Restless Legs Syndrome (RLS)NCT07675109
Optimizing Extended-Duration (XD-) TOMAC Therapy for Restless Legs Syndrome (RLS)
A study testing Investigational Extended Duration (XD-) TOMAC Therapy and Tonic Motor Activation (TOMAC) Therapy in people with Restless Legs Syndrome (RLS), run by Noctrix Health, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Restless Legs Syndrome (RLS)
- What is being tested?
- Investigational Extended Duration (XD-) TOMAC Therapy and Tonic Motor Activation (TOMAC) Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
- Subject has a primary sleep disorder other than RLS that significantly interferes with sleep at the present time (e.g. obstructive sleep apnea stably controlled via CPAP would not be an exclusion).
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Noctrix Health Headquarters
Pleasanton, California, 94566
Clinical Research Coordinator, 415-531-1578, clinicalcoordinator@noctrixhealth.com
Jonathan D Charlesworth, PhD
About this study
Official title: Form, Fit and Function Feasibility Study
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.
Read the detailed description
In this 12-week study, participants complete a 1-week baseline (no intervention) followed by 1-week Tonic Motor Activation (TOMAC) therapy (30-minutes of stimulation). Next, participants complete 4-weeks of Extended Duration (XD-) TOMAC. Then, participants will complete investigational TOMAC medical device interventions for 6-weeks in a pseudo-randomized order.
- Conditions
- Restless Legs Syndrome (RLS)
- Being tested
- Investigational Extended Duration (XD-) TOMAC Therapy, Tonic Motor Activation (TOMAC) Therapy
- Keywords
- TOMAC, stimulation, neuromodulation, RLS
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Extended Duration (XD-) TOMAC TherapyDevice
Also called Noninvasive Neuromodulation, XD-TOMAC
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.
Tonic Motor Activation (TOMAC) TherapyDevice
Also called Noninvasive Neuromodulation, TOMAC
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Investigational Extended Duration (XD-) TOMAC Therapy; Device: Tonic Motor Activation (TOMAC) Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (6)
Mean change in International RLS Study Group Rating Scale (IRLS) total score
International Restless Legs Syndrome Study Group (IRLS) Rating Scale Score is a participant-rated questionnaire that rates RLS severity from 0-40, where 40 is the most severe. The mean change is assessed over the final week of each intervention and compared to assessment at Study Entry.
Measured: 12 weeks
Mean change in sleep efficiency percentage
Sleep efficiency (SE) is the percentage of the time a person spends asleep relative to the total time dedicated to sleep. A better outcome corresponds to a percentage closer to 100%. Assessed via daily sleep diary and compared from the last week of each intervention to the Baseline period.
Measured: 12 weeks
Mean change in minutes awake after sleep onset (WASO)
Minutes Awake after Sleep Onset (WASO) refer to the total number of minutes awake after first going to sleep and before waking up for the next day in the morning. Lower WASO corresponds to a better outcome. Assessed via daily sleep diary and compared from the last week of each intervention to the Baseline period.
Measured: 12 weeks
Mean change in minutes awake after sleep onset with RLS symptoms (WASO-R)
Minutes Awake after Sleep Onset (WASO-R) refer to the total number of minutes awake with RLS symptoms after first going to sleep and before waking up for the next day in the morning. Lower WASO-R corresponds to a better outcome. Assessed via daily sleep diary and compared from the last week of each intervention to the Baseline period.
Measured: 12 weeks
Mean change in Medical Outcomes Study Sleep Problems Index II (MOS-II) score
The Medical Outcomes Study Sleep Problems Index II (MOS-II) score is a subscale of the participant-rated MOS questionnaire that measures subjective sleep quality. The MOS-I (6-items) and MOS-II (9-items) are the two validated subscales of the 12-item MOS Sleep Scale. Both are scored from 0 to 100, where 100 corresponds to the worst possible sleep problems and 0 corresponds to no sleep problems. The mean change is assessed over the final 2-weeks of each intervention and compared to assessment at Study Entry.
Measured: 12 weeks
Patient Global Impressions - Improvement (PGI-I) responder rate
The Responder Rate is the percentage of subjects with a Patient Global Impressions of Improvement (PGI-I) rating of Much Improved or Very Much Improved relative to study entry. The scores for the Patient Global Impressions of Improvement (PGI-I) are: Very Much Improved (1), Much Improved (2), Minimally Improved (3), No Change (4), Minimally Worse (5), Much Worse (6), Very Much Worse (7). Assessed over the final week of each intervention.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start8 Jun 2026
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs Syndrome (RLS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will receive each of three interventions in the final phase of the study in a pseudo-randomized order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noctrix Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan D Charlesworth, PhD, Principal investigator, Noctrix Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675109
- Sponsor's protocol ID
- CT-12 Sub-study 12
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Due to the investigational nature of the device, IPD will not be shared for this study.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Form, Fit and Function Feasibility Study
- ClinicalTrials.gov ID
- NCT07675109
- Acronym / sponsor ID
- CT-12 Sub-study 12
- Conditions
- Restless Legs Syndrome (RLS)
- Keywords
- TOMAC, stimulation, neuromodulation, RLS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Noctrix Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this 12-week study, participants complete a 1-week baseline (no intervention) followed by 1-week Tonic Motor Activation (TOMAC) therapy (30-minutes of stimulation). Next, participants complete 4-weeks of Extended Duration (XD-) TOMAC. Then, participants will complete investigational TOMAC medical device interventions for 6-weeks in a pseudo-randomized order.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants will receive each of three interventions in the final phase of the study in a pseudo-randomized order.
| Arm | Type | Receives |
|---|---|---|
| Investigational XD-TOMAC Therapy 1 | Experimental | Device: Investigational Extended Duration (XD-) TOMAC Therapy, Device: Tonic Motor Activation (TOMAC) TherapyParticipants 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. |
| Investigational XD-TOMAC Therapy 2 | Experimental | Device: Investigational Extended Duration (XD-) TOMAC Therapy, Device: Tonic Motor Activation (TOMAC) TherapyParticipants 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. |
| Investigational XD-TOMAC Therapy 3 | Experimental | Device: Investigational Extended Duration (XD-) TOMAC Therapy, Device: Tonic Motor Activation (TOMAC) TherapyParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Extended Duration (XD-) TOMAC TherapyAlso: Noninvasive Neuromodulation, XD-TOMACThe 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 | Investigational XD-TOMAC Therapy 1, Investigational XD-TOMAC Therapy 2, Investigational XD-TOMAC Therapy 3 |
| Tonic Motor Activation (TOMAC) TherapyAlso: Noninvasive Neuromodulation, TOMACThe 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. | Device | Investigational XD-TOMAC Therapy 1, Investigational XD-TOMAC Therapy 2, Investigational XD-TOMAC Therapy 3 |
Primary outcome
Number of RLS-related awakenings per night
Time frame: 12 weeks
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
6 secondary outcomes
Mean change in International RLS Study Group Rating Scale (IRLS) total score
Time frame: 12 weeks
Mean change in sleep efficiency percentage
Time frame: 12 weeks
Mean change in minutes awake after sleep onset (WASO)
Time frame: 12 weeks
Mean change in minutes awake after sleep onset with RLS symptoms (WASO-R)
Time frame: 12 weeks
Mean change in Medical Outcomes Study Sleep Problems Index II (MOS-II) score
Time frame: 12 weeks
Patient Global Impressions - Improvement (PGI-I) responder rate
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No. Due to the investigational nature of the device, IPD will not be shared for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan D Charlesworth, PhD principal investigator
Noctrix Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Extended Duration (XD-) TOMAC Therapy and Tonic Motor Activation (TOMAC) Therapy in people with Restless Legs Syndrome (RLS), run by Noctrix Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Coordinator (415-531-1578, clinicalcoordinator@noctrixhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of RLS-related awakenings per night (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.