Adjunctive tonic motor activation enables opioid reduction for refractory restless legs syndrome: a prospective, open-label, single-arm clinical trial
Abstract Background There is a large population of restless legs syndrome (RLS) patients who are refractory to medication. Whereas experts recommend off-label opioids as an effective long-term treatment for refractory RLS, reducing opioid dose could substantially reduce side effects and risks. Tonic...
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| Format: | Article |
| Language: | English |
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BMC
2023-11-01
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| Series: | BMC Neurology |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12883-023-03462-6 |
| _version_ | 1797452160235995136 |
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| author | Mark J. Buchfuhrer Asim Roy Stephanye Rodriguez Jonathan D. Charlesworth |
| author_facet | Mark J. Buchfuhrer Asim Roy Stephanye Rodriguez Jonathan D. Charlesworth |
| author_sort | Mark J. Buchfuhrer |
| collection | DOAJ |
| description | Abstract Background There is a large population of restless legs syndrome (RLS) patients who are refractory to medication. Whereas experts recommend off-label opioids as an effective long-term treatment for refractory RLS, reducing opioid dose could substantially reduce side effects and risks. Tonic motor activation (TOMAC) is a nonpharmacological therapeutic device indicated for refractory RLS. Here, we investigated if TOMAC could enable opioid dose reduction for refractory RLS. Methods This prospective, open-label, single-arm clinical trial [NCT04698343] enrolled 20 adults taking ≤ 60 morphine milligram equivalents (MMEs) per day for refractory RLS. Participants self-administered 30-min TOMAC sessions bilaterally over the peroneal nerve when RLS symptoms presented. During TOMAC treatment, opioid dose was reduced iteratively every 2–3 weeks until Clinician Global Impression of Improvement (CGI-I) score relative to baseline exceeded 5. Primary endpoint was percent of participants who successfully reduced opioid dose ≥ 20% with CGI-I ≤ 5. Secondary endpoints included mean successful percent opioid dose reduction with CGI-I ≤ 5. Results On average, participants were refractory to 3.2 medications (SD 1.6) and were taking a stable dose of opioids for 5.3 years (SD 3.9). Seventy percent of participants (70%, 14 of 20) successfully reduced opioid dose ≥ 20% with CGI-I ≤ 5. Mean percent opioid dose reduction with CGI-I ≤ 5 was 29.9% (SD 23.7%, n = 20) from 39.0 to 26.8 MME per day. Mean CGI-I score at the reduced dose was 4.0 (SD 1.4), indicating no change to RLS severity. Conclusions For refractory RLS, TOMAC enabled substantial opioid dose reduction without increased RLS symptoms. These results suggest that TOMAC has the potential to reduce the risk profile associated with opioid therapy for refractory RLS. Trial registration ClinicalTrials.gov trial number NCT04698343 registered on January 6, 2021. |
| first_indexed | 2024-03-09T15:04:45Z |
| format | Article |
| id | doaj.art-3fc405dd4b9e435785ecaf3c8bd0b004 |
| institution | Directory Open Access Journal |
| issn | 1471-2377 |
| language | English |
| last_indexed | 2024-03-09T15:04:45Z |
| publishDate | 2023-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Neurology |
| spelling | doaj.art-3fc405dd4b9e435785ecaf3c8bd0b0042023-11-26T13:42:19ZengBMCBMC Neurology1471-23772023-11-0123111110.1186/s12883-023-03462-6Adjunctive tonic motor activation enables opioid reduction for refractory restless legs syndrome: a prospective, open-label, single-arm clinical trialMark J. Buchfuhrer0Asim Roy1Stephanye Rodriguez2Jonathan D. Charlesworth3Stanford University School of MedicineOhio Sleep Medicine InstitutePrivate PracticeDepartment of Clinical Research, Noctrix Health, IncAbstract Background There is a large population of restless legs syndrome (RLS) patients who are refractory to medication. Whereas experts recommend off-label opioids as an effective long-term treatment for refractory RLS, reducing opioid dose could substantially reduce side effects and risks. Tonic motor activation (TOMAC) is a nonpharmacological therapeutic device indicated for refractory RLS. Here, we investigated if TOMAC could enable opioid dose reduction for refractory RLS. Methods This prospective, open-label, single-arm clinical trial [NCT04698343] enrolled 20 adults taking ≤ 60 morphine milligram equivalents (MMEs) per day for refractory RLS. Participants self-administered 30-min TOMAC sessions bilaterally over the peroneal nerve when RLS symptoms presented. During TOMAC treatment, opioid dose was reduced iteratively every 2–3 weeks until Clinician Global Impression of Improvement (CGI-I) score relative to baseline exceeded 5. Primary endpoint was percent of participants who successfully reduced opioid dose ≥ 20% with CGI-I ≤ 5. Secondary endpoints included mean successful percent opioid dose reduction with CGI-I ≤ 5. Results On average, participants were refractory to 3.2 medications (SD 1.6) and were taking a stable dose of opioids for 5.3 years (SD 3.9). Seventy percent of participants (70%, 14 of 20) successfully reduced opioid dose ≥ 20% with CGI-I ≤ 5. Mean percent opioid dose reduction with CGI-I ≤ 5 was 29.9% (SD 23.7%, n = 20) from 39.0 to 26.8 MME per day. Mean CGI-I score at the reduced dose was 4.0 (SD 1.4), indicating no change to RLS severity. Conclusions For refractory RLS, TOMAC enabled substantial opioid dose reduction without increased RLS symptoms. These results suggest that TOMAC has the potential to reduce the risk profile associated with opioid therapy for refractory RLS. Trial registration ClinicalTrials.gov trial number NCT04698343 registered on January 6, 2021.https://doi.org/10.1186/s12883-023-03462-6BioelectronicsNeurological disorderNeuromodulationPeripheral nerve stimulationOpioidsRrestless legs syndrome |
| spellingShingle | Mark J. Buchfuhrer Asim Roy Stephanye Rodriguez Jonathan D. Charlesworth Adjunctive tonic motor activation enables opioid reduction for refractory restless legs syndrome: a prospective, open-label, single-arm clinical trial BMC Neurology Bioelectronics Neurological disorder Neuromodulation Peripheral nerve stimulation Opioids Rrestless legs syndrome |
| title | Adjunctive tonic motor activation enables opioid reduction for refractory restless legs syndrome: a prospective, open-label, single-arm clinical trial |
| title_full | Adjunctive tonic motor activation enables opioid reduction for refractory restless legs syndrome: a prospective, open-label, single-arm clinical trial |
| title_fullStr | Adjunctive tonic motor activation enables opioid reduction for refractory restless legs syndrome: a prospective, open-label, single-arm clinical trial |
| title_full_unstemmed | Adjunctive tonic motor activation enables opioid reduction for refractory restless legs syndrome: a prospective, open-label, single-arm clinical trial |
| title_short | Adjunctive tonic motor activation enables opioid reduction for refractory restless legs syndrome: a prospective, open-label, single-arm clinical trial |
| title_sort | adjunctive tonic motor activation enables opioid reduction for refractory restless legs syndrome a prospective open label single arm clinical trial |
| topic | Bioelectronics Neurological disorder Neuromodulation Peripheral nerve stimulation Opioids Rrestless legs syndrome |
| url | https://doi.org/10.1186/s12883-023-03462-6 |
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