taVNS Treatment for Fibromyalgia

Part of paid clinical trials in Charlestown, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04777500
Status
Not Yet Recruiting

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Conditions

  • Fibromyalgia

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Auricular transcutaneous electrical nerve stimulation device — DEVICE
    We are investigating whether taVNS can relieve chronic pain symptoms associated with Fibromyalgia.

Study Details

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.

Key Dates

Start date
Oct 3, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: taVNS Group1
    This group will receive taVNS for 4 weeks.
  • Experimental: taVNS Group 2
    This group will receive taVNS for 4 weeks.

Primary Outcome Measure

Revised Fibromyalgia Impact Questionnaire (FIQR) [ Time Frame: Baseline, week 2 and week 4. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalCharlestownMassachusetts02129-2020

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