Focused Ultrasound for the Treatment of Neuropathic Pain
- Conditions
- Neuropathic Pain
- Interventions
- Device: Focused Ultrasound
- Registration Number
- NCT04485208
- Lead Sponsor
- Neurological Associates of West Los Angeles
- Brief Summary
A possible treatment approach for neuropathic pain would employ a process designed to promote healthier function of the ventral posteromedial (VPM) and ventral posterolateral (VPL) thalamic nuclei. This study is designed to employ focused ultrasound technology to target the VPM and VPL thalamus among participants with ongoing neuropathic pain syndromes to evaluate for tolerability and early efficacy.
- Detailed Description
The present open-label study is being undertaken to evaluate focused transcranial ultrasound therapy as an intervention for patients with neuropathic pain. The subjects in this research study will be recruited through medical practice. Participants who are enrolled will undergo 8 consecutive weekly ultrasound sessions. Targeting for treatment will be based on patient MRI scans using stereotaxic techniques.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 40
- History of neuropathic pain (onset, location, intensity, duration, quality, aggravating factors)
- Confirmation of nervous system injury through imaging or negative or positive sensory signs confined to the corresponding bodily area
- Failure from at least 3 pharmacological treatments (e.g., antidepressants, anticonvulsants, opioids)
- At least 18 years of age
- Subjects unable to give informed consent
- Subjects who would not be able to lay down without excessive movement in a calm environment
- Pregnancy, women who may become pregnant or are breastfeeding
- Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Active Focused Ultrasound Patients will undergo ten to thirty minutes of transcranial ultrasound treatment. The sonification device will be aimed at the thalamus. Targeting will include reference to scalp fiducials based on the obtained MRI; confirmation of target accuracy will either be obtained by Doppler waveform confirmation or optical tracking technology which co-registers patient neuroimaging with real space.
- Primary Outcome Measures
Name Time Method Numeric Pain Rating Scale (NPRS) Baseline The NRPS is a unidimensional measure of pain intensity for adults. The 11-point numeric scale ranges from '0' representing 'no pain' to 10 representing 'worst possible pain.' The NPRS can be administered verbally or graphically for self-completion. The respondent is asked to indicate the numeric scale value that best describes the intensity of their pain within the last 24-hours. Clinical improvement is denoted by at least 3 points improvement.
Brief Pain Inventory (BPI) Baseline Self-report measure containing a composite pain score and functional interference score. The pain subscale contains 4 questions, each with answers ranging from 0 'no pain' to 10 'pain as bad as you can imagine.' Total possible score for the pain subscale is 40 points. The functional/interference subscale contains 7 questions, with each answer ranging from 0 'does not interfere' to 10 'completely interferes.' The maximum possible score for the interference subscale is 70 points. The total overall composite BPI score is out of 100 maximum points. A clinical improvement is considered a decrease in BPI overall composite score by at least 30% from baseline.
Patient Health Questionnaire (PHQ-9) Baseline The PHQ-9 is a 9-item, self-report questionnaire to evaluate for depressive symptoms. Each question asks the patient if they have experienced a particular depressive symptom over the past two weeks. Answers may range from "0" (not at all), "1" (several days/week), "2" (more than half of the days), and "3" (nearly every day). Maximum total score is 27 points. A higher score indicates more severe depressive symptoms. A reduction in total score by at least 30% is considered clinically meaningful.
- Secondary Outcome Measures
Name Time Method Brief Pain Inventory (BPI) Post Final Treatment (8 weeks from baseline) Self-report measure containing a composite pain score and functional interference score. The pain subscale contains 4 questions, each with answers ranging from 0 'no pain' to 10 'pain as bad as you can imagine.' Total possible score for the pain subscale is 40 points. The functional/interference subscale contains 7 questions, with each answer ranging from 0 'does not interfere' to 10 'completely interferes.' The maximum possible score for the interference subscale is 70 points. The total overall composite BPI score is out of 100 maximum points. A clinical improvement is considered a decrease in BPI overall composite score by at least 30% from baseline.
Numeric Pain Rating Scale (NPRS) Post Final Treatment (8 weeks from baseline) The NRPS is a unidimensional measure of pain intensity for adults. The 11-point numeric scale ranges from '0' representing 'no pain' to 10 representing 'worst possible pain.' The NPRS can be administered verbally or graphically for self-completion. The respondent is asked to indicate the numeric scale value that best describes the intensity of their pain within the last 24-hours. Clinical improvement is denoted by at least 3 points improvement.
Patient Health Questionnaire (PHQ-9) Post Final Treatment (8 weeks from baseline) The PHQ-9 is a 9-item, self-report questionnaire to evaluate for depressive symptoms. Each question asks the patient if they have experienced a particular depressive symptom over the past two weeks. Answers may range from "0" (not at all), "1" (several days/week), "2" (more than half of the days), and "3" (nearly every day). Maximum total score is 27 points. A higher score indicates more severe depressive symptoms. A reduction in total score by at least 30% is considered clinically meaningful.
Trial Locations
- Locations (1)
Neurological Associates of West LA
🇺🇸Santa Monica, California, United States