Open-label MNS for Tourette Syndrome

Number of minutes per day the device was used, only counting days in which the device was turned on, over the four-week period after the initial visit

Number of days per week the device was used

Answered yes (from options yes / no / maybe) to the question, "Do you expect to continue to use the stimulator?"

Change in self-reported tic frequency on the frequency item (score range from 0 = no tics [better] to 5 = always [worse]) from the Yale Global Tic Severity Scale (YGTSS) from the beginning to the end of each stimulation period. Participants were instructed to answer this question every time they turned on the device and every time they turned it off, every day for 4 weeks. The difference between the turning off score and the previous turning on score was averaged across all ratings completed during the 4 weeks of the trial. The wording of the score anchors is provided at https://osf.io/7pjk4 .

Change in self-reported tic intensity on the intensity item (score range from 0 = no tics [better] to 5 = severe intensity [worse]) from the Yale Global Tic Severity Scale (YGTSS) from the beginning to the end of each stimulation period. Participants were instructed to answer this question every time they turned on the device and every time they turned it off, every day for 4 weeks. The difference between the turning off score and the previous turning on score was averaged across all ratings completed during the 4 weeks of the trial.

Mean discomfort while using the stimulator, on a 0-3 scale adapted from the Clinical Global Impression - Improvement [CGI-I] Efficacy Index. Specifically, the prompt was "How much DISCOMFORT did the stimulation cause?", and the participant selected one of the following responses:

0 = NO discomfort

• = discomfort noticeable, but not severe enough to concern me or to turn it off
• = enough discomfort, impairment of functioning or social embarrassment that I would only keep it on if the benefit was considerable
• = caused discomfort, impairment of functioning or social embarrassment to a degree that any treatment benefit was not worth leaving it on Higher values represent a worse outcome. Discomfort was reported at the end of each stimulation period, and at random times twice daily between 9a.m. and 9p.m. when prompted by text message, if the device was on when the text was received.

Overall impact of the stimulation on symptoms throughout the study period:

• = Very much improved - nearly all better; good level of functioning; minimal symptoms; represents a very substantial change
• = Much improved - notably better with significant reduction of symptoms; increase in the level of functioning but some symptoms remain
• = Minimally improved - slightly better with little or no clinically meaningful reduction of symptoms. Represents very little change in basic clinical status, level of care, or functional capacity
• = No change - symptoms remain essentially unchanged
• = Minimally worse - slightly worse but may not be clinically meaningful; may represent very little change in basic clinical status, level of care, or functional capacity
• = Much worse - clinically significant increase in symptoms and diminished functioning
• = Very much worse - severe exacerbation of symptoms and loss of functioning On this scale, lower numbers indicate a better outcome.

Overall discomfort from stimulation throughout the study period. The prompt for this survey question was: "On average, over the course of the study, how much DISCOMFORT did the stimulation cause? (If discomfort is the wrong word, please substitute any negative effects or side effects of stimulation.)" Participants chose one of the following answers:

0 no discomfort

• discomfort noticeable, but not severe enough to concern me or to turn it off
• enough discomfort, impairment of functioning or social embarrassment that I would only keep it on if the benefit was considerable
• caused discomfort, impairment of functioning or social embarrassment to a degree that any treatment benefit was not worth leaving it on On this scale, lower numbers represent a better outcome.

Mean self-rated therapeutic effect (from the modified CGI Efficacy Index) when device is on, reported at the end of the study. Specifically, the prompt for this question was "On average, over the course of the study, how much did your tics IMPROVE during stimulation?" Participants chose one of the following answers:

0 Unchanged or worse

• Minimal - Slight improvement that doesn't decrease the overall impact of symptoms.
• Moderate - Decided improvement. Partial remission of symptoms
• Marked - Vast improvement. Complete or nearly complete remission of all symptoms On this scale, higher numbers represent a better outcome.

Self-rated tic severity over the past week using the Adult Tic Questionnaire (ATQ), first rating at (or within 2 weeks prior to) the beginning of study participation and second rating at the end of study participation. Higher ATQ scores reflect a worse outcome. For each tic present in the past week, its severity score is the sum of its frequency score (0-4, 4 worst, occurring "almost all the time during the day") and its intensity score (0-4, 4 worst). The ATQ severity score is the sum of the severity score for each of up to 27 tics present in the past week. The minimum possible severity score on the ATQ is 0, indicating that no tics were present in the past week. The maximum possible severity score on the ATQ indicates is 216, indicating that a tic of each of the 27 types listed was present in the past week, each with an item severity score of 8 = 4 + 4.

On the survey at the end of study participation, the relevant question asked: "On average, over the course of the study, how long do you think the improvement in your tics lasted after you turned off the device? Give answer in minutes. Enter 0 (zero) if improvement with stimulation stopped immediately when you turned the device off." On this item, higher answers indicate a better outcome.