- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04485208
Focused Ultrasound for the Treatment of Neuropathic Pain
September 26, 2022 updated by: Neurological Associates of West Los Angeles
Open Label Study for the Use of Focused Transcranial Ultrasound for Treatment of Neuropathic Pain
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Santa Monica, California, United States, 90403
- Neurological Associates of West LA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Pain Inventory (BPI)
Time Frame: 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.
|
Baseline
|
Numeric Pain Rating Scale (NPRS)
Time Frame: 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.
|
Baseline
|
Patient Health Questionnaire (PHQ-9)
Time Frame: 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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Pain Inventory (BPI)
Time Frame: 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.
|
Post Final Treatment (8 weeks from baseline)
|
Numeric Pain Rating Scale (NPRS)
Time Frame: 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.
|
Post Final Treatment (8 weeks from baseline)
|
Patient Health Questionnaire (PHQ-9)
Time Frame: 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.
|
Post Final Treatment (8 weeks from baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2020
Primary Completion (Anticipated)
June 30, 2025
Study Completion (Anticipated)
December 30, 2025
Study Registration Dates
First Submitted
July 21, 2020
First Submitted That Met QC Criteria
July 21, 2020
First Posted (Actual)
July 24, 2020
Study Record Updates
Last Update Posted (Actual)
September 28, 2022
Last Update Submitted That Met QC Criteria
September 26, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- fUS_NeuropathicPain
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neuropathic Pain
-
University Hospital, Clermont-FerrandFondation ApicilCompletedNeuropathic Traumatic Pain | Pain NRS ≥ 4 | Peripheral Neuropathic Pain | Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4France
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedPostherpetic Neuralgia (PHN) | Chemotherapy Induced Neuropathic Pain | Diabetic Peripheral Neuropathic Pain (DPN) | HIV-related Neuropathic Pain (HIV)Colombia, Mexico, Ecuador, Peru, Venezuela
-
University Malaysia SarawakPersatuan Diabetes MalaysiaCompletedNeuropathic Pain, Nociceptive PainMalaysia
-
University Hospital, Clermont-FerrandRecruitingPeripheral Neuropathic PainFrance
-
Daiichi Sankyo Co., Ltd.CompletedCentral Neuropathic PainJapan, Korea, Republic of, Taiwan
-
Hospices Civils de LyonCompletedPharmacoresistant Neuropathic PainFrance
-
Yuhan CorporationCompletedPeripheral Neuropathic PainKorea, Republic of
-
University Hospital, Clermont-FerrandCompletedNeuropathic Pain RebelFrance
-
University Hospital, Strasbourg, FranceTerminatedPostthoracotomy Pain | Postthoracoscopy Neuropathic PainFrance
-
AstraZenecaCompletedNociceptive Pain | Peripheral Neuropathic PainUnited Kingdom
Clinical Trials on Focused Ultrasound
-
Shufang ChangRecruitingCervical Intraepithelial NeoplasiaChina
-
University of California, Los AngelesNational Institute on Aging (NIA)RecruitingMild Cognitive Impairment | Deep Brain Stimulation | Amnestic Mild Cognitive Disorder | Mild Alzheimer's DiseaseUnited States
-
Virginia Polytechnic Institute and State UniversitySalem VA Medical Center; Washington DC VA Medical CenterNot yet recruitingChronic Pain | Opioid Use Disorder | Anxiety DisorderUnited States
-
Virginia Polytechnic Institute and State UniversityEnrolling by invitation
-
University of California, San FranciscoCompletedUterine FibroidsUnited States
-
Marc Dall'Era, MDNational Cancer Institute (NCI)RecruitingLocalized Prostate Carcinoma | Stage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8United States
-
Chongqing Medical UniversityRecruitingThe Therapeutic Effect of Low-intensity Focused Ultrasound on Painful Diabetic Peripheral NeuropathyPainful Diabetic NeuropathyChina
-
Philips HealthcareCompletedSecondary Malignant Neoplasm of BoneFrance
-
Virginia Polytechnic Institute and State UniversityNot yet recruiting
-
Medical University of South CarolinaNot yet recruiting