Trigeminal Neuropathic PainNCT03309813
Feasibility Study of ExAblate Thalamotomy for Treatment of Chronic Trigeminal Neuropathic Pain
A study testing Transcranial ExAblate and Crossover Transcranial Exablate in people with Trigeminal Neuropathic Pain, run by InSightec at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Trigeminal Neuropathic Pain
- What is being tested?
- Transcranial ExAblate and Crossover Transcranial Exablate
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, between 18 and 75 years, inclusive
- Subjects who are able and willing to give consent and able to attend all study visits
- Severe chronic, trigeminal neuropathic pain of ≥6 months duration.
- Pain is medication-refractory to adequate trials of at least 3 prescription medications commonly used for symptomatic relief of neuropathic pain with current adjunctive use of at least one medication. An adequate medication trial is defined as a therapeutic dose of each medication without sufficient effect.
- Pain is treatment-resistant to at least one interventional therapies including injections, procedures, neuromodulation, and surgery.
- Able to communicate sensations during the focused ultrasound treatment
- Stable prescribed doses of all symptomatic pain medications for 30 days prior to study entry and for the duration of the 3-month blinded phase of the study.
Who cannot join
- Craniofacial pain syndromes related to malignancy of the head and neck
- Idiopathic trigeminal neuralgia
- Headache syndromes like migraine, cluster headache
- Temporomandibular joint syndrome
- Atypical facial pain or pain related to a somatoform disorder
- Subjects with active psychiatric illness will be excluded. For the purpose of this study, active psychiatric illness includes:
Show all 33Show fewer
- Exhibiting current suicide ideation and/or a history of suicide attempt within past 2 years
- been hospitalized for the treatment of a psychiatric illness within the past 2 years
- received transcranial magnetic stimulation for depression treatment
- received electroconvulsive therapy for depression
- Any presence or history of psychosis will be excluded.
- Subjects with unstable cardiac status including:
- Unstable angina pectoris on medication
- Subjects with documented myocardial infarction within six months of protocol entry
- Significant congestive heart failure defined with ejection fraction < 40
- Subjects with unstable ventricular arrhythmias
- Subjects with atrial arrhythmias that are not rate-controlled
- Severe hypertension (diastolic BP > 100 on medication)
- Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hours of total table time.)
- Subjects participating or have participated in another clinical trial in the last 30 days
- Presence of systemic neurological disease or dysfunction
- Known life-threatening systemic disease
- Subjects with brain tumors or any significant intracranial mass. Trigeminal or cavernous sinus tumors causing neuropathic pain are not excluded.
- Pregnancy or lactation
- Legal incapacity or limited legal capacity
- Subjects with a deep brain stimulation implant or with a prior stereotactic thalamic ablation
- History of hemorrhagic stroke or cerebrovascular event within the past year of treatment exhibiting incomplete resolution
- History of seizures within past year of treatment
- Severe kidney disease or on dialysis
- Subjects who are unable to tolerate medications due to intolerable side effects.
- Subjects with pain other than craniofacial neuropathic pain.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: A Feasibility Study of Focused Ultrasound to Perform Bilateral Medial Thalamotomy for the Treatment of Chronic Trigeminal Neuropathic Pain
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.
Read the detailed description
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.
- Conditions
- Trigeminal Neuropathic Pain
- Being tested
- Transcranial ExAblate, Sham Transcranial ExAblate, Crossover Transcranial Exablate
- Keywords
- ExAblate, TcMRgFUS, Thalamotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial ExAblateDevice
Also called MRgFUS, Thalamotomy
ExAblate Thalamotomy for Chronic Trigeminal Neuropathic Pain
Sham Transcranial ExAblateDevice
Sham ExAblate Thalamotomy procedure
Crossover Transcranial ExablateDevice
Also called MRgFUS, Thalamotomy
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial ExAblate | Experimental | ExAblate Transcranial MR Guided Focused Ultrasound (MRgFUS) Receives: Device: Transcranial ExAblate |
| Sham Transcranial ExAblate | Sham comparator | ExAblate MRgFUS Sham Procedure Receives: Device: Sham Transcranial ExAblate; Device: Crossover Transcranial Exablate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Percent Change in NPRS from before treatment to 3 Months following treatment.
Secondary outcomes (1)
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.
Measured: From pre-treatment through 3 months following treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start1 Dec 2017
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trigeminal 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
- Randomised
- Intervention model
- Sequential
- Model description
- Subjects were randomized to an Exablate Test Arm or a Sham Control Arm. After completing the Month 3 Sham study visit, Sham Controls could elect to receive the actual Exablate ablation (same as test arm) and continue follow-up in a "Crossover Arm."
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William J Elias, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309813
- Sponsor's protocol ID
- NP002
- Status last verified
- Dec 2022
- First submitted
- 5 Oct 2017
- Last updated
- 3 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Ishaque M, Moosa S, Urban L, Kundu B, Qureshi Z, Spears T, Fletcher PT, Donahue J, Patel SH, Goldstein RB, Finan PH, Liu CC, Elias WJ. Bilateral focused ultrasound medial thalamotomies for trigeminal neuropathic pain: a randomized controlled study. J Neurosurg. 2023 Dec 29;140(6):1799-1809. doi: 10.3171/2023.10.JNS23661. Print 2024 Jun 1.
PubMed 38157521
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Focused Ultrasound to Perform Bilateral Medial Thalamotomy for the Treatment of Chronic Trigeminal Neuropathic Pain
- ClinicalTrials.gov ID
- NCT03309813
- Acronym / sponsor ID
- NP002
- Conditions
- Trigeminal Neuropathic Pain
- Keywords
- ExAblate, TcMRgFUS, Thalamotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 16 Oct 2017 (actual)
- Results
- Posted 3 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects were randomized to an Exablate Test Arm or a Sham Control Arm. After completing the Month 3 Sham study visit, Sham Controls could elect to receive the actual Exablate ablation (same as test arm) and continue follow-up in a "Crossover Arm."
| Arm | Type | Receives |
|---|---|---|
| Transcranial ExAblate | Experimental | Device: Transcranial ExAblateExAblate Transcranial MR Guided Focused Ultrasound (MRgFUS) |
| Sham Transcranial ExAblate | Sham comparator | Device: Sham Transcranial ExAblate, Device: Crossover Transcranial ExablateExAblate MRgFUS Sham Procedure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women, between 18 and 75 years, inclusive
- Subjects who are able and willing to give consent and able to attend all study visits
- Severe chronic, trigeminal neuropathic pain of ≥6 months duration.
- Pain is medication-refractory to adequate trials of at least 3 prescription medications commonly used for symptomatic relief of neuropathic pain with current adjunctive use of at least one medication. An adequate medication trial is defined as a therapeutic dose of each medication without sufficient effect.
- Pain is treatment-resistant to at least one interventional therapies including injections, procedures, neuromodulation, and surgery.
Key exclusion criteria (33 listed)
- Craniofacial pain syndromes related to malignancy of the head and neck
- Idiopathic trigeminal neuralgia
- Headache syndromes like migraine, cluster headache
- Temporomandibular joint syndrome
- Atypical facial pain or pain related to a somatoform disorder
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 |
|---|---|---|
| Transcranial ExAblateAlso: MRgFUS, ThalamotomyExAblate Thalamotomy for Chronic Trigeminal Neuropathic Pain | Device | Transcranial ExAblate |
| Sham Transcranial ExAblateSham ExAblate Thalamotomy procedure | Device | Sham Transcranial ExAblate |
| Crossover Transcranial ExablateAlso: MRgFUS, ThalamotomySubjects 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. | Device | Sham Transcranial ExAblate |
Primary outcome
Severity of Device and Procedure Related Complications
Time frame: At the time of ExAblate Transcranial thalamotomy procedure through 3-months post-thalamotomy
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.
Numeric Pain Rating Scale (NPRS)
Time frame: Percent Change in NPRS from before treatment to 3 Months following treatment.
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).
1 secondary outcome
Pain Interference Scale 8a v1.0 From the Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pain Inventory
Time frame: From pre-treatment through 3 months following treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38157521Ishaque M, Moosa S, Urban L, Kundu B, Qureshi Z, Spears T, Fletcher PT, Donahue J, Patel SH, Goldstein RB, Finan PH, Liu CC, Elias WJ. Bilateral focused ultrasound medial thalamotomies for trigeminal neuropathic pain: a randomized controlled study. J Neurosurg. 2023 Dec 29;140(6):1799-1809. doi: 10.3171/2023.10.JNS23661. Print 2024 Jun 1.
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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.
William J Elias, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial ExAblate and Crossover Transcranial Exablate in people with Trigeminal Neuropathic Pain, run by InSightec at 1 site in United States.
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 7 inclusion and 33 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: status not confirmed, as of the sponsor's last update on 3 Oct 2023. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 3 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Severity of Device and Procedure Related Complications (time frame: At the time of ExAblate Transcranial thalamotomy procedure through 3-months post-thalamotomy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03309813, which also lists 1 linked publication.
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 3 Oct 2023.