Pathway M-1: Sphenopalatine Ganglion Stimulation for the AcuteTreatment of High Disability Migraine Headache

NCT01540799 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-06-26

No results posted yet for this study

Summary

The purpose of the clinical study is to evaluate the use of an implanted sphenopalatine ganglion (SPG) neurostimulator for the treatment of migraine headache pain, migraine headache symptoms and migraine frequency in high disability migraineurs.

Conditions

  • High Frequency, High Disability Migraine

Interventions

DEVICE

ATI Neurostimulation System

ATI Neurostimulator (NS-100) and Remote Controller (RC-200)

Sponsors & Collaborators

  • Autonomic Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Rigmor Jensen, MD, PhD · Danish Headache Center, Glostrup Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • Belgium
  • Denmark
  • Spain

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 NCT01540799 on ClinicalTrials.gov