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High Frequency Impulse Therapy for Neuropathic Pain in NMOSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04614454
Recruitment Status : Not yet recruiting
First Posted : November 4, 2020
Last Update Posted : November 17, 2020
Sponsor:
Collaborator:
Thimble Bioelectronics, Inc.
Information provided by (Responsible Party):
Michael Levy, Harvard Medical School

Brief Summary:
The aim of this study is to determine whether self-administered, at-home use of ENSO therapy, a high frequency impulse neuromodulation device, is an effective, acceptable and feasible method of relief from neuropathic pain among patients with Neuromyelitis optica spectrum disorder (NMOSD).

Condition or disease Intervention/treatment Phase
Neuromyelitis Optica Device: High Frequency Impulse Therapy Device: High Frequency Impulse Therapy - Sham Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized 1:1 to receive treatment daily for 4 consecutive weeks versus sham, followed by an open-label phase for additional 4 consecutive weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Subjects will be randomized to either the intervention or the control group, fitted and trained to use an ENSO device to self-administer treatment for at least one hour each day. The subjects will not know to which arm they are randomized. Neither will the study coordinator or the investigator. Only a 3rd party collaborator will know the assignment scheme and this will be revealed in blocks every time 4 subjects complete the trial.
Primary Purpose: Treatment
Official Title: High Frequency Impulse Therapy for Neuropathic Pain in NMOSD
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : October 31, 2021


Arm Intervention/treatment
Experimental: Experimental arm
Devices will be programmed by our study coordinator to provide a sham signal or the experimental signal. The location of the ENSO device will be determined by the location of the pain with the goal of placing the unit at the top of the dermatological level corresponding to the pain. The study coordinator will assist each subject to place the device appropriately. Treatment will be administered for 1 hour per day for 4 weeks.
Device: High Frequency Impulse Therapy
The ENSO High Frequency Impulse Therapy device is an at-home transcutaneous electrical nerve stimulation unit in that it provides non-invasive transcutaneous electrical impulses to reduce pain. It is a small, wearable device that utilizes both high and low frequencies to create a nerve-block effect based on the same gating theory.
Other Name: Transcutaneous electrical nerve stimulation

Sham Comparator: Sham arm
The sham unit looks identical to the experimental unit. There may be a sensation experienced by subjects with the sham device but it does not deliver an electric current as the experimental units. The study coordinator will assist each subject to place the device appropriately. Treatment will be administered for 1 hour per day for 4 weeks.
Device: High Frequency Impulse Therapy - Sham
This device looks like the experimental device but does not provide the electrical current.
Other Name: Transcutaneous electrical nerve stimulation - Sham




Primary Outcome Measures :
  1. Pain score on the Wang Baker Pain scale [ Time Frame: 4 weeks from baseline to completion of the experimental phase. ]
    The Wang Baker pain scale is an 11 point scale (0-10) that uses faces to assist in the determination of the pain level.


Secondary Outcome Measures :
  1. Pain score on the Wang Baker Pain scale [ Time Frame: 4 weeks from end of the experimental phase to end of the open label phase. ]
    The Wang Baker pain scale is an 11 point scale (0-10) that uses faces to assist in the determination of the pain level.

  2. "Worst" pain score on the Wang Baker Pain scale [ Time Frame: 4 weeks from baseline to completion of the experimental phase. ]
    The Wang Baker pain scale is an 11 point scale (0-10) that uses faces to assist in the determination of the pain level.

  3. Withdrawal from trial [ Time Frame: 4 weeks from baseline to completion of the experimental phase. ]
    The number of patients who withdraw because of poor compliance.

  4. Quality of life survey [ Time Frame: 4 weeks from baseline to completion of the experimental phase. ]
    SF36 quality of life questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 18 years of age or older diagnosed with NMOSD per the 2015 NMOSD criteria
  2. Patients must be positive for the aquaporin-4 antibody in serum.
  3. Presence of persistent neuropathic pain (>3 months) rated at a level of 4 or higher on the Wong-Baker Faces Pain Scale
  4. Patients must be stable in their disease, such that they have had no spinal cord relapses within 6 months prior to enrollment
  5. Patients must be on a stable medication regimen that may include anti-epileptic, antidepressant, or non-steroidal anti-inflammatory medications, with no adjustments to the regimen within 30 days of enrollment
  6. Pain must be localized to a spinal cord lesion
  7. Patient understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form

Exclusion Criteria:

  1. Patients who are cognitively or mentally incompetent
  2. Any of the following: pregnant women, nursing women, women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, abstinence, etc.).
  3. Use of an investigational agent for pain control concurrently or within the past 30 days
  4. History of an allergic reaction or previous intolerance to transcutaneous electronic nerve stimulation or to latex
  5. Patients with implantable drug delivery systems, e.g. Medtronic Synchromed.
  6. Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, cochlear implants, aneurysm clips, vena cava clips and skull plates (Metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed)
  7. Patients with a known history of myocardial infarction or ischemic heart disease within the past six months
  8. Prior celiac plexus block, or other neurolytic pain control treatment, within 1 month
  9. Other identified causes of painful parasthesias existing prior to chemotherapy (e.g., carpal tunnel syndrome, B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy, etc.) that might be responsible for the patient's current neuropathic symptoms
  10. Skin conditions such as open sores that would prevent proper application of the electrodes
  11. Patients with an ongoing concomitant central neurologic disorder or history of epilepsy, brain damage, or symptomatic brain metastases
  12. Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study

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): NCT04614454


Contacts
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Contact: Gabriela M Romanow 617-784-2598 gromanow@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Contact: Gabriela Romanow       gromanow@mgh.harvard.edu   
Sponsors and Collaborators
Harvard Medical School
Thimble Bioelectronics, Inc.
Investigators
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Principal Investigator: Michael Levy, MD, PhD Massachusetts General Hospital
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Responsible Party: Michael Levy, Associate Professor, Harvard Medical School
ClinicalTrials.gov Identifier: NCT04614454    
Other Study ID Numbers: 2020P003301
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Neuralgia
Neuromyelitis Optica
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Myelitis, Transverse
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Demyelinating Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases