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Optimizing Extended-Duration (XD-) TOMAC Therapy for Restless Legs Syndrome (RLS)

NCT07675109 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-06-30

No results posted yet for this study

Summary

This study assesses the tolerability, safety, and impact of an investigational medical device on restless legs syndrome symptoms.

The IRB has established that the investigational device is non-significant risk.

Conditions

  • Restless Legs Syndrome (RLS)

Interventions

DEVICE

Investigational Extended Duration (XD-) TOMAC Therapy

The investigational noninvasive neuromodulation device will be setup by the participant at bedtime and used to provide Extended Duration Tonic Motor Activation (XD-TOMAC) every night. The IRB has established that the investigational device is non-significant risk.

DEVICE

Tonic Motor Activation (TOMAC) Therapy

The noninvasive neuromodulation device will be setup by the participant to be used for TOMAC 30-minute stimulation therapy sessions as needed during the 2nd week of the study and as appropriate for the remainder of the study. The IRB has established that the device is non-significant risk.

Sponsors & Collaborators

  • Noctrix Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Jonathan D Charlesworth, PhD · Noctrix Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-08
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07675109 on ClinicalTrials.gov