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

NCT07675109 | Recruiting FDA Device

• 1 other identifier: CT-12 Sub-study 12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

TOMAC; stimulation; neuromodulation; RLS

Outcome Measures

Primary Outcomes (1)

• Number of RLS-related awakenings per night

  This outcome measures the number of awakenings per night that were related to RLS symptoms. A lower number represents a better outcome. Assessed via daily sleep diary and compared for each intervention to the Baseline period

  12 weeks

Secondary Outcomes (6)

• Mean change in International RLS Study Group Rating Scale (IRLS) total score

  12 weeks

• Mean change in sleep efficiency percentage

  12 weeks

• Mean change in minutes awake after sleep onset (WASO)

  12 weeks

• Mean change in minutes awake after sleep onset with RLS symptoms (WASO-R)

  12 weeks

• Mean change in Medical Outcomes Study Sleep Problems Index II (MOS-II) score

  12 weeks

Study Arms (3)

Investigational XD-TOMAC Therapy 1

EXPERIMENTAL

Participants will use investigational noninvasive neuromodulation device for XD-TOMAC therapy as instructed for 3, 2-week periods over the final 6-weeks of the study. The XD-TOMAC therapy settings may change for each of the 2-week periods in a pseudo-randomized order. Investigational XD-TOMAC settings may include different methods for modulating the stimulation waveform.

Device: Investigational Extended Duration (XD-) TOMAC Therapy; Device: Tonic Motor Activation (TOMAC) Therapy

Investigational XD-TOMAC Therapy 2

EXPERIMENTAL

Participants will use investigational noninvasive neuromodulation device for XD-TOMAC therapy as instructed for 3, 2-week periods over the final 6-weeks of the study. The XD-TOMAC therapy settings may change for each of the 2-week periods in a pseudo-randomized order. Investigational XD-TOMAC settings may include different methods for modulating the stimulation waveform.

Device: Investigational Extended Duration (XD-) TOMAC Therapy; Device: Tonic Motor Activation (TOMAC) Therapy

Investigational XD-TOMAC Therapy 3

EXPERIMENTAL

Participants will use investigational noninvasive neuromodulation device for XD-TOMAC therapy as instructed for 3, 2-week periods over the final 6-weeks of the study. The XD-TOMAC therapy settings may change for each of the 2-week periods in a pseudo-randomized order. Investigational XD-TOMAC settings may include different methods for modulating the stimulation waveform.

Device: Investigational Extended Duration (XD-) TOMAC Therapy; Device: Tonic Motor Activation (TOMAC) Therapy

Interventions

Investigational Extended Duration (XD-) TOMAC Therapy DEVICE

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.

Also known as: Noninvasive Neuromodulation, XD-TOMAC

Investigational XD-TOMAC Therapy 1; Investigational XD-TOMAC Therapy 2; Investigational XD-TOMAC Therapy 3

Tonic Motor Activation (TOMAC) Therapy DEVICE

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.

Also known as: Noninvasive Neuromodulation, TOMAC

Investigational XD-TOMAC Therapy 1; Investigational XD-TOMAC Therapy 2; Investigational XD-TOMAC Therapy 3

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has signed a valid, IRB-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English
• Subject has received a medical diagnosis of primary restless legs syndrome (RLS).
• Subject agrees to not change dosage or schedule of any medications that are known to impact RLS symptoms during the study, including RLS medications, antidepressants, sleep medications, or sedative antihistamines or treatments such as CPAP (continuous positive airway pressure).
• Subject reports that RLS symptoms are most significant in lower legs and/or feet.
• Subject reports that RLS symptoms caused awakenings or interfered with falling back asleep at least 3 nights per week during the month prior to study entry.
• The subject possesses the necessary equipment, internet/phone accessibility, and communication ability to complete electronic questionnaires and respond to electronic communications and phone calls from the research staff throughout the in-home portion of the study.
• Subject has moderate-severe RLS symptoms as defined by a score of 15 or greater points on IRLS (International Restless Legs Syndrome Study Group Rating Scale).
• Subject is 21 years of age or older.

You may not qualify if:

• The subject has an active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators).
• The subject has a metal implant at the site of the study device electrode application (not including knee replacements).
• The subject has been diagnosed with epilepsy or other seizure disorder.
• The subject has a moderate or severe cognitive disorder or mental illness that would affect his or her ability to participate in the study.
• The subject has a known allergy to device materials, electrode gel, polyurethane foam, or lycra (or a severe previous reaction to medical adhesives or bandages).
• Subject has any of the following at or near the location of device application: Acute injury, Cellulitis, Open sores
• The subject is unable or unwilling to comply with study requirements.
• The subject has a medical condition not listed above that may put them at risk.
• Subject has prior experience with neurostimulation devices developed by the study sponsor
• On nights with no RLS symptoms (if any), subject reports typical sleep onset latency of \>60min.
• Subject has severe peripheral neuropathy affecting the lower legs and/or subject has neuropathy and is unable to clearly distinguish between symptoms of neuropathy and symptoms of RLS.
• Subject reports a habitual sleep schedule that is not primarily aligned with nighttime hours (bedtime 8:00pm-2:00am and morning awakening 4:00am-11:00am), or reports that bedtime regularly varies by more than 4 hours (e.g., due to shift work or an inconsistent sleep schedule).
• Subject is taking an unstable or inconsistent dose or schedule of medication that is likely to impact RLS symptoms or sleep, such as RLS medications, antidepressants, sleep medications, or sedative antihistamines.
• Subject has changed dose or schedule of medication or treatment that is likely to impact RLS symptoms or sleep in the past 30 days, such as RLS medications, antidepressants, sleep medications, or sedative antihistamines or treatments such as CPAP.
• During initial device set-up, device does not properly fit the subject or calibrated intensity settings are outside of operational range

Sponsors & Collaborators

• Noctrix Health, Inc.: lead

Study Sites (1)

Noctrix Health Headquarters

Pleasanton, California, 94566, United States

RECRUITING

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• Jonathan D Charlesworth, PhD

  Noctrix Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Coordinator

CONTACT

415-531-1578; clinicalcoordinator@noctrixhealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will receive each of three interventions in the final phase of the study in a pseudo-randomized order.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)