Study of MRgFUS Exablate Treatment Following the Neuropathic Pain

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04649554
• Other study ID #: NP003
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2020
• Source: InSightec
• Contact: Khaja Rehman, PhD
• Phone: +1 469 607 0497
• Email: KhajaR[@]insightec.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Device:
• Exablate treatment
Ablation

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Neurologico Carlo Besta	Milano

Sponsors (1)

Lead Sponsor	Collaborator
InSightec

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Adverse Events	Incidence and frequency of device and procedure related Adverse Events (AEs) in subjects who undergo an Exablate treatment	0 to 12 months