Clinical trial NCT04649554: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Neuropathic Pain
Keywords: Peripheral Neuropathic Pain
Trigeminal Pain
Central Neuropathic Pain
MRgFUS
Lead sponsor: InSightec
Sponsor class: INDUSTRY
First posted: 2020-12-02
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Performance Assessment-Pain Numeric Rating Scale
timeFrame: 3 months
measure: Performance Assessment-Pain Numeric Rating Scale
timeFrame: 6-12 months
measure: Pain Disability Index
timeFrame: 3, 6, 12 Months
measure: Pain Catastrophizing Scale
timeFrame: 3, 6, 12 Months
measure: Beck Depression Inventory
timeFrame: 3, 6, 12 Months
measure: PROMIS Global Health Questionnaire
timeFrame: 3, 6, 12 Months
measure: PROMIS Sleep Disturbance Questionnaire
timeFrame: 3, 6, 12 Months
measure: Adverse Events
timeFrame: 0 to 12 months
Secondary outcomes:
Other outcomes:
measure: Qualitative Sensory Testing
timeFrame: 3, 6, 12 Months
measure: Laser Evoked Potentials
timeFrame: 3, 6, 12 Months
measure: Pain Location
timeFrame: 3, 6, 12 Months
measure: Patient Global Impression of Change (PGIC)
timeFrame: 3, 6, 12 Months
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Neurologico Carlo Besta
Study officials:
affiliation: InSightec
name: Patrice Horwath
role: STUDY_DIRECTOR
References: