CompletedNot Applicable

Open-label MNS for Tourette Syndrome

United States31 participantsStarted 2021-11-18

Plain-language summary

A recent report (Morera Maiquez et al 2020) described reduced tic severity in people with Tourette syndrome during 1-minute epochs of median nerve stimulation (MNS) at 10 Hz. Among the various questions still to be answered is the question of whether a device to administer MNS is practical for use in a chronic, real-world setting. This study will recruit participants who complete the clinic-based, blinded, randomized controlled trial, https://clinicaltrials.gov/ct2/show/NCT04731714, to determine the real-world usage and apparent utility of median nerve stimulation in people with chronic tics.

Who can participate

Age range

15 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Completed participation in the study called "Peripheral induction of inhibitory brain circuits to treat Tourette's: pilot" * Informed consent by adult participant, or assent by child and informed consent by guardian Exclusion Criteria: * Has an implanted device that could be affected by electrical current * Pregnancy known to participant or (for children) to the parent * Severe or unstable systemic illness * Factors (such as exaggerated symptom report) that in the judgment of the principal investigator may make the outcome measures inaccurate * Judged by investigator to be unlikely to complete study procedures

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time Spent Using the Device Per Day of Use

Timeframe: At study conclusion, up to 4 weeks

Time Spent Using the Device (Days Per Week)

Timeframe: At study conclusion, up to 4 weeks

Plan to Continue MNS (Median Nerve Stimulation)

Timeframe: At study conclusion, up to 1 month

Change in Tic Frequency With Stimulation

Timeframe: Recorded every time the device was turned on and every time it was turned off, up to 4 weeks

Change in Tic Intensity With Stimulation

Timeframe: Recorded every time the device was turned on and every time it was turned off, up to 4 weeks

Discomfort

Timeframe: Recorded every time the device was turned off, and every time the participant was prompted by a text to fill out the survey if the device was on when the text was received, up to 4 weeks.

Trial details

NCT IDNCT05016765

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-27

Results submitted2023-04-26

View on ClinicalTrials.gov More Tourette Syndrome trials

Plain-language summary

Who can participate

Age range

15 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Time Spent Using the Device Per Day of Use

Timeframe: At study conclusion, up to 4 weeks

Time Spent Using the Device (Days Per Week)

Timeframe: At study conclusion, up to 4 weeks

Plan to Continue MNS (Median Nerve Stimulation)

Timeframe: At study conclusion, up to 1 month

Change in Tic Frequency With Stimulation

Timeframe: Recorded every time the device was turned on and every time it was turned off, up to 4 weeks

Change in Tic Intensity With Stimulation

Timeframe: Recorded every time the device was turned on and every time it was turned off, up to 4 weeks

Discomfort

Timeframe: Recorded every time the device was turned off, and every time the participant was prompted by a text to fill out the survey if the device was on when the text was received, up to 4 weeks.