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Scrambler Trial for Pain in NMOSD

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ClinicalTrials.gov Identifier: NCT03452176
Recruitment Status : Active, not recruiting
First Posted : March 2, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.


Condition or disease Intervention/treatment Phase
Neuromyelitis Optica Device: Scrambler Device: Scrambler Sham Control Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II, Randomized, Single Blind Sham Controlled Trial Investigating Scrambler Therapy for Neuropathic Pain Caused by Neuromyelitis Optica Spectrum Disorder
Actual Study Start Date : February 21, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 30, 2019


Arm Intervention/treatment
Experimental: Scrambler
This arm will receive the Scrambler intervention for 1 hour daily x10 days.
Device: Scrambler
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.
Other Name: CALMARE

Sham Comparator: Sham-Control
This arm will receive the Sham-Control intervention for 1 hour daily x10 days.
Device: Scrambler Sham Control
Sham control should be indistinguishable to the participants from experimental Scrambler therapy.




Primary Outcome Measures :
  1. Acceptability [ Time Frame: 10 days ]
    Will be determined by how many participants say "yes" to the following question, "Would you want to continue the treatment if it were available?"

  2. Feasibility [ Time Frame: 10 days ]
    Adherence to visit schedule will be determined by the percentage of the 10 treatment visits the participants completed.


Secondary Outcome Measures :
  1. Change in Pain Level [ Time Frame: Baseline, 10 days ]
    Change in NRS pain score (score ranges from 1 to 10 with 1 being "No pain" and 10 being "Worst pain") will be calculated by subtracting the patient's Day 10 pain score (end of treatment) from his or her baseline value.

  2. Change in Pain Level [ Time Frame: Baseline, 30 days ]
    Change in NRS pain score (score ranges from 1 to 10 with 1 being "No pain" and 10 being "Worst pain") will be calculated by subtracting the patient's Day 10 pain score (end of treatment) from his or her baseline value.

  3. Change in Pain Level [ Time Frame: Baseline, 90 days ]
    Change in NRS pain score (score ranges from 1 to 10 with 1 being "No pain" and 10 being "Worst pain") will be calculated by subtracting the patient's Day 10 pain score (end of treatment) from his or her baseline value.



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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:

  • 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.

Exclusion Criteria:

  • 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

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): NCT03452176


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Michael Levy, MD, PhD Johns Hopkins University
Study Director: Maureen A Mealy, RN Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03452176     History of Changes
Other Study ID Numbers: IRB00115699
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Neuromyelitis Optica
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