Study of Low-level Laser Therapy in the Acute Treatment of Migraine

December 1, 2016 updated by: The San Francisco Clinical Research Center

A Single-center, Sham-controlled, Single Attack Study of Laser Therapy to the Sphenopalatine Ganglion (SPG) in the Acute Treatment of Migraine

This study evaluates the treatment of migraine pain using low energy laser light to quench migraine signals issuing from the sphenopalatine ganglion (SPG).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a double blinded, two arm study, comprising a sham laser and a treatment laser. The sham laser emits approximately 1/1000 the energy of the treatment laser.

It is presumed that pain relief from the treatment laser is achieved by exhausting the release of neurotransmitters from the SPG following laser stimulation. Subjects will be treated and subsequently queried at time intervals for their self-assessment of pain score (VAS). The time intervals include queries at 5 minutes through 2 hours post treatment. Subjects will be further contacted 24 hours and one month post treatment. Adverse events will be monitored and recorded.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94109
        • Recruiting
        • San Francisco Clinical Research Center
        • Contact:
        • Principal Investigator:
          • Jerome Goldstein, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • male or female
  • aged 18 or older;
  • subject diagnosed with migraine according to The International Classification of Headache Disorders- Version 3;
  • 1-20 headache days per month;
  • history of at least moderate pain if migraine left untreated.

Exclusion Criteria:

  • headache on greater than 25 days/month on average for preceding 3 months;
  • headache on greater than 25 days in present month;
  • headache attributed to: head or neck trauma, cluster headache, specific migraine variants such as basilar artery, ophthalmoplegic, hemiplegic, etc;
  • women of child bearing age not using acceptable method of contraception;
  • pregnant or nursing women;
  • history of malignancy of any organ
  • uncontrolled: hypertension, severe psychiatric disorders, or known use of narcotics, analgesic or alcohol abuse;
  • light sensitivity;
  • retinal disease;
  • intranasal pathology.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Sham
Sham low energy laser using approximately 1/1000 th energy of treatment laser.
Device: Argus Migraine Treatment device
treatment of Migraines targeting Sphenopalatine ganglion
Other Names:
  • low energy laser therapy
ACTIVE_COMPARATOR: Treatment
Treatment laser.
Device: Argus Migraine Treatment device
treatment of Migraines targeting Sphenopalatine ganglion
Other Names:
  • low energy laser therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences between treatment groups in pain free rates at 2 hours post treatment.
Time Frame: 2 hours post treatment
2 hours post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The San Francisco Clinical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2017

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

October 20, 2016

First Submitted That Met QC Criteria

November 18, 2016

First Posted (ESTIMATE)

November 21, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 2, 2016

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP 1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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