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Focused Ultrasound Treatment of Stump Neuromas for the Relief of Chronic Post-Amputation Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT03255395
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Eisenberg Elon MD, Rambam Health Care Campus

Study Description
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Brief Summary:

AIM: To provide initial information on the efficacy (pain reduction) and safety of focused ultrasound surgery for the ablation of stump neuromas in amputees with chronic neuropathic pain.

PARTICIPANTS: The study will include 10 amputees (men/women age >18 years old) with chronic (>3 months) phantom/residual limb pain (NPS ≥ 4).

DESIGN: Patients potentially qualifying for the study will be offered an Informed Consent to sign prior to further evaluation. Those who accept will sign the informed consent, complete study questionnaires and be evaluated in terms of inclusion/exclusion criteria. Specifically, a complete medical history will be obtained to determine the patient's general health status, current symptoms, frequency and dosage of their current analgesic intake etc. Baseline pain scores will be established. If not performed within six months prior to the evaluation, a contrast MRI of the stump will be performed. Patients not meeting the study criteria will be exited from the study as screen failures and not be included in analyses. All qualifying patients will complete a baseline MRI exam on treatment day. Any patient not meeting study criteria at Imaging will be exited as screen failures.

After completion of the MRI exam, qualifying patients will proceed to the ExAblate treatment. These patients will then be followed for 6-months post-ExAblate treatment; the patients will complete study follow-up questionnaires at 1, 3 days, 1 and 2 weeks, and 1, 3 and 6 months after treatments. Follow-up visits will take place 1 week and 1, 3 and 6 months after treatment to assess their pain status, their quality of life and safety. Data regarding dosage and frequency of analgesic intake for the management of post amputation NP will be collected. Relevant cost data will be collected in order to enable an assessment of the total cost of the procedure.


Condition or disease Intervention/treatment Phase
Phantom Limb Pain Residual Limbs Amputation Device: Magnetic resonance-guided focused ultrasound Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A single group feasibility study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Focused Ultrasound Treatment of Stump Neuromas for the Relief of Chronic Post-Amputation Neuropathic Pain
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Magnetic resonance-guided focused ultrasound (MRgFUS)
Ten amputees will recieve magnetic resonance-guided focused ultrasound (MRgFUS) treatment aimed to ablate neromas, which are beleived to cuase phantom / residual limb pain
 Device: Magnetic resonance-guided focused ultrasound
Ten amputees wil recieve a magnetic resonance-guided focused ultrasound treatment aimed at ablating neuromas, which are believe to contribute to their phantom / residual limb pain


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in the average daily pain [ Time Frame: Up to 6 months ]
    Change from baseline in the average daily pain intensity, measured for 3 consecutive days, on the Numerical Pain Scale (NPS), an 11-point numeric rating scale.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women amputees, aged 18 and older
  2. Patients who are able and willing to give consent and able to attend all study visits
  3. Patients who are suffering from post-amputation phantom/residual limb pain for at least 3 months
  4. Patient with average pain intensity on a 0-10 numerical pain scale (NPS) ≥ 4 during a 3 days period prior to enrollment irrespective of medication use
  5. Patient whose targeted (treated) lesion is deeper than 10-mm from the skin
  6. Targeted (treated) neuroma is clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible

Exclusion Criteria:

  1. Patients with any acute or unstable medical condition (e.g., infection, cardiac condition, uncontrolled diabetes mellitus, uncontrolled hypertension) that is expected to hinder them from completing this study
  2. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (weight >250 pounds (113kg), etc.
  3. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
  4. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 3 hrs.)
  5. Are participating or have participated in another clinical trial in the last 30 days
  6. Patients with persistent undistinguishable pain (pain source unidentifiable)
  7. Patients whose neuroma is < 10-mm from the skin, blood vessels or bone
  8. Patients with more than three neuromas in the affected limb
  9. Targeted (treated) neuroma is NOT visible by non-contrast MRI
  10. Targeted neuroma is not accessible to ExAblate due to scar tissue or any other reason
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255395


Contacts
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Contact: Elon Eisenberg, Prof 972-4-7771931 e_eisenberg@rambam.health.gov.il

Locations
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Israel
Rambam Health Care Campus Recruiting
Haifa, Israel
Principal Investigator: Elon Eisenberg         
Sponsors and Collaborators
Rambam Health Care Campus
More Information
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Responsible Party: Eisenberg Elon MD, Head, Pain Research Unit, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03255395     History of Changes
Other Study ID Numbers: 180-16
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eisenberg Elon MD, Rambam Health Care Campus:
MRI
Ultrasound
Phantom Limb Pain
Residual Limb Pain
Neuroma
Additional relevant MeSH terms:
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Neuroma
Neuralgia
Phantom Limb
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
 Perceptual Disorders
Neurobehavioral Manifestations
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms