A Study of Remote Electrical Neuromodulation for Acute Procedural Pain

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT05730556
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Nerivio ® — DEVICE
    Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.
  • Sham — DEVICE
    Electrical stimulation to mimic study treatment intervention

Study Details

The purpose of this study is to assess the effectiveness of using remote electrical neuromodulation, using the Nerivio ® device, to relieve pain associated with receiving onabotulinumtoxinA (Botox) injections for chronic migraine prevention.

Key Dates

Start date
Feb 13, 2023
Status verified
Sep 2025
Primary completion
Sep 9, 2024
Completion
Sep 9, 2024

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Electrical Neuromodulation, Then Sham
    Subjects will first have the Nerivio ® applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continue to wear the device for a total of 40 to 45 minutes at week 12. Subjects will then have the sham device applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continue to wear the device for a total of 40 to 45 minutes at week 24.
  • Experimental: Sham, Then Electrical Neuromodulation
    Subjects will first have the sham device applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continue to wear the device for a total of 40 to 45 minutes at week 12. Subjects will then have the Nerivio ® applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continue to wear the device for a total of 40 to 45 minutes at week 24.

Primary Outcome Measure

Change in Pain Intensity Measured by Visual Analog Scale (VAS) [ Time Frame: Baseline, Week 12, Week 24 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-

Find similar trials in Scottsdale, AZ

By condition
Migraine
By specialty
Neurology
By research site
Mayo Clinic in Arizona· Scottsdale, AZ

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