Neuropathic PainNCT04649554
Study of MRgFUS Exablate Treatment Following the Neuropathic Pain
A study testing Exablate treatment in people with Neuropathic Pain, run by InSightec at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Exablate treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteItaly
- Study dates
- 8 Oct 2020to 3 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post Market Study of Exablate Model 4000 Type 1.0/1.1 Following the Treatment of Neuropathic Pain
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.
Read the 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)
- Conditions
- Neuropathic Pain
- Being tested
- Exablate treatment
- Keywords
- Peripheral Neuropathic Pain, Trigeminal Pain, Central Neuropathic Pain, MRgFUS
- Medical subject headings
- Neuralgia, Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exablate treatmentDevice
Also called MRgFUS
Ablation
| Study group | Role | What they receive |
|---|---|---|
| Experimental: ExAblate 4000 System | Experimental | Exablate treatment on Neuropathic Pain Receives: Device: Exablate treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3, 6, 12 Months
Adverse Events
Incidence and frequency of device and procedure related Adverse Events (AEs) in subjects who undergo an Exablate treatment
Measured: 0 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start8 Oct 2020
- Primary completion31 Dec 2021
- Study completion3 Aug 2023
Why it stopped: Study closed by the Sponsor, due to low enrollment during COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by InSightecThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrice Horwath, Study director, InSightec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649554
- Sponsor's protocol ID
- NP003
- Status last verified
- Mar 2026
- First submitted
- 17 Nov 2020
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Study of Exablate Model 4000 Type 1.0/1.1 Following the Treatment of Neuropathic Pain
- ClinicalTrials.gov ID
- NCT04649554
- Acronym / sponsor ID
- NP003
- Conditions
- Neuropathic Pain
- Keywords
- Peripheral Neuropathic Pain, Trigeminal Pain, Central Neuropathic Pain, MRgFUS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed by the Sponsor, due to low enrollment during COVID
- Enrolment
- 2 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: ExAblate 4000 System | Experimental | Device: Exablate treatmentExablate treatment on Neuropathic Pain |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exablate treatmentAlso: MRgFUSAblation | Device | Experimental: ExAblate 4000 System |
Primary outcome
Performance Assessment-Pain Numeric Rating Scale
Time frame: 3 months
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.
Performance Assessment-Pain Numeric Rating Scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 0 to 12 months
Incidence and frequency of device and procedure related Adverse Events (AEs) in subjects who undergo an Exablate treatment
Results and safety
The study was stopped early (reason given: Study closed by the Sponsor, due to low enrollment during COVID). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrice Horwath study director
InSightec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exablate treatment in people with Neuropathic Pain, run by InSightec at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study closed by the Sponsor, due to low enrollment during COVID). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Assessment-Pain Numeric Rating Scale (time frame: 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.