TerminatedNot Applicable

Study of MRgFUS Exablate Treatment Following the Neuropathic Pain

Stopped: Study closed by the Sponsor, due to low enrollment during COVID

Italy2 participantsStarted 2020-10-08

Plain-language 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.

Who can participate

Age range

30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Performance Assessment-Pain Numeric Rating Scale

Timeframe: 3 months

Performance Assessment-Pain Numeric Rating Scale

Timeframe: 6-12 months

Pain Disability Index

Timeframe: 3, 6, 12 Months

Pain Catastrophizing Scale

Timeframe: 3, 6, 12 Months

Beck Depression Inventory

Timeframe: 3, 6, 12 Months

PROMIS Global Health Questionnaire

Timeframe: 3, 6, 12 Months

PROMIS Sleep Disturbance Questionnaire

Timeframe: 3, 6, 12 Months

Adverse Events

Timeframe: 0 to 12 months

Trial details

NCT IDNCT04649554

SponsorInSightec

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-31

View on ClinicalTrials.gov More Neuropathic Pain trials

Who can participate

Age range

30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Performance Assessment-Pain Numeric Rating Scale

Timeframe: 3 months

Performance Assessment-Pain Numeric Rating Scale

Timeframe: 6-12 months

Pain Disability Index

Timeframe: 3, 6, 12 Months

Pain Catastrophizing Scale

Timeframe: 3, 6, 12 Months

Beck Depression Inventory

Timeframe: 3, 6, 12 Months

PROMIS Global Health Questionnaire

Timeframe: 3, 6, 12 Months

PROMIS Sleep Disturbance Questionnaire

Timeframe: 3, 6, 12 Months

Adverse Events

Timeframe: 0 to 12 months