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 range18 Years – 75 Years
SexALL
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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…
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.