Feasibility Study of ExAblate Thalamotomy for Treatment of Chronic Trigeminal Neuropathic Pain (NCT03309813) | Clinical Trial Compass
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Feasibility Study of ExAblate Thalamotomy for Treatment of Chronic Trigeminal Neuropathic Pain
United States10 participantsStarted 2017-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 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, 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.
Exclusion Criteria:
* 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:
* 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 ye…
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
1
Severity of Device and Procedure Related Complications
Timeframe: At the time of ExAblate Transcranial thalamotomy procedure through 3-months post-thalamotomy
2
Numeric Pain Rating Scale (NPRS)
Timeframe: Percent Change in NPRS from before treatment to 3 Months following treatment.