quality using a wearable device. | Every day from enrollment until up to 4 weeks after the last study session. |
| Carnegie Mellon University | Pittsburgh | Pennsylvania | 15213 | United States |
|
| D009422 |
| Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |