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Studies

Interventional Not yet recruiting

NCT07397247 on ClinicalTrials.gov

Tonic Motor Activation (TOMAC) Therapy in Patients With Restless Legs Syndrome and Dopaminergic Augmentation

Official title: Evaluating Response to Tonic Motor Activation (TOMAC) Therapy for Patients With Restless Legs Syndrome and Dopaminergic Augmentation

  • Sponsor: Noctrix Health, Inc.
  • Enrollment: 50 (Estimated)
  • Study start: 2026-04-01 (Estimated)
  • Primary completion: 2027-01-01 (Estimated)
  • Study completion: 2027-01-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • InterventionModelDescription: This is a single-arm, open-label interventional study in which all enrolled participants receive Tonic Motor Activation (TOMAC) therapy and are followed over a defined treatment period to assess response.
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

This study evaluates Tonic Motor Activation (TOMAC) therapy in adults with restless legs syndrome and dopaminergic augmentation. Participants use a noninvasive peroneal nerve stimulation device over a defined treatment period to assess symptom response and medication use.

Conditions

  • Restless Legs Syndrome

Intervention / Treatment

  • Device: Tonic Motor Activation (TOMAC) Device

Primary Outcome Measures

  • Change in IRLS total score at Week 8 relative to Baseline (study entry) (8 Weeks)
    The International Restless Legs Syndrome Study Group (IRLS) Rating Scale is a participant-reported questionnaire assessing the severity of restless legs syndrome symptoms, with total scores ranging from 0 to 40, where higher scores indicate greater severity. The outcome is the change in IRLS total score from baseline (study entry) to Week 8.

Countries

Austria

Locations and Investigators

  • Medical University of Innsbruck, Innsbruck, Austria