TOMAC for Restless Legs: Four RESTFUL Trial Checks

Tonic motor activation, or TOMAC, uses electrical stimulation through skin electrodes to activate leg muscles via the peroneal nerves. The FDA’s NTX100 decision describes a prescription treatment for adults with primary moderate-to-severe restless legs syndrome whose symptoms are refractory to medication.¹

1. Did the participants resemble you?

RESTFUL enrolled 133 adults, including 80 women, at seven US sleep clinics. They had moderate-to-severe primary restless legs despite previous medication treatment. 68 received active treatment and 65 received sham for four weeks; existing RLS medicines were intended to remain stable.²

This was not a trial of stopping medication and replacing it with a device. Ask the prescriber what “refractory” means in your case and which medicine, iron or sleep-apnea issues still need review. The AASM guideline advises checking iron studies and addressing factors that can worsen RLS, including certain medicines and untreated obstructive sleep apnea.³

2. What counted as a response?

At four weeks, 45% with active treatment versus 16% with sham met the primary response definition: a clinician rated them “much improved” or “very much improved.” Response did not mean symptom elimination. Mean symptom-score reductions were 7.2 versus 3.8 points, a 3.4-point difference favoring active treatment.²

Before treatment, agree which change you want to track: fewer evenings interrupted by the urge to move, easier sleep onset, or another symptom you can describe. Ask how the clinic will judge whether the benefit justifies continued use.

3. Which results had a sham comparison?

In weeks five through eight, everyone received active treatment openly. Response reached 61% in the group originally assigned active treatment, but this later result had no continuing sham comparison. Noctrix Health⁴ funded the trial; an author was its employee with patent and stock interests.²

The 2025 AASM guideline gives bilateral high-frequency peroneal nerve stimulation a conditional recommendation, with moderate certainty of evidence. Its assessment found a small effect on disease severity across two randomized trials and noted risk of bias and high treatment cost.³

Ask for the total cost, including replacement supplies, and which trial period or return terms apply to the device being offered. Get the review date and payment terms before ordering; a recommendation in a guideline does not tell you your insurance benefit.

4. Which model and safety instructions apply?

In the first four weeks, discomfort affected 28% with active treatment versus 8% with sham. No serious or severe device-related adverse events were reported.²

RESTFUL’s device was the NTX100.¹² The current manufacturer manual linked below is for the NTX150.⁴ Ask which model you are being prescribed and have the team review its instructions with you.

The NTX150 manual lists contraindications including seizure disorders, active implanted medical devices, metal at the leg treatment site other than knee replacements, relevant material allergies, and cellulitis, open sores or injury near application. Pregnancy safety has not been established. It prohibits use while driving or operating machinery.⁴

Discomfort, skin irritation and interference with preferred sleep positions can occur. The manual says to stop use and consult a physician for adverse reactions.⁴ These are selected points for the appointment, not the complete safety instructions or directions for placing electrodes.

Chapter 8 of Did I Do That in My Sleep? includes “The Legs That Won’t Settle.” Its suggested description separates an urge while awake from kicks someone sees during sleep. Bring that description, your medicine list and the treatment changes you have already tried to the device discussion.