taVNS for Fibromyalgia
ME
Overseen ByMaya Eshel, BA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
What You Need to Know Before You Apply
What is the purpose of this trial?
In this research study we want to learn more about if transcutaneous electrical nerve stimulation (TENS), a safe electrical stimulation tool, can relieve Fibromyalgia pain. A total of 60 subjects with Fibromyalgia will be enrolled in this study at Massachusetts General Hospital, Charlestown Navy Yard campus.
Who Is on the Research Team?
JK
Jian Kong
Principal Investigator
MGH
Are You a Good Fit for This Trial?
This trial is for individuals who meet the American College of Rheumatology's criteria for Fibromyalgia, are willing to undergo a 4-week treatment twice daily, and have at least a 10th grade English-reading level. It's not specified who can't join.Inclusion Criteria
Meet the American College of Rheumatology (ACR) 1990 classification criteria and the ACR 2010 diagnostic criteria for fibromyalgia as determined by clinicians.
At least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures.
I am willing to undergo a 4-week treatment twice a day.
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive transcutaneous auricular vagus nerve stimulation (taVNS) for 4 weeks
4 weeks
Baseline, week 2, and week 4 visits
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Auricular transcutaneous electrical nerve stimulation device
Trial Overview The study is testing if taVNS (auricular transcutaneous electrical nerve stimulation), which is a safe electrical stimulation device, can help relieve pain in people with Fibromyalgia. The trial will enroll 60 subjects at Massachusetts General Hospital.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: taVNS Group1Experimental Treatment1 Intervention
This group will receive taVNS for 4 weeks.
Group II: taVNS Group 2Experimental Treatment1 Intervention
This group will receive taVNS for 4 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Trials
3,066
Recruited
13,430,000+
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