An interventional study of Transcranial ExAblate and Sham Transcranial ExAblate in Trigeminal Neuropathic Pain, sponsored by InSightec. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-03.
Sponsored by InSightec · Not applicable, Interventional, and Treatment
Among 291 studies in Neuralgia with a site in United States — 50 open to participants now, 61 under way, 5 of them phase 3. Neuralgia · United States.
Among the 291 studies in Neuralgia with a site in United States, this one is the 214th largest by enrollment of the 261 interventional ones that give a count, is one of 8 that started in 2017, is one of 112 with no phase, and was the 133rd registered.
1,101 studies on the registry are indexed under Neuralgia; 242 are open to participants now.
Browse Neuralgia studies →50 of the 291 studies in Neuralgia with a site in United States are open now. Recruiting first, the newest first:
University of Miami · Sites in United States
Ages 50+
James J. Peters Veterans Affairs Medical Center · Sites in United States
Ages 22+
EicOsis Human Health Inc. · Sites in United States
Ages 18+
Icahn School of Medicine at Mount Sinai · Sites in United States
Ages 18+
Eli Lilly and Company · Sites in United States, Puerto Rico
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 153 Neuralgia studies recruiting now, 77 (50%) set no upper age limit and 44 (29%) stop at 75 or younger; 8 take children under 18; 12 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
291 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 32 · Phase 2 94 · Phase 3 26 · Phase 4 14
First in 1993; this study’s year is marked. 8 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 10 is below the median of 52 across 831 interventional studies indexed under Neuralgia.
Median enrollment 40 across the 261 interventional studies, 53 across the 28 observational. Of the 193 that completed or were terminated, 86 (45%) have results posted.
This tab as a report to print or save as PDF → With an account.
105 of 291 have an industry lead sponsor. The 10 most frequent:
InSightec is the lead sponsor of 84 studies on the registry; 9 are open to participants now.
InSightec has 3 studies filed under Neuralgia — fewer than ten, so there is no comparison to draw.
27 of the studies in Neuralgia with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06696443Phase 3Vertex Pharmaceuticals IncorporatedEvaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN) | 2027-01-25 |
| NCT07231419Phase 3Vertex Pharmaceuticals IncorporatedEvaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy | 2027-04-06 |
| NCT06628908Phase 3Vertex Pharmaceuticals IncorporatedEvaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy | 2027-05-31 |
| NCT06848348Dogwood Therapeutics Inc.Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain | 2026-12 |
| NCT04865679Axogen CorporationTolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends | 2026-12 |
Add all 27 to your calendar (.ics) → With an account.
Among the 291 studies in Neuralgia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this prospective, randomized, sham-controlled, crossover study is to evaluate the safety and feasibility of ExAblate Neuro treatment of chronic trigeminal neuropathic pain.
This study is to show that for patients with treatment-refractory chronic trigeminal neuropathic pain, ExAblate Neuro focused ultrasound (FUS) can safely create lesions bilaterally in the thalamic nuclei to reduce pain and provide functional benefits in daily activities. After informed consent and screening, eligible subjects will be randomized to either an ExAblate treatment or a Sham Control procedure. Subjects who are randomized to Sham Control will undergo the same procedure and follow-up visits through their Month 3 visit. After the Month 3 assessments are complete, all subjects will be un-blinded and those in the Sham treated group will have the option for an actual ExAblate treatment in an un-blinded fashion, as long as they still qualify for ExAblate treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects with active psychiatric illness will be excluded. For the purpose of this study, active psychiatric illness includes:
Subjects with unstable cardiac status including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ExAblate Transcranial MR Guided Focused Ultrasound (MRgFUS)
Device: Transcranial ExAblate
ExAblate MRgFUS Sham Procedure
Device: Sham Transcranial ExAblate · Device: Crossover Transcranial Exablate
ExAblate Thalamotomy for Chronic Trigeminal Neuropathic Pain
Also known as: MRgFUS, Thalamotomy
Sham ExAblate Thalamotomy procedure
Subjects randomized to the Sham Exablate could opt for the Crossovover Transcranial Exablate Arm (Exablate Thalamotomy) after completing the Month 3 visit in the Sham Arm.
Also known as: MRgFUS, Thalamotomy
Severity of Device and Procedure Related Complications
To evaluate the incidence and severity of adverse events associated with ExAblate lesioning of the bilateral medial thalamus for painful neuropathies of the face and head that are severe and treatment-refractory.
Time frame: At the time of ExAblate Transcranial thalamotomy procedure through 3-months post-thalamotomy
Numeric Pain Rating Scale (NPRS)
Numeric Pain Rating Scale (NPRS) change in worst pain experienced over 24 hours before and at 3 months following bilateral FUS medial thalamotomy versus sham procedures was determined from the 11-point numeric pain rating scale with 0 as no pain and 10 the worst pain imaginable. High NPRS scores are worse pain (0 is no pain, 10 is maximum). Percent change from Baseline at Month 3 was calculated as follows: 100\*(NPRS Score at Baseline - NPRS Score at Month 3)/NPRS Score at Baseline. High percent change in NPRS Score from Baseline is better (improved pain).
Time frame: Percent Change in NPRS from before treatment to 3 Months following treatment.
Pain Interference Scale 8a v1.0 From the Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pain Inventory
The Pain Interference 8a v1.0 Scale (Short Form) from the Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pain Inventory is an 8-item patient completed short form with each item on a 5-point scale (0-4). The total score possible ranges from 0-32. The PROMIS pain interference scale measures the degree to which pain interferes with activities of daily living. A high percent change from Baseline at 3 Months post-treatment is better, shows improvement.
Time frame: From pre-treatment through 3 months following treatment.
| Milestone | Transcranial ExAblate (MRgFUS) Only | Sham Transcranial ExAblate First, Then Optional Transcranial Exablate (MRgFUS) |
|---|---|---|
| Started | 5 | 5 |
| Completed | 4 | 5 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Milestone | Transcranial ExAblate (MRgFUS) Only | Sham Transcranial ExAblate First, Then Optional Transcranial Exablate (MRgFUS) |
|---|---|---|
| Started | 0 | 3 |
| Completed | 0 | 3 |
| Not completed | 0 | 0 |
To evaluate the incidence and severity of adverse events associated with ExAblate lesioning of the bilateral medial thalamus for painful neuropathies of the face and head that are severe and treatment-refractory.
Results for this outcome have not been posted.
Numeric Pain Rating Scale (NPRS) change in worst pain experienced over 24 hours before and at 3 months following bilateral FUS medial thalamotomy versus sham procedures was determined from the 11-point numeric pain rating scale with 0 as no pain and 10 the worst pain imaginable. High NPRS scores are worse pain (0 is no pain, 10 is maximum). Percent change from Baseline at Month 3 was calculated as follows: 100\*(NPRS Score at Baseline - NPRS Score at Month 3)/NPRS Score at Baseline. High percent change in NPRS Score from Baseline is better (improved pain).
| Percent change | Transcranial ExAblate (MRgFUS) Only | Sham Transcranial ExAblate First | Optional Crossover Transcranial Exablate (MRgFUS) |
|---|---|---|---|
| Numeric Pain Rating Scale (NPRS) | -9.7 ± 27.4 | 12.9 ± 21.7 | 4.8 ± 8.3 |
The Pain Interference 8a v1.0 Scale (Short Form) from the Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pain Inventory is an 8-item patient completed short form with each item on a 5-point scale (0-4). The total score possible ranges from 0-32. The PROMIS pain interference scale measures the degree to which pain interferes with activities of daily living. A high percent change from Baseline at 3 Months post-treatment is better, shows improvement.
| Percent Change | Transcranial ExAblate | Sham Transcranial ExAblate | CrossoverTranscranial Exablate |
|---|---|---|---|
| Pain Interference Scale 8a v1.0 From the Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pain Inventory | 12.9 ± 28.3 | 16.6 ± 30.5 | 54.7 ± 40.1 |
Collected over Adverse event data were collected though 3 months post-thalamotomy.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Transcranial ExAblate (MRgFUS) | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Sham Transcranial ExAblate First | 0/5 (0%) | 1/5 (20%) | 5/5 (100%) |
| Optional Crossover Transcranial Exablate (MRgFUS) | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Event | Transcranial ExAblate (MRgFUS) | Sham Transcranial ExAblate First | Optional Crossover Transcranial Exablate (MRgFUS) |
|---|---|---|---|
| Worsening painGeneral disorders | 0/5 | 1/5 | 0/3 |
| Event | Transcranial ExAblate (MRgFUS) | Sham Transcranial ExAblate First | Optional Crossover Transcranial Exablate (MRgFUS) |
|---|---|---|---|
| Nausea/vomitingGastrointestinal disorders | 0/5 | 1/5 | 2/3 |
| Transient headacheGeneral disorders | 0/5 | 2/5 | 0/3 |
| Sonication painGeneral disorders | 1/5 | 0/5 | 1/3 |
| Numbness/tinglingGastrointestinal disorders | 0/5 | 1/5 | 1/3 |
| Head painSkin and subcutaneous tissue disorders | 0/5 | 1/5 | 1/3 |
| FatigueGeneral disorders | 1/5 | 0/5 | 0/3 |
| SleepinessGeneral disorders | 1/5 | 0/5 | 0/3 |
| HeadacheGeneral disorders | 1/5 | 0/5 | 0/3 |
| Cold sensationGeneral disorders | 1/5 | 0/5 | 0/3 |
| UnsteadinessMusculoskeletal and connective tissue disorders | 1/5 | 0/5 | 0/3 |
| Age, Continuous(years) | Transcranial ExAblate (MRgFUS) Only | Sham Transcranial ExAblate First, Then Optional Transcranial ExAblate (MRgFUS) | Total |
|---|---|---|---|
| Age | 64.3 ± 8.9 | 59.6 ± 7.9 | 62.0 ± 8.3 |
| Sex: Female, Male(Participants) | Transcranial ExAblate (MRgFUS) Only | Sham Transcranial ExAblate First, Then Optional Transcranial ExAblate (MRgFUS) | Total |
|---|---|---|---|
| Female | 3 | 5 | 8 |
| Male | 2 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Transcranial ExAblate (MRgFUS) Only | Sham Transcranial ExAblate First, Then Optional Transcranial ExAblate (MRgFUS) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 5 | 5 | 10 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Transcranial ExAblate (MRgFUS) Only | Sham Transcranial ExAblate First, Then Optional Transcranial ExAblate (MRgFUS) | Total |
|---|---|---|---|
| United States | 5 | 5 | 10 |
Started Dec 2017 (actual). Primary completion is estimated for Oct 2023, 70 months after the start.
Of 264 interventional studies with no phase under Neuralgia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 70 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.