Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02969642
Recruitment Status : Unknown
Verified December 2016 by The San Francisco Clinical Research Center.
Recruitment status was:  Recruiting
First Posted : November 21, 2016
Last Update Posted : December 2, 2016
Sponsor:
Information provided by (Responsible Party):
The San Francisco Clinical Research Center

Tracking Information
First Submitted Date  ICMJE October 20, 2016
First Posted Date  ICMJE November 21, 2016
Last Update Posted Date December 2, 2016
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2016)
Differences between treatment groups in pain free rates at 2 hours post treatment. [ Time Frame: 2 hours post treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Low-level Laser Therapy in the Acute Treatment of Migraine
Official Title  ICMJE A Single-center, Sham-controlled, Single Attack Study of Laser Therapy to the Sphenopalatine Ganglion (SPG) in the Acute Treatment of Migraine
Brief Summary This study evaluates the treatment of migraine pain using low energy laser light to quench migraine signals issuing from the sphenopalatine ganglion (SPG).
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine Headache
Intervention  ICMJE Device: Argus Migraine Treatment device
treatment of Migraines targeting Sphenopalatine ganglion
Other Name: low energy laser therapy
Study Arms  ICMJE
  • Sham Comparator: Sham
    Sham low energy laser using approximately 1/1000 th energy of treatment laser.
    Intervention: Device: Argus Migraine Treatment device
  • Active Comparator: Treatment
    Treatment laser.
    Intervention: Device: Argus Migraine Treatment device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 18, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2017
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02969642
Other Study ID Numbers  ICMJE AP 1001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The San Francisco Clinical Research Center
Study Sponsor  ICMJE The San Francisco Clinical Research Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The San Francisco Clinical Research Center
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP