Focused Ultrasound for the Treatment of Neuropathic Pain

Neuropathic Pain Clinical Trial

Official title:

Open Label Study for the Use of Focused Transcranial Ultrasound for Treatment of Neuropathic Pain

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04485208
• Other study ID #: fUS_NeuropathicPain
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 30, 2020
• Est. completion date: December 30, 2025

Study information

• Verified date: September 2022
• Source: Neurological Associates of West Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Device:
• Focused Ultrasound
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.

Locations

Country	Name	City	State
United States	Neurological Associates of West LA	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Neurological Associates of West Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (8)

Cohen SP, Mao J. Neuropathic pain: mechanisms and their clinical implications. BMJ. 2014 Feb 5;348:f7656. doi: 10.1136/bmj.f7656. Review. Erratum in: BMJ. 2014;348:g2323. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Mauguière F, Desmedt JE. Thalamic pain syndrome of Dejérine-Roussy. Differentiation of four subtypes assisted by somatosensory evoked potentials data. Arch Neurol. 1988 Dec;45(12):1312-20. — View 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. Review. — View Citation

Vartiainen N, Perchet C, Magnin M, Creac'h C, Convers P, Nighoghossian N, Mauguière 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Secondary	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.	Post Final Treatment (8 weeks from baseline)
Secondary	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.	Post Final Treatment (8 weeks from baseline)
Secondary	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.	Post Final Treatment (8 weeks from baseline)