Study of MRgFUS Exablate Treatment Following the Neuropathic Pain

A Post Market Study of Exablate Model 4000 Type 1.0/1.1 Following the Treatment of Neuropathic Pain

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.

Study Overview

• Status: Unknown
• Conditions: Neuropathic Pain
• Intervention / Treatment: Device: 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)

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khaja Rehman, PhD; Phone Number: +1 469 607 0497; Email: KhajaR@insightec.com
• Study Contact Backup: Name: Patrice Horwath; Phone Number: 1-469-843-0494; Email: PatriceH@Insightec.com

Study Locations

• Italy
  • Milano, Italy, 20133
    • Recruiting
    • Fondazione IRCCS Neurologico Carlo Besta
    • Contact: Dott.ssa Lucrezia Immordino; Phone Number: +39 022394-2400; Email: lucrezia.immordino@istituto-besta.it
    • Contact: Grazia Devigili, MD; Phone Number: +39 022394-2400; Email: grazia.devigili@istituto-besta.it
    • Principal Investigator: Grazia Devigili, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: ExAblate 4000 System; Exablate treatment on Neuropathic Pain	Device: Exablate treatment; Ablation; Other Names: MRgFUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
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.	6-12 months
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.	3, 6, 12 Months
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).	3, 6, 12 Months
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.	3, 6, 12 Months
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.	3, 6, 12 Months
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.	3, 6, 12 Months
Adverse Events	Incidence and frequency of device and procedure related Adverse Events (AEs) in subjects who undergo an Exablate treatment	0 to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative Sensory Testing	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.	3, 6, 12 Months
Laser Evoked Potentials	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.	3, 6, 12 Months
Pain Location	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.	3, 6, 12 Months
Patient Global Impression of Change (PGIC)	Change from baseline of Patient Global Impression of Change (PGIC). The measure PGIC reflects a patient's belief about the efficacy of treatment.	3, 6, 12 Months

Collaborators and Investigators

• Sponsor: InSightec
• Investigators: Study Director: Patrice Horwath, InSightec

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 25, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Central Neuropathic Pain; MRgFUS; Peripheral Neuropathic Pain; Trigeminal Pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: NP003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No