Feasibility Study of ExAblate Thalamotomy for Treatment of Chronic Trigeminal Neuropathic Pain

InSightec

Status

Active, not recruiting

Conditions

Trigeminal Neuropathic Pain

Treatments

Device: Transcranial ExAblate

Device: Sham Transcranial ExAblate

Device: Crossover Transcranial Exablate

Study type

Interventional

Funder types

Industry

Identifiers

NCT03309813

NP002

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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 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.