Back to resultsFocused Ultrasound for the Treatment of Neuropathic Pain
Primary Purpose
Neuropathic Pain
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Focused Ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- Neurological Associates of West LA
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active
Arm Description
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.
Outcomes
Primary Outcome Measures
Brief Pain Inventory (BPI)
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)
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)
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
Brief Pain Inventory (BPI)
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)
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)
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.
Full Information
NCT ID
NCT04485208
First Posted
July 21, 2020
Last Updated
September 26, 2022
Sponsor
Neurological Associates of West Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT04485208
Brief Title
Focused Ultrasound for the Treatment of Neuropathic Pain
Official Title
Open Label Study for the Use of Focused Transcranial Ultrasound for Treatment of Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurological Associates of West Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Focused Ultrasound
Intervention Description
The DWL Doppler ultrasound device enables visual and auditory waveform confirmation of the anterior cerebral artery, and optical tracking technology (e.g., AntNeuro Visor2™ system) may be used in tandem with the Brainsonix Pulsar 1002 ultrasound device to track a patient's brain in virtual space as well as their physical location, thereby ensuring accurate placement.
Primary Outcome Measure Information:
Title
Brief Pain Inventory (BPI)
Description
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.
Time Frame
Baseline
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
Baseline
Title
Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Brief Pain Inventory (BPI)
Description
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.
Time Frame
Post Final Treatment (8 weeks from baseline)
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
Post Final Treatment (8 weeks from baseline)
Title
Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
Post Final Treatment (8 weeks from baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheldon Jordan, MD
Organizational Affiliation
Neurological Associates of West Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurological Associates of West LA
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24500412
Citation
Cohen SP, Mao J. Neuropathic pain: mechanisms and their clinical implications. BMJ. 2014 Feb 5;348:f7656. doi: 10.1136/bmj.f7656. Erratum In: BMJ. 2014;348:g2323.
Results Reference
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30558012
Citation
Jang SH, Kim J, Lee HD. Delayed-onset central poststroke pain due to degeneration of the spinothalamic tract following thalamic hemorrhage: A case report. Medicine (Baltimore). 2018 Dec;97(50):e13533. doi: 10.1097/MD.0000000000013533.
Results Reference
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PubMed Identifier
19679277
Citation
Klit H, Finnerup NB, Jensen TS. Central post-stroke pain: clinical characteristics, pathophysiology, and management. Lancet Neurol. 2009 Sep;8(9):857-68. doi: 10.1016/S1474-4422(09)70176-0.
Results Reference
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PubMed Identifier
29089872
Citation
Kramer PR, Strand J, Stinson C, Bellinger LL, Kinchington PR, Yee MB, Umorin M, Peng YB. Role for the Ventral Posterior Medial/Posterior Lateral Thalamus and Anterior Cingulate Cortex in Affective/Motivation Pain Induced by Varicella Zoster Virus. Front Integr Neurosci. 2017 Oct 16;11:27. doi: 10.3389/fnint.2017.00027. eCollection 2017.
Results Reference
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PubMed Identifier
22696587
Citation
Krause T, Brunecker P, Pittl S, Taskin B, Laubisch D, Winter B, Lentza ME, Malzahn U, Villringer K, Villringer A, Jungehulsing GJ. Thalamic sensory strokes with and without pain: differences in lesion patterns in the ventral posterior thalamus. J Neurol Neurosurg Psychiatry. 2012 Aug;83(8):776-84. doi: 10.1136/jnnp-2011-301936. Epub 2012 Jun 13.
Results Reference
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Citation
Mauguiere F, Desmedt JE. Thalamic pain syndrome of Dejerine-Roussy. Differentiation of four subtypes assisted by somatosensory evoked potentials data. Arch Neurol. 1988 Dec;45(12):1312-20. doi: 10.1001/archneur.1988.00520360030007.
Results Reference
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PubMed Identifier
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Citation
Plotkin JL, Goldberg JA. Thinking Outside the Box (and Arrow): Current Themes in Striatal Dysfunction in Movement Disorders. Neuroscientist. 2019 Aug;25(4):359-379. doi: 10.1177/1073858418807887. Epub 2018 Oct 31.
Results Reference
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Citation
Vartiainen N, Perchet C, Magnin M, Creac'h C, Convers P, Nighoghossian N, Mauguiere F, Peyron R, Garcia-Larrea L. Thalamic pain: anatomical and physiological indices of prediction. Brain. 2016 Mar;139(Pt 3):708-22. doi: 10.1093/brain/awv389. Epub 2016 Feb 8.
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Focused Ultrasound for the Treatment of Neuropathic Pain
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