PMID- 37458698
OWN - NLM
STAT- MEDLINE
DCOM- 20231012
LR  - 20231013
IS  - 1550-9109 (Electronic)
IS  - 0161-8105 (Print)
IS  - 0161-8105 (Linking)
VI  - 46
IP  - 10
DP  - 2023 Oct 11
TI  - Efficacy and safety of tonic motor activation (TOMAC) for medication-refractory 
      restless legs syndrome: a randomized clinical trial.
LID - 10.1093/sleep/zsad190 [doi]
LID - zsad190
AB  - STUDY OBJECTIVES: The purpose of this study was to evaluate the efficacy and 
      safety/tolerability of bilateral high-frequency tonic motor activation (TOMAC) in 
      patients with medication-refractory restless legs syndrome (RLS). METHODS: 
      RESTFUL was a multicenter, randomized, double-blind, sham-controlled trial in 
      adults with medication-refractory moderate-to-severe primary RLS. Participants 
      were randomized 1:1 to active or sham TOMAC for a double-blind, 4-week stage 1 
      and all received active TOMAC during open-label, 4-week stage 2. The primary 
      endpoint was the Clinical Global Impressions-Improvement (CGI-I) responder rate 
      at the end of stage 1. Key secondary endpoints included change to International 
      RLS Study Group (IRLS) total score from study entry to the end of stage 1. 
      RESULTS: A total of 133 participants were enrolled. CGI-I responder rate at the 
      end of stage 1 was significantly greater for the active versus sham group (45% 
      vs. 16%; Difference = 28%; 95% CI 14% to 43%; p = .00011). At the end of stage 2, 
      CGI-I responder rate further increased to 61% for the active group. IRLS change 
      at the end of stage 1 improved for the active versus sham group (-7.2 vs. -3.8; 
      difference = -3.4; 95% CI -1.4 to -5.4; p = .00093). There were no severe or 
      serious device-related adverse events (AEs). The most common AEs were mild 
      discomfort and mild administration site irritation which resolved rapidly and 
      reduced in prevalence over time. CONCLUSIONS: TOMAC was safe, well tolerated, and 
      reduced symptoms of RLS in medication-refractory patients. TOMAC is a promising 
      new treatment for this population. CLINICAL TRIAL: Noninvasive Peripheral Nerve 
      Stimulation for Medication-Refractory Primary RLS (The RESTFUL Study); 
      clinicaltrials.gov/ct2/show/NCT04874155; Registered at ClinicalTrials.gov with 
      the identifier number NCT04874155.
CI  - (c) The Author(s) 2023. Published by Oxford University Press on behalf of Sleep 
      Research Society.
FAU - Bogan, Richard K
AU  - Bogan RK
AUID- ORCID: 0000-0001-7043-2974
AD  - Bogan Sleep Consultants, LLC, Columbia, SC, USA.
FAU - Roy, Asim
AU  - Roy A
AD  - Ohio Sleep Medicine Institute, Dublin, OH, USA.
FAU - Kram, Jerrold
AU  - Kram J
AD  - California Center for Sleep Disorders, San Leandro, CA, USA.
FAU - Ojile, Joseph
AU  - Ojile J
AD  - Clayton Sleep Institute, LLC, St. Louis, MO, USA.
FAU - Rosenberg, Russell
AU  - Rosenberg R
AD  - NeuroTrials Research Inc., Atlanta, GA, USA.
FAU - Hudson, J Douglas
AU  - Hudson JD
AD  - FutureSearch Trials of Neurology, Austin, TX, USA.
FAU - Scheuller, H Samuel
AU  - Scheuller HS
AD  - Delta Waves, Inc., Colorado Springs, CO, USA.
FAU - Winkelman, John W
AU  - Winkelman JW
AD  - Massachusetts General Hospital, Boston, MA, USA.
FAU - Charlesworth, Jonathan D
AU  - Charlesworth JD
AUID- ORCID: 0000-0002-6651-0009
AD  - Noctrix Health, Inc., Pleasanton, CA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT04874155
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Sleep
JT  - Sleep
JID - 7809084
RN  - 0 (Dopamine Agonists)
SB  - IM
CIN - Sleep. 2023 Sep 06;:. PMID: 37671678
MH  - Adult
MH  - Humans
MH  - Treatment Outcome
MH  - *Restless Legs Syndrome/drug therapy/diagnosis
MH  - Severity of Illness Index
MH  - Double-Blind Method
MH  - Dopamine Agonists/adverse effects
PMC - PMC10566236
OTO - NOTNLM
OT  - bioelectronic
OT  - neurological disorder
OT  - neuromodulation
OT  - peripheral nerve stimulation
OT  - restless legs syndrome
OT  - sleep disorder
EDAT- 2023/07/17 15:09
MHDA- 2023/10/12 06:43
PMCR- 2023/07/17
CRDT- 2023/07/17 10:33
PHST- 2023/06/14 00:00 [received]
PHST- 2023/07/07 00:00 [revised]
PHST- 2023/10/12 06:43 [medline]
PHST- 2023/07/17 15:09 [pubmed]
PHST- 2023/07/17 10:33 [entrez]
PHST- 2023/07/17 00:00 [pmc-release]
AID - 7225271 [pii]
AID - zsad190 [pii]
AID - 10.1093/sleep/zsad190 [doi]
PST - ppublish
SO  - Sleep. 2023 Oct 11;46(10):zsad190. doi: 10.1093/sleep/zsad190.