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Study closed by the Sponsor, due to low enrollment during COVID
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The objective of this study is to capture the change in pain intensity, physical/emotional function, and pain impact for patients diagnosed with neuropathic pain who undergo an Exablate treatment.
The objectives of this study are to capture the change in pain intensity, physical/emotional function, and pain impact for patients diagnosed with neuropathic pain who undergo an Exablate treatment and to capture safety data of the procedure.
The safety assessment measure is the incidence and frequency of device and procedure related Adverse Events (AEs) in subjects who undergo an Exablate treatment.
Performance will be measure by assessing the change from baseline to 3 months post Exablate treatment for pain intensity defined as a decrease of at least 30% of pain on the Numeric Rating Scale (NRS). Assessing the change from baseline to 6-12 months post Exablate treatment for pain intensity assessed by using the Numeric Rating Scale (NRS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: ExAblate 4000 System | Experimental | Exablate treatment on Neuropathic Pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exablate treatment | Device | Ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance Assessment-Pain Numeric Rating Scale | Assessing the change from baseline to 3 months post Exablate treatment for pain intensity defined as a decrease of at least 30% of pain on the Numeric Rating Scale (NRS). On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain. The questionnaire with higher score indicates a higher pain level. | 3 months |
| Performance Assessment-Pain Numeric Rating Scale | Assessing the change from baseline to 6-12 months post Exablate treatment for pain intensity assessed by using the pain Numeric Rating Scale (NRS). On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain. The questionnaire with higher score indicates a higher pain level. | 6-12 months |
| Pain Disability Index | Change from baseline to 3 months post Exablate treatment for Physical Function/Disability measured using the Pain Disability Index (PDI). On a scale of 0 to 10, with 0 being no disability at all and 10 being the worst disability. The questionnaire evaluates the degree to which aspects of a patient's life are disrupted by pain. | 3, 6, 12 Months |
| Pain Catastrophizing Scale | Change from baseline to 3 months post Exablate treatment for Emotional Function/Catastrophizing measured using the Pain Catastrophizing Scale (PCS). On a scale of 0 to 4, with 0 being not at all 4 being all the time. PCS questionnaire is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). | 3, 6, 12 Months |
| Beck Depression Inventory | Change from baseline to 3 months post Exablate treatment for Emotional Function/Depression using the Beck Depression Inventory (BDI-II). The assessment for detecting and intensity of depression and monitoring change over time after exablate treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Sensory Testing | Change from baseline of Quantitative Sensory Testing. The Quantitative Sensory Testing analyses perception in response to external stimuli of controlled intensity, such as cold, heat and mechanical pain thresholds. | 3, 6, 12 Months |
| Laser Evoked Potentials |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrice Horwath | InSightec | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Neurologico Carlo Besta | Milan | 20133 | Italy |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| 3, 6, 12 Months |
| PROMIS Global Health Questionnaire | Change from baseline to 3 months post Exablate treatment for Impact of Pain/General Quality of Life measured using the PROMIS Global Health Questionnaire. On a scale of 1 to 5, with 1 being poor and 5 being excellent. PROMIS Global Health is a self-reported questionnaire to assess an individual's physical, mental, and social health. | 3, 6, 12 Months |
| PROMIS Sleep Disturbance Questionnaire | Change from baseline to 3 months post Exablate treatment for Impact of Pain/Sleep using the PROMIS Sleep Disturbance Questionnaire. On a scale of 1 to 5, with 1 being very good and 5 very poor. PROMIS Sleep Disturbance is a validated, self-reported questionnaire to assess perceptions of sleep quality, sleep depth, and restoration associated with sleep. | 3, 6, 12 Months |
| Adverse Events | Incidence and frequency of device and procedure related Adverse Events (AEs) in subjects who undergo an Exablate treatment | 0 to 12 months |
Change from baseline of Laser Evoked Potentials. Laser Evoked Potentials are neurophysiological methods used to evaluate the functions of small fiber sensory pathways by using laser thermal, nociceptive stimuli. |
| 3, 6, 12 Months |
| Pain Location | Change from baseline of Pain Location Map. Pain Location is assessed using a map of the body that is labelled with different numbered quadrants. The subject is asked via interview technique to indicate the area he/she is feeling pain. | 3, 6, 12 Months |
| Patient Global Impression of Change (PGIC) | Change from baseline of Patient Global Impression of Change (PGIC). The measure PGIC reflects a patient's belief about the efficacy of treatment. | 3, 6, 12 Months |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |