A Feasibility Clinical Trial to Evaluate High Frequency Spinal Cord Stimulation for the Treatment of Patients With Chronic Migraine

NCT01653340 | Completed

• 2 other identifiers: CE1001122012-002005-22
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Refractory Chronic Migraine

Keywords

Refractory Chronic Migraine; Medically Intractable Chronic Migraine; High Frequency Spinal Cord Stimulator

Outcome Measures

Primary Outcomes (3)

• Frequency in headache days

  Change of frequency in headache days from baseline

  three and six months

• Frequency in migraine days

  Change of frequency in migraine days from baseline

  three and six months

• Frequency of moderate/severe headache days

  Change in frequency of moderate/severe headache days from baseline

  three and six months

Secondary Outcomes (8)

• headache pain Visual Analog Scale (VAS)

  three and six months

• HIT-6

  three and six months

• Migraine Disability Assessment (MIDAS)

  three and six months

• Frequency of triptans intake

  three and six months

• Patient Global Impression of Change (PGIC)

  three and six months

Study Arms (1)

High Frequency Spinal Cord Stimulation through Senza™

EXPERIMENTAL

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

Interventions

Senza™, High Frequency Spinal Cord Stimulator for Refractory Chronic Migraine DEVICE

http://nevro.com/corporate/system-us

High Frequency Spinal Cord Stimulation through Senza™

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• King's College Hospital NHS Trust: collaborator

Study Sites (1)

Sant'Andrea Hospital

Roma, RM, 00189, Italy

Location

Study Officials

• Paolo Martelletti, MD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Internal Medicine

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: July 31, 2012
• Study Start: May 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 19, 2014

Record last verified: 2014-02

Locations

IT (1)