Study of MRgFUS Exablate Treatment Following the Neuropathic Pain

Not Applicable

• Conditions: Neuropathic Pain
• Interventions: Device: Exablate treatment

• Registration Number: NCT04649554
• Lead Sponsor: InSightec

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)

Study Timeline

• Study Start: 2020-10-08
• Status Verified: 2020-11
• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-11-25
• Last Update Submitted: 2020-11-25
• Study First Posted: 2020-12-02
• Last Update Posted: 2020-12-02
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: ExAblate 4000 System	Exablate treatment	Exablate treatment on Neuropathic Pain

Primary Outcome Measures

Name	Time	Method
Performance Assessment-Pain Numeric Rating Scale	6-12 months	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	3, 6, 12 Months	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	3, 6, 12 Months	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	3, 6, 12 Months	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	3, 6, 12 Months	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	3, 6, 12 Months	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	0 to 12 months	Incidence and frequency of device and procedure related Adverse Events (AEs) in subjects who undergo an Exablate treatment

Trial Locations

Locations (1)

Fondazione IRCCS Neurologico Carlo Besta; 🇮🇹 Milano, Italy