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A PIVOTAL STUDY EVALUATING SAFETY AND EFFICACY OF THE SHIRATRONICS MIGRAINE THERAPY SYSTEM

NCT06167655 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-04-14

No results posted yet for this study

Summary

Prospective, multi-center, double blind, randomized, sham-controlled study to evaluate neuromodulation in patient with chronic migraine. The study hypothesis to be tested is the mean reduction in mean monthly headache days between patients in treatment versus sham.

Conditions

  • Headache Migraine Chronic

Interventions

DEVICE

Neurostimulator

Neurostimulation system that applies stimulation to nerve pathways in the head associated with migraine symptoms.

Sponsors & Collaborators

  • ShiraTronics

    lead INDUSTRY

Principal Investigators

  • Brian Grosberg, MD · Hartford Headache Center

  • Samer Narouze, MD · University Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-29
Primary Completion
2027-03-31
Completion
2031-05-31
FDA Device
Yes

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06167655 on ClinicalTrials.gov