Scrambler Trial for Pain in NMOSD

NCT03452176 | Completed Results DMC FDA Device

• 1 other identifier: IRB00115699
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

A novel technology called Scrambler Therapy is a non-invasive pain modifying technique that utilizes transcutaneous electrical stimulation of C fibers with the intent of re-organizing maladaptive signaling pathways. This neuromodulatory therapy has been investigated for treatment of chronic neuropathic pain in several conditions including chemotherapy-induced peripheral neuropathy, post-herpetic neuralgia and post-surgical neuropathic pain with promising results. Patients report sustained relief after undergoing daily treatment sessions for 10 consecutive weekdays. This study is a randomized single blinded, sham-controlled trial of patients with Neuromyelitis Optica Spectrum Disorder who have central neuropathic pain using Scrambler Therapy added to standardized empiric medications using patient reported outcomes to determine if Scrambler Therapy is a feasible and effective add-on treatment of chronic neuropathic pain. This trial will recruit twenty-two adult patients diagnosed with NMOSD who have chronic neuropathic pain despite empiric treatment with an anti-epileptic, antidepressant, opioid and/or an NSAID medication. Patients will be randomized 1:1 to undergo Scrambler Therapy or blinded sham daily for 10 days. The primary outcomes will be acceptability and feasibility. The secondary outcome will be efficacy measured as a change in pain scores of more than two points recorded daily by the patient using an 11-point visual analog scale; quality of life (QoL), neurologic function, anxiety, depression, sleep disturbance and pain will also be evaluated at baseline, at the end of therapy, and at 4 \& 8 weeks following completion of treatment. Investigators hypothesize that Scrambler Therapy will be an acceptable, feasible and efficacious intervention that significantly reduces pain in patients with neuromyelitis optica spectrum disorder.

Conditions

Neuromyelitis Optica

Outcome Measures

Primary Outcomes (2)

• Acceptability as Assessed by the Number of Participants Responding Yes to a Question

  Will be determined by how many participants say "yes" to the following question, "Would you want to continue the treatment if it were available?"

  10 days

• Feasibility as Assessed by Number of Participants That Completed Treatment Visits

  Adherence to visit schedule will be determined by the number of participants that completed the 10 treatment visits.

  10 days

Secondary Outcomes (3)

• Change in Pain Level

  Baseline, 10 days

• Change in Pain Level

  Baseline, 30 days

• Change in Pain Level

  Baseline, 60 days

Study Arms (2)

Scrambler

EXPERIMENTAL

This arm will receive the Scrambler intervention for 1 hour daily x10 days.

Device: Scrambler

Sham-Control

SHAM COMPARATOR

This arm will receive the Sham-Control intervention for 1 hour daily x10 days.

Device: Scrambler Sham Control

Interventions

Scrambler DEVICE

Scrambler is a non-invasive pain modifying technique that utilizes transcutaneous electrical stimulation of nociceptive fibers with the intent of re-organizing maladaptive signaling pathways which has been investigated for treatment of peripheral neuropathy.

Also known as: CALMARE

Scrambler

Scrambler Sham Control DEVICE

Sham control should be indistinguishable to the participants from experimental Scrambler therapy.

Sham-Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18 years of age or older
• Have the presence of persistent CNP rated at a level of 4 or higher on an 11-point numeric rating scale (NRS); persistent pain is defined as presence for \>3 months
• Patients must be stable in their disease, such that they have had no spinal cord relapses with the last 6 months
• Patients may use any combination of standard of care medications for pain treatment, to include anti-epileptic, antidepressant, opioid or non-steroidal anti-inflammatory medications, with no adjustments to the regimen within 30 days of enrollment.
• Aquaporin-4 (AQP4)-antibody positive or negative, or untested, but otherwise meeting criteria for diagnosis of NMOSD.

You may not qualify if:

• A concomitant diagnosis of peripheral neuropathy
• An ongoing concomitant central neurologic disorder
• Pain that is referable to a spinal cord lesion that starts above the 4th vertebral disc of the cervical spinal cord because FDA device clearance allows for treatment below the neck
• Use of an investigational agent for pain control within 30 days of enrollment
• Pregnant or breastfeeding women
• Those with cognitive or mental incompetency
• Patients with implantable devices

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Mealy MA, Kozachik SL, Cook LJ, Totonis L, Salazar RA, Allen JK, Nolan MT, Smith TJ, Levy M. Scrambler therapy improves pain in neuromyelitis optica: A randomized controlled trial. Neurology. 2020 May 5;94(18):e1900-e1907. doi: 10.1212/WNL.0000000000009370. Epub 2020 Apr 8.

  PMID: 32269109 DERIVED

MeSH Terms

Conditions

Neuromyelitis Optica

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Michael Levy
• Organization: Massachusetts General Hospital

mlevy11@mgh.harvard.edu

617-726-0412

Study Officials

• Michael Levy, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Maureen A Mealy, RN

  Johns Hopkins University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 2, 2018
• Study Start: February 21, 2018
• Primary Completion: August 29, 2019
• Study Completion: August 29, 2019
• Last Updated: May 5, 2020
• Results First Posted: April 17, 2020

Record last verified: 2020-04

Locations

US (1)