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Study of MRgFUS Exablate Treatment Following the Neuropathic Pain

Primary Purpose

Neuropathic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Exablate treatment
Sponsored by
InSightec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Peripheral Neuropathic Pain, Trigeminal Pain, Central Neuropathic Pain, MRgFUS

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women age 30 years or older
  • Subject has diagnosis of "definite" neuropathic pain (grading system IASP-NeupSIG)
  • Patient has a score of 6 or higher on the Numeric Rating Scale (NRS)
  • Evidence that the subject has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different medication classes
  • Evidence that the subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation

Exclusion Criteria:

  • Subject diagnosed with a nociceptive chronic pain syndrome
  • Subject does not agree to participate or is unlikely to participate for the entirety of the study
  • Subject is currently participating in another clinical investigation with an active treatment arm

Sites / Locations

  • Fondazione IRCCS Neurologico Carlo BestaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: ExAblate 4000 System

Arm Description

Exablate treatment on Neuropathic Pain

Outcomes

Primary Outcome Measures

Performance Assessment-Pain Numeric Rating Scale
Assessing the change from baseline to 3 months post Exablate treatment for pain intensity defined as a decrease of at least 30% of pain on the Numeric Rating Scale (NRS). On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain. The questionnaire with higher score indicates a higher pain level.
Performance Assessment-Pain Numeric Rating Scale
Assessing the change from baseline to 6-12 months post Exablate treatment for pain intensity assessed by using the pain Numeric Rating Scale (NRS). On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain. The questionnaire with higher score indicates a higher pain level.
Pain Disability Index
Change from baseline to 3 months post Exablate treatment for Physical Function/Disability measured using the Pain Disability Index (PDI). On a scale of 0 to 10, with 0 being no disability at all and 10 being the worst disability. The questionnaire evaluates the degree to which aspects of a patient's life are disrupted by pain.
Pain Catastrophizing Scale
Change from baseline to 3 months post Exablate treatment for Emotional Function/Catastrophizing measured using the Pain Catastrophizing Scale (PCS). On a scale of 0 to 4, with 0 being not at all 4 being all the time. PCS questionnaire is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain).
Beck Depression Inventory
Change from baseline to 3 months post Exablate treatment for Emotional Function/Depression using the Beck Depression Inventory (BDI-II). The assessment for detecting and intensity of depression and monitoring change over time after exablate treatment.
PROMIS Global Health Questionnaire
Change from baseline to 3 months post Exablate treatment for Impact of Pain/General Quality of Life measured using the PROMIS Global Health Questionnaire. On a scale of 1 to 5, with 1 being poor and 5 being excellent. PROMIS Global Health is a self-reported questionnaire to assess an individual's physical, mental, and social health.
PROMIS Sleep Disturbance Questionnaire
Change from baseline to 3 months post Exablate treatment for Impact of Pain/Sleep using the PROMIS Sleep Disturbance Questionnaire. On a scale of 1 to 5, with 1 being very good and 5 very poor. PROMIS Sleep Disturbance is a validated, self-reported questionnaire to assess perceptions of sleep quality, sleep depth, and restoration associated with sleep.
Adverse Events
Incidence and frequency of device and procedure related Adverse Events (AEs) in subjects who undergo an Exablate treatment

Secondary Outcome Measures

Full Information

First Posted
November 17, 2020
Last Updated
November 25, 2020
Sponsor
InSightec
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1. Study Identification

Unique Protocol Identification Number
NCT04649554
Brief Title
Study of MRgFUS Exablate Treatment Following the Neuropathic Pain
Official Title
A Post Market Study of Exablate Model 4000 Type 1.0/1.1 Following the Treatment of Neuropathic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 8, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InSightec

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to capture the change in pain intensity, physical/emotional function, and pain impact for patients diagnosed with neuropathic pain who undergo an Exablate treatment.
Detailed Description
The objectives of this study are to capture the change in pain intensity, physical/emotional function, and pain impact for patients diagnosed with neuropathic pain who undergo an Exablate treatment and to capture safety data of the procedure. The safety assessment measure is the incidence and frequency of device and procedure related Adverse Events (AEs) in subjects who undergo an Exablate treatment. Performance will be measure by assessing the change from baseline to 3 months post Exablate treatment for pain intensity defined as a decrease of at least 30% of pain on the Numeric Rating Scale (NRS). Assessing the change from baseline to 6-12 months post Exablate treatment for pain intensity assessed by using the Numeric Rating Scale (NRS)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Peripheral Neuropathic Pain, Trigeminal Pain, Central Neuropathic Pain, MRgFUS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: ExAblate 4000 System
Arm Type
Experimental
Arm Description
Exablate treatment on Neuropathic Pain
Intervention Type
Device
Intervention Name(s)
Exablate treatment
Other Intervention Name(s)
MRgFUS
Intervention Description
Ablation
Primary Outcome Measure Information:
Title
Performance Assessment-Pain Numeric Rating Scale
Description
Assessing the change from baseline to 3 months post Exablate treatment for pain intensity defined as a decrease of at least 30% of pain on the Numeric Rating Scale (NRS). On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain. The questionnaire with higher score indicates a higher pain level.
Time Frame
3 months
Title
Performance Assessment-Pain Numeric Rating Scale
Description
Assessing the change from baseline to 6-12 months post Exablate treatment for pain intensity assessed by using the pain Numeric Rating Scale (NRS). On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain. The questionnaire with higher score indicates a higher pain level.
Time Frame
6-12 months
Title
Pain Disability Index
Description
Change from baseline to 3 months post Exablate treatment for Physical Function/Disability measured using the Pain Disability Index (PDI). On a scale of 0 to 10, with 0 being no disability at all and 10 being the worst disability. The questionnaire evaluates the degree to which aspects of a patient's life are disrupted by pain.
Time Frame
3, 6, 12 Months
Title
Pain Catastrophizing Scale
Description
Change from baseline to 3 months post Exablate treatment for Emotional Function/Catastrophizing measured using the Pain Catastrophizing Scale (PCS). On a scale of 0 to 4, with 0 being not at all 4 being all the time. PCS questionnaire is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain).
Time Frame
3, 6, 12 Months
Title
Beck Depression Inventory
Description
Change from baseline to 3 months post Exablate treatment for Emotional Function/Depression using the Beck Depression Inventory (BDI-II). The assessment for detecting and intensity of depression and monitoring change over time after exablate treatment.
Time Frame
3, 6, 12 Months
Title
PROMIS Global Health Questionnaire
Description
Change from baseline to 3 months post Exablate treatment for Impact of Pain/General Quality of Life measured using the PROMIS Global Health Questionnaire. On a scale of 1 to 5, with 1 being poor and 5 being excellent. PROMIS Global Health is a self-reported questionnaire to assess an individual's physical, mental, and social health.
Time Frame
3, 6, 12 Months
Title
PROMIS Sleep Disturbance Questionnaire
Description
Change from baseline to 3 months post Exablate treatment for Impact of Pain/Sleep using the PROMIS Sleep Disturbance Questionnaire. On a scale of 1 to 5, with 1 being very good and 5 very poor. PROMIS Sleep Disturbance is a validated, self-reported questionnaire to assess perceptions of sleep quality, sleep depth, and restoration associated with sleep.
Time Frame
3, 6, 12 Months
Title
Adverse Events
Description
Incidence and frequency of device and procedure related Adverse Events (AEs) in subjects who undergo an Exablate treatment
Time Frame
0 to 12 months
Other Pre-specified Outcome Measures:
Title
Qualitative Sensory Testing
Description
Change from baseline of Quantitative Sensory Testing. The Quantitative Sensory Testing analyses perception in response to external stimuli of controlled intensity, such as cold, heat and mechanical pain thresholds.
Time Frame
3, 6, 12 Months
Title
Laser Evoked Potentials
Description
Change from baseline of Laser Evoked Potentials. Laser Evoked Potentials are neurophysiological methods used to evaluate the functions of small fiber sensory pathways by using laser thermal, nociceptive stimuli.
Time Frame
3, 6, 12 Months
Title
Pain Location
Description
Change from baseline of Pain Location Map. Pain Location is assessed using a map of the body that is labelled with different numbered quadrants. The subject is asked via interview technique to indicate the area he/she is feeling pain.
Time Frame
3, 6, 12 Months
Title
Patient Global Impression of Change (PGIC)
Description
Change from baseline of Patient Global Impression of Change (PGIC). The measure PGIC reflects a patient's belief about the efficacy of treatment.
Time Frame
3, 6, 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women age 30 years or older Subject has diagnosis of "definite" neuropathic pain (grading system IASP-NeupSIG) Patient has a score of 6 or higher on the Numeric Rating Scale (NRS) Evidence that the subject has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different medication classes Evidence that the subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation Exclusion Criteria: Subject diagnosed with a nociceptive chronic pain syndrome Subject does not agree to participate or is unlikely to participate for the entirety of the study Subject is currently participating in another clinical investigation with an active treatment arm
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khaja Rehman, PhD
Phone
+1 469 607 0497
Email
KhajaR@insightec.com
First Name & Middle Initial & Last Name or Official Title & Degree
Patrice Horwath
Phone
1-469-843-0494
Email
PatriceH@Insightec.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrice Horwath
Organizational Affiliation
InSightec
Official's Role
Study Director
Facility Information:
Facility Name
Fondazione IRCCS Neurologico Carlo Besta
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dott.ssa Lucrezia Immordino
Phone
+39 022394-2400
Email
lucrezia.immordino@istituto-besta.it
First Name & Middle Initial & Last Name & Degree
Grazia Devigili, MD
Phone
+39 022394-2400
Email
grazia.devigili@istituto-besta.it
First Name & Middle Initial & Last Name & Degree
Grazia Devigili, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of MRgFUS Exablate Treatment Following the Neuropathic Pain

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