A Feasibility Clinical Trial to Evaluate High Frequency Spinal Cord Stimulation for the Treatment of Patients With Chronic Migraine (rCM HF-SCS)

This study has been completed.
Sponsor:
Collaborators:
Guy's and St Thomas' NHS Foundation Trust
King's College Hospital NHS Trust
Information provided by (Responsible Party):
Paolo Martelletti, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01653340
First received: July 24, 2012
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to assess short- and long-term safety, tolerability and efficacy of cervical High Frequency Spinal Cord Stimulation (HF-SCS) in patients suffering from chronic migraine refractory to conventional medical therapy.


Condition Intervention
Refractory Chronic Migraine
Device: Senza™, High Frequency Spinal Cord Stimulator for Refractory Chronic Migraine

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Clinical Trial to Evaluate High Frequency Spinal Cord Stimulation for the Treatment of Patients With Chronic Migraine

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Frequency in headache days [ Time Frame: three and six months ] [ Designated as safety issue: Yes ]
    Change of frequency in headache days from baseline

  • Frequency in migraine days [ Time Frame: three and six months ] [ Designated as safety issue: Yes ]
    Change of frequency in migraine days from baseline

  • Frequency of moderate/severe headache days [ Time Frame: three and six months ] [ Designated as safety issue: Yes ]
    Change in frequency of moderate/severe headache days from baseline


Secondary Outcome Measures:
  • headache pain Visual Analog Scale (VAS) [ Time Frame: three and six months ] [ Designated as safety issue: Yes ]
    Change in headache pain Visual Analog Scale (VAS) score from baseline

  • HIT-6 [ Time Frame: three and six months ] [ Designated as safety issue: Yes ]
    Change in HIT-6 score from baseline

  • Migraine Disability Assessment (MIDAS) [ Time Frame: three and six months ] [ Designated as safety issue: Yes ]
    Change in Migraine Disability Assessment (MIDAS) Score from baseline

  • Frequency of triptans intake [ Time Frame: three and six months ] [ Designated as safety issue: Yes ]
    Change in frequency of triptans intake from baseline

  • Patient Global Impression of Change (PGIC) [ Time Frame: three and six months ] [ Designated as safety issue: Yes ]
    Patient Global Impression of Change (PGIC)

  • Quality of Life [ Time Frame: three and six months ] [ Designated as safety issue: Yes ]
    Change in Quality of Life from baseline

  • sleep disturbances [ Time Frame: three and six months ] [ Designated as safety issue: Yes ]
    Change in the number of sleep disturbances per night from baseline

  • Device-related adverse events [ Time Frame: Three and six months ] [ Designated as safety issue: Yes ]
    Incidence of device-related adverse events


Enrollment: 18
Study Start Date: May 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Frequency Spinal Cord Stimulation through Senza™

During the trial implant of Senza™, High Frequency Spinal Cord Stimulator for Refractory Chronic Migraine, the 2 leads will be positioned to cover the C2-C3 cervical levels.

Over the following 2 weeks, the investigator will optimize therapy delivery by identifying the stimulation settings providing maximal headache pain relief.

The subject will be asked to attend the clinic at the end of the trial period. Together with his/her physician, the subject will discuss his/her experience over the past 2 weeks (satisfaction with the therapy), and decide whether or not move forward with a Nevro Senza IPG.

The Nevro Senza IPG will be implanted in the buttock or abdomen area as outlined in the Physician's Manual. Fluoroscopy and impedance measurements may be used during the procedure to confirm lead placement and location.

Before hospital discharge, the IPG will be programmed with the optimal settings identified during the trial phase.

Device: Senza™, High Frequency Spinal Cord Stimulator for Refractory Chronic Migraine
http://nevro.com/corporate/system-us

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  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • An adult between the age of 18 and 65

    • Capable of providing informed consent
    • A diagnosis of chronic (>15 or more headache-days per 4 week period for more than 3 months, with an headache-day being defined as a day with an attack lasting a minimum of 4 hours) migraine refractory to conventional medical treatment (has failed at least 2 preventive and 2 abortive drugs) as per the ICHD-II guidelines.
    • On optimal and stable preventive headache pharmacological migraine therapy for at least 2 months
    • Failed treatment with Onabotulinumtoxin A for 12 months
    • Able to comply with the requirements of the study visits and self-assessment questionnaires Able to provide informed consent and willing to comply with study procedures

Exclusion Criteria:

  • • medication-overuse headache

    • Had treatment with Onabotulinumtoxin A in the last 3 months
    • An already implanted active medical device
    • A contraindication to the cervical placement of SCS lead
    • A life expectancy of less than 1 year
    • A female of child bearing potential who is pregnant/lactating or not using adequate birth control
    • Beck Depression Inventory score of >24
    • Evidence of an active disruptive psychological/psychiatric disorder or other known condition significant enough to impact perception of pain (e.g. fibromyalgia), compliance of intervention and/or ability to evaluate treatment outcome as determined by the Investigator
    • Addiction to any of the following: illicit drugs, alcohol (5 or more drinks/day), and/or medication
    • Bleeding diathesis such as coagulopathy or thrombocytopenia
    • Immuno-compromised and at risk for infection
    • Diabetic which is not under control as determined by the Investigator
    • Unresolved issue of secondary gain
    • Inability to manage the technical demands of the SCS equipment
    • Currently participating in a randomized clinical trial with an active treatment arm or planned to be enrolled in another clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653340

Locations
Italy
Sant'Andrea Hospital
Roma, RM, Italy, 00189
Sponsors and Collaborators
University of Roma La Sapienza
Guy's and St Thomas' NHS Foundation Trust
King's College Hospital NHS Trust
Investigators
Principal Investigator: Paolo Martelletti, MD University of Roma La Sapienza
  More Information

No publications provided

Responsible Party: Paolo Martelletti, Professor, Internal Medicine, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01653340     History of Changes
Other Study ID Numbers: CE100112, 2012-002005-22
Study First Received: July 24, 2012
Last Updated: February 17, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by University of Roma La Sapienza:
Refractory Chronic Migraine
Medically Intractable Chronic Migraine
High Frequency Spinal Cord Stimulator

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 16, 2014