0712 Tonic Motor Activation for Restless Legs Syndrome Is Compatible with Sleep Onset and Reduces Periodic Leg Movements
Stephanie Rigot, Bahman Adlou, Viktoriia Kolotovska, Jatin Tekchandani, Jonathan CharlesworthAbstract
Introduction
Tonic motor activation (TOMAC) is a noninvasive neurostimulation therapy indicated for refractory restless legs syndrome (RLS). Here, we characterized the acute response to TOMAC based on objective evidence from polysomnography (PSG).
Methods
Adults with primary moderate-severe refractory RLS (n=23) were enrolled in a clinical trial (NCT05214963) that included a night of PSG with TOMAC treatment. Participants were instructed to activate TOMAC sessions to address RLS symptoms before sleep onset (bedtime session, n=8) and/or awakenings during the sleep period (mid-sleep session, n=19). When activated, TOMAC bilaterally stimulated the peroneal nerve for 30-minutes and turned off automatically. For each 30-minute TOMAC session, periodic leg movements during sleep (PLMS) were compared between the last 15min of sleep before TOMAC activation and the first 15min of sleep after TOMAC activation.
Results
Sleep initiation occurred during 75% of bedtime TOMAC sessions and 84% of mid-sleep TOMAC sessions. Mean duration from TOMAC activation to sleep was 21.9 min for bedtime sessions (median 16.1, SD 15.7) and 13.6 minutes for mid-sleep sessions (median 7.4, SD 15.4). Mean TOMAC intensity at the time of sleep onset/re-initiation was 27.2mA (SD: 5.8), similar to previous clinical trials. For mid-sleep TOMAC sessions, mean PLMS frequency reduced by 75% from 36.7/hour (SD: 68.6) before TOMAC activation to 9.1/hour (SD: 37.5, p< 0.01) after TOMAC activation; this corresponded to 68% reduction relative to mean PLMS frequency during the full sleep period (28.6/hour).
Conclusion
TOMAC was compatible with sleep; both sleep onset and re-initiation were prevalent during TOMAC administration at therapeutic stimulation intensities. TOMAC was also associated with significant acute reduction in PLMS. These results motivate investigation of the longer-term effects of TOMAC on sleep architecture and PLMS.
Support (if any)
Sponsored by Noctrix Health and supported by NIH/NINDS R44NS117294.