Study of MRgFUS Exablate Treatment Following the Neuropathic Pain

NCT04649554 | Terminated

• 1 other identifier: NP003
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain

Keywords

Peripheral Neuropathic Pain; Trigeminal Pain; Central Neuropathic Pain; MRgFUS

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (4)

• Qualitative Sensory Testing

  3, 6, 12 Months

• Laser Evoked Potentials

  3, 6, 12 Months

• Pain Location

  3, 6, 12 Months

Study Arms (1)

Experimental: ExAblate 4000 System

EXPERIMENTAL

Exablate treatment on Neuropathic Pain

Device: Exablate treatment

Interventions

Exablate treatment DEVICE

Ablation

Also known as: MRgFUS

Experimental: ExAblate 4000 System

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InSightec: lead

Study Sites (1)

Fondazione IRCCS Neurologico Carlo Besta

Milan, 20133, Italy

Location

MeSH Terms

Conditions

Neuralgia; Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases

Study Officials

• Patrice Horwath

  InSightec

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 2, 2020
• Study Start: October 8, 2020
• Primary Completion: December 31, 2021
• Study Completion: August 3, 2023
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)