NCT07397247

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Noctrix Health, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study includes a 24-week period during which participants use Tonic Motor Activation (TOMAC) therapy delivered by a noninvasive peroneal nerve stimulation device with investigational settings, including the option for extended-duration stimulation. Participants are prospectively assigned to receive TOMAC therapy according to a predefined, multi-stage study protocol. The study consists of two phases: an initial 8-week period of stable medication use with device therapy, followed by a 16-week period during which dopamine agonist medication tapering may occur while device therapy continues, as clinically appropriate. While statistical power calculations indicate that approximately 15 evaluable participants are sufficient for the primary endpoint, up to 50 participants may be enrolled to improve estimate precision and account for attrition.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DEVICE	Tonic Motor Activation (TOMAC) Device	Tonic Motor Activation (TOMAC) therapy is delivered using a noninvasive peroneal nerve stimulation device. Participants use the device according to the study protocol over a defined treatment period. The device is used by participants in the home setting according to study instructions.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: Austria

Regulatory

• FDA-regulated device study