Scrambler Trial for Pain in NMOSD
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|ClinicalTrials.gov Identifier: NCT03452176|
Recruitment Status : Completed
First Posted : March 2, 2018
Last Update Posted : September 2, 2019
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
|Actual Primary Completion Date :||August 29, 2019|
|Actual Study Completion Date :||August 29, 2019|
This arm will receive the Scrambler intervention for 1 hour daily x10 days.
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.
- Acceptability as assessed by the number of participants responding yes to a question [ 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?"
- Feasibility as assessed by percentage of treatment visits completed by participants [ Time Frame: 10 days ]Adherence to visit schedule will be determined by the percentage of the 10 treatment visits the participants completed.
- 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.
- 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.
- 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.
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
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Michael Levy, MD, PhD||Johns Hopkins University|
|Study Director:||Maureen A Mealy, RN||Johns Hopkins University|