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Prospective, Multi-Center Evaluation of the Efficacy of Peripheral Trigger Decompression Surgery for Migraine Headaches

This study is currently recruiting participants.
Verified January 2017 by Janis, Jeffrey E, MD, Ohio State University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02351544
First Posted: January 30, 2015
Last Update Posted: January 18, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Wisconsin, Madison
Massachusetts General Hospital
University Hospitals Cleveland Medical Center
Information provided by (Responsible Party):
Janis, Jeffrey E, MD, Ohio State University
  Purpose

According to the peripheral trigger theory of migraine headaches, nociceptive inputs from irritated or compressed cranial nerve branches can lead to neurovascular changes in the brain that cause migraine headaches. Advanced treatments aimed at deactivating the peripheral trigger points can be administered to patients who have failed medical management of migraines. Those accepted advanced treatments include botulinum toxin A injection in order to temporarily paralyze muscles causing nerve compression, and surgery to release those compression points permanently. An advantage of surgery is the ability to release non-muscular causes of nerve compression, such as fascial bands or intersecting arteries.

Botulinum toxin A injection into trigger sites has been shown in multiple studies to be effective at reducing the frequency and severity of migraine headaches, and is a very commonly administered treatment for refractory migraines. It is approved by the FDA for the treatment of chronic migraines.

Similarly, surgical decompression of trigger sites has previously been shown to have superior clinical outcomes to medical management, through a randomized, blinded controlled-trial performed at Case Western Reserve in 2009. Patients either received actual decompression of the trigger sites, or sham surgery (exposure and visualization of the trigger sites, without decompression). At one-year follow-up, the group who underwent actual surgery demonstrated a statistically higher proportion with significant improvement in their migraines (83.7% vs. 57.7%, p=0.014), and with complete elimination of their migraines (57.1% vs. 3.8%, p<0.001). Several other reports have confirmed the good clinical outcomes of surgery demonstrated in this trial, and surgical decompression is now commonly performed by several surgeons around the United States.

Prognostic factors predicting the success of surgical decompression in migraine headache treatment include older age of migraine onset, visual symptoms/aura, and 4-site decompression. Factors predicting failure of surgery include excessive operative blood loss, and surgery on only one or two trigger sites.

One criticism of the studies on peripheral trigger decompression surgery for migraines has been that most of the results have originated from the same institution (Case Western Reserve), and from the same author (Guyuron). While several studies at other institutions have demonstrated positive outcomes of peripheral trigger decompression, these have only included a small number of patients.

In addition, the sham surgery randomized-controlled trial has been criticized for not clarifying any prior treatments that patients had undergone before peripheral trigger deactivation, and for not showing how medication use patterns changed after surgery. Another criticism of that study was the fact that patients were examined by neurologists before the study but not after the study, and that surgery was performed on some patients with episodic migraines, who are known to not benefit from botulinum toxin. It is unclear what migraine types are most likely to benefit from surgical decompression.

The investigators' goal is to perform a multi-center, prospective trial to demonstrate the effectiveness of peripheral trigger decompression in the treatment of migraine headaches, which would address the criticisms mentioned above. The main aim is to demonstrate that the positive results demonstrated by Guyuron et al are reproducible at other institutions and by other surgeons using similar techniques on different patient populations.


Condition Intervention
Migraine Headaches Drug: Botulinum Toxin Type A Procedure: Surgery Other: Daily headache diary Other: Migraine Disability Assessment Test (MIDAS) Other: Migraine Work and Productivity Loss Questionnaire (MWPLQ) Other: Migraine-Specific Quality of Life Questionnaire (MSQ)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Janis, Jeffrey E, MD, Ohio State University:

Primary Outcome Measures:
  • Migraine Headache Index (MHI) at 3 months [ Time Frame: 3 months postoperatively ]
  • Migraine Headache Index (MHI) at 6 months [ Time Frame: 6 months postoperatively ]
  • Migraine Headache Index (MHI) at 1 year [ Time Frame: 1 year postoperatively ]
  • Migraine Headache Index (MHI) at 2 years [ Time Frame: 2 years postoperatively ]
  • Migraine Headache Index (MHI) at 2.5 years [ Time Frame: 2.5 years postoperatively ]

Secondary Outcome Measures:
  • Migraine Disability Assessment Test (MIDAS) score at 1 year [ Time Frame: 1 year postoperatively ]
  • Migraine Disability Assessment Test (MIDAS) score at 2 years [ Time Frame: 2 years postoperatively ]
  • Migraine Disability Assessment Test (MIDAS) score at 2.5 years [ Time Frame: 2.5 years postoperatively ]
  • Migraine Work and Productivity Loss Questionnaire (MMWPLQ) score at 1 year [ Time Frame: 1 year postoperatively ]
  • Migraine Work and Productivity Loss Questionnaire (MMWPLQ) score at 2 years [ Time Frame: 2 years postoperatively ]
  • Migraine Work and Productivity Loss Questionnaire (MMWPLQ) score at 2.5 years [ Time Frame: 2.5 years postoperatively ]
  • Migraine-Specific Quality of Life Questionnaire (MSQ) score at 1 year [ Time Frame: 1 year postoperatively ]
  • Migraine-Specific Quality of Life Questionnaire (MSQ) score at 2 years [ Time Frame: 2 years postoperatively ]
  • Migraine-Specific Quality of Life Questionnaire (MSQ) score at 2.5 years [ Time Frame: 2.5 years postoperatively ]
  • Migraine treatment cost for 2 months [ Time Frame: For 2 months postoperatively ]

Estimated Enrollment: 100
Study Start Date: September 2015
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botulinum toxin
Patients in this arm will receive botulinum toxin for migraine headaches
Drug: Botulinum Toxin Type A Other: Daily headache diary Other: Migraine Disability Assessment Test (MIDAS) Other: Migraine Work and Productivity Loss Questionnaire (MWPLQ) Other: Migraine-Specific Quality of Life Questionnaire (MSQ)
Experimental: Surgery
Patients in this arm will receive surgery for migraine headaches
Procedure: Surgery Other: Daily headache diary Other: Migraine Disability Assessment Test (MIDAS) Other: Migraine Work and Productivity Loss Questionnaire (MWPLQ) Other: Migraine-Specific Quality of Life Questionnaire (MSQ)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with migraines related to a trigger site at the location of a branch of a cranial nerve (frontal, temporal, occipital)
  • Patients with chronic migraine (≥15 days per month) as dictated by the FDA indication for botulinum, and as diagnosed by a board-certified neurologist
  • Patients with episodic migraines

    • Those patients are included because there is no consensus whether surgical decompression is effective for chronic migraines only, or for chronic and episodic migraines. One of the goals of this trial is to determine this.
  • Patients who respond to diagnostic botulinum toxin injection or to a diagnostic anesthetic block
  • Patients who have failed 2 of 3 classes of preventative migraine medications

Exclusion Criteria:

  • Patients deemed by the authors or the neurologist to not have migraine headaches, but an alternative diagnosis
  • Patients with systemic conditions that make them poor candidates for surgery (coronary artery disease, uncontrolled diabetes mellitus, etc…)
  • Patients with migraines related to inferior turbinate hypertrophy or septal deviation
  • Patients with a frontal, temporal or occipital trigger point who do not respond to a diagnostic botulinum toxin injection or to a diagnostic anesthetic block
  • Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation
  • Infection at the proposed injection site for botulinum
  • Patients with trigger points at minor trigger sites (lesser occipital nerve, third occipital nerve)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02351544


Contacts
Contact: Jeffrey E Janis, MD FACS 614-366-1704 Jeffrey.Janis@osumc.edu

Locations
United States, California
Peled Plastic Surgery Recruiting
San Francisco, California, United States, 94118
Contact: Ziv Peled, MD    415-751-0583      
Principal Investigator: Ziv Peled, MD         
United States, Kansas
Premier Plastic Surgery of Kansas City Recruiting
Olathe, Kansas, United States, 66061
Contact: John B Moore, MD    913-782-0707      
Principal Investigator: John B Moore, MD         
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: William G Austen, MD    617-724-9922      
Principal Investigator: William G Austen, MD         
United States, Missouri
Neuropax Clinic Recruiting
St Louis, Missouri, United States, 63161
Contact: Robert Hagan, MD    314-434-7784      
Principal Investigator: RObert Hagan, MD         
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Jeffrey E Janis, MD         
Sub-Investigator: Ibrahim Z Khansa, MD         
United States, Wisconsin
The University of Wisconsin-Madison Not yet recruiting
Madison, Wisconsin, United States, 53792
Contact: Ahmed Afifi, MD    608-263-1400      
Principal Investigator: Ahmed Afifi, MD         
Sponsors and Collaborators
Ohio State University
University of Wisconsin, Madison
Massachusetts General Hospital
University Hospitals Cleveland Medical Center
  More Information

Responsible Party: Janis, Jeffrey E, MD, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02351544     History of Changes
Other Study ID Numbers: 2015H0024
First Submitted: January 21, 2015
First Posted: January 30, 2015
Last Update Posted: January 18, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents