A Feasibility Study of Focused Ultrasound to Perform Bilateral Medial Thalamotomy for the Treatment of Chronic Trigeminal Neuropathic Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Trigeminal Neuropathic Pain
- Sponsor
- InSightec
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Severity of Device and Procedure Related Complications
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Pain Interference Scale 8a v1.0 From the Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pain Inventory(From pre-treatment through 3 months following treatment.)