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Scrambler Trial for Pain in NMOSD
NA trial testing Scrambler in Neuromyelitis Optica in 22 participants. Completed in 29 August 2019.
| Lead sponsor | Johns Hopkins University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 21 February 2018 |
| Primary completion | 29 August 2019 |
| Estimated completion | 29 August 2019 |
| Sites | 1 location across United States |
Johns Hopkins University
18 and older, any sex, with Neuromyelitis Optica. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Will be determined by how many participants say "yes" to the following question, "Would you want to continue the treatment if it were available?"
| Group | Value | 95% CI |
|---|---|---|
| Scrambler | 7 | |
| Sham-Control | 5 |
Adherence to visit schedule will be determined by the number of participants that completed the 10 treatment visits.
| Group | Value | 95% CI |
|---|---|---|
| Scrambler | 11 | |
| Sham-Control | 9 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Scrambler Pre | 5.0 | 4.25 – 7.0 |
| Scrambler Post | 1.5 | 0 – 2.75 |
| Sham Pre | 5.0 | 4.0 – 7.25 |
| Sham Post | 4.0 | 3.5 – 4.75 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Scrambler 30-day Post | 4.5 | 3.375 – 5.125 |
| Sham 30-day Post | 5.0 | 4.25 – 6.0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Scrambler 60-day Post | 4.5 | 2.5 – 5.75 |
| Sham 60-day Post | 5.0 | 4.5 – 6.5 |
Time frame: 60 days. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Scrambler | Sham-Control |
|---|---|---|---|
| Urinary tract infection | Renal and urinary disorders | — | — |
| Charles Bonnet Syndrome | Nervous system disorders | — | — |
| Insomnia | Nervous system disorders | — | — |
| Skin sensitivity to electrodes | Skin and subcutaneous tissue disorders | — | — |
| Bacteremia | Infections and infestations | — | — |
Data from ClinicalTrials.gov NCT03452176 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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