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

This study is currently recruiting participants.

Verified September 2012 by University of Roma La Sapienza

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: September 4, 2012

Last verified: September 2012

History of Changes

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:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

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

Estimated Enrollment:	10
Study Start Date:	May 2012
Estimated Primary Completion Date:	March 2013 (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

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

Show Detailed Description

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

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

Contacts

Contact: Paolo Martelletti, MD	+390633776778	paolo.martelletti@uniroma1.it
Contact: Valerio De Angelis, PhD	+390633264731	valerio.deangelis@uniroma1.it

Locations

Italy
Sant'Andrea Hospital	Recruiting
Roma, RM, Italy, 00189
Contact: Paolo Martelletti, MD +390633776778 paolo.martelletti@uniroma1.it
Contact: Valerio De Angelis, PhD +390633274631 valerio.deangelis@uniroma1.it

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:	September 4, 2012
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 May 16, 2013

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