High Frequency Impulse Therapy for Neuropathic Pain in NMOSD
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ClinicalTrials.gov Identifier: NCT04614454 |
Recruitment Status :
Not yet recruiting
First Posted : November 4, 2020
Last Update Posted : November 17, 2020
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Condition or disease | Intervention/treatment | Phase |
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Neuromyelitis Optica | Device: High Frequency Impulse Therapy Device: High Frequency Impulse Therapy - Sham | Phase 2 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men and women 18 years of age or older diagnosed with NMOSD per the 2015 NMOSD criteria
- Patients must be positive for the aquaporin-4 antibody in serum.
- Presence of persistent neuropathic pain (>3 months) rated at a level of 4 or higher on the Wong-Baker Faces Pain Scale
- Patients must be stable in their disease, such that they have had no spinal cord relapses within 6 months prior to enrollment
- 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
- Pain must be localized to a spinal cord lesion
- Patient understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form
Exclusion Criteria:
- Patients who are cognitively or mentally incompetent
- 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.).
- Use of an investigational agent for pain control concurrently or within the past 30 days
- History of an allergic reaction or previous intolerance to transcutaneous electronic nerve stimulation or to latex
- Patients with implantable drug delivery systems, e.g. Medtronic Synchromed.
- 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)
- Patients with a known history of myocardial infarction or ischemic heart disease within the past six months
- Prior celiac plexus block, or other neurolytic pain control treatment, within 1 month
- 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
- Skin conditions such as open sores that would prevent proper application of the electrodes
- Patients with an ongoing concomitant central neurologic disorder or history of epilepsy, brain damage, or symptomatic brain metastases
- Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study

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
Contact: Gabriela M Romanow | 617-784-2598 | gromanow@mgh.harvard.edu |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Contact: Gabriela Romanow gromanow@mgh.harvard.edu |
Principal Investigator: | Michael Levy, MD, PhD | Massachusetts General Hospital |
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 |
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 |
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 |