Effects of taVNS on Fibromyalgia Pain

Part of paid clinical trials in Cambridge, Massachusetts.

Sponsor
Spaulding Rehabilitation Hospital
Study ID
NCT06193317
Status
Not Yet Recruiting

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Conditions

  • Fibromyalgia, Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transauricular vagus nerve stimulation (taVNS) — DEVICE
    Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN).

Study Details

Transauricular vagus nerve stimulation (taVNS) is a newer delivery system, using a non-invasive stimulation device placed at the ear's concha. TaVNS is a portable, safe, and low-cost intervention, and according to some studies, taVNS may influence nociception and pain perception, which can lead to potential applications for various painful illnesses, including fibromyalgia (FM). This trial aims to investigate the clinical effects of taVNS on pain control in FM subjects.

Key Dates

Start date
Jun 1, 2026
Status verified
Sep 2025
Primary completion
May 1, 2028
Completion
May 1, 2029

Study Design

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

Arms

  • Experimental: Active taVNS
    TaVNS will be administered by an earset, with conductive eartips placed on the auricular concha of the ears, connected to a stimulator, and during active stimulation, we stimulate both the cymba conchae and external auditory canal of both left and right ears with the following parameters: 30Hertz (Hz), 200-250 us, and with adjustable intensity for 60 min for 16 sessions.
  • Sham Comparator: Sham taVNS
    Sham condition will have the same device, with an earset, and conductive eartips placed in the same location of the active stimulation; however during 60 min for 16 sessions there will be no current and the device will be turned off.

Primary Outcome Measure

pain severity using the Brief Pain Inventory (BPI pain) [ Time Frame: From Baseline to Visit 19 (at 4 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Spaulding Hospital CambridgeCambridgeMassachusetts02138-

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Spaulding Hospital Cambridge· Cambridge, MA