NCT05016765

Open-label MNS for Tourette Syndrome

Completed NA Results posted Last updated 5 October 2023

What this trial tests

NA trial testing Active, self-directed electrical stimulation of the median nerve in Tourette Syndrome in 31 participants. Completed in 27 April 2022.

Timeline

18 November 2021

Primary endpoint
27 April 2022

27 April 2022

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	18 November 2021
Primary completion	27 April 2022
Estimated completion	27 April 2022
Sites	1 location across United States

Drugs / interventions tested

• Active, self-directed electrical stimulation of the median nerve

Conditions studied

• Tourette Syndrome — all drugs for Tourette Syndrome →
• Tic Disorder, Chronic Motor or Vocal — all drugs for Tic Disorder, Chronic Motor or Vocal →

Sponsor

Washington University School of Medicine

Who can join

Adults 15 to 65, any sex, with Tourette Syndrome or Tic Disorder, Chronic Motor or Vocal. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time Spent Using the Device Per Day of Use Primary · At study conclusion, up to 4 weeks

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

Group	Value	95% CI
Active MNS	49.6	24.2 – 117.2

Time Spent Using the Device (Days Per Week) Primary · At study conclusion, up to 4 weeks

Number of days per week the device was used

Group	Value	95% CI
Active MNS	1.5	0.6 – 2.0

Plan to Continue MNS (Median Nerve Stimulation) Primary · At study conclusion, up to 1 month

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

Group	Value	95% CI
Active MNS	21

Change in Tic Frequency With Stimulation Primary · Recorded every time the device was turned on and every time it was turned off, up to 4 weeks

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/7pj

All participants "turning ON" surveys

Group	Value	95% CI
Active MNS	3.1	± 1.0

All participants "turning OFF" surveys

Group	Value	95% CI
Active MNS	2.1	± 1.1

Change in Tic Intensity With Stimulation Primary · Recorded every time the device was turned on and every time it was turned off, up to 4 weeks

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.

All participants "turning ON" surveys

Group	Value	95% CI
Active MNS	2.9	± 0.8

All participants "turning OFF" surveys

Group	Value	95% CI
Active MNS	2.0	± 1.1

Discomfort Primary · 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.

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 1. = discomfort noticeable, but not severe enough to concern me or to turn it off 2. = enough discomfort, impairment of functioning or social embarrassment that I would only keep it on if the benefit was considerable 3. = caused discomfort, impairment of functioning or social embarrassment to a d

Group	Value	95% CI
Active MNS	1.0	0.6 – 1.5

CGI-I (Clinical Global Impression--Improvement) Secondary · At study conclusion, up to 4 weeks

Overall impact of the stimulation on symptoms throughout the study period: 1. = Very much improved - nearly all better; good level of functioning; minimal symptoms; represents a very substantial change 2. = Much improved - notably better with significant reduction of symptoms; increase in the level of functioning but some symptoms remain 3. = 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 4. = No change - symptoms remain essentially unchanged 5. =

Group	Value	95% CI
Active MNS	3.1	2.7 – 3.4

CGI Efficacy Index: Side Effects Secondary · At study conclusion, up to 4 weeks

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 1. discomfort noticeable, but not severe enough to concern me or to turn it off 2. enough discomfort, impairment of functioning or social embarrassment that I would only keep it on if the benefit was considerable 3. caused discomf

Group	Value	95% CI
Active MNS	1.2	± 1.0

Mean Therapeutic Effect During Stimulator Use Secondary · At study conclusion, up to 4 weeks

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 1. Minimal - Slight improvement that doesn't decrease the overall impact of symptoms. 2. Moderate - Decided improvement. Partial remission of symptoms 3. Marked - Vast improvement. Complete or nearly complete remission of all symptoms On this scale, higher nu

Group	Value	95% CI
Active MNS	1.5	1.1 – 1.9

Change in Self-reported Tic Severity Secondary · At beginning of study participation or up to 2 weeks prior, and again at end of study participation up to 4 weeks

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

baseline score

Group	Value	95% CI
Active MNS	35.4	± 16.7

final survey score

Group	Value	95% CI
Active MNS	34.6	± 22.5

Self-reported Duration of MNS Benefit, in Minutes Secondary · Monitored over the entire period of study participation, up to 4 weeks

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.

Group	Value	95% CI
Active MNS	15	10 – 45

Adverse events — posted to ClinicalTrials.gov

Time frame: through study completion, up to 4 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active MNS

Serious: 0/31 (0%)

Deaths: 0/31

Other adverse events (2 terms — click to expand)

Reaction	System	Active MNS
Skin Irritation	Skin and subcutaneous tissue disorders	—
Stimulation Limited Muscle Dexterity	Nervous system disorders	—

Data from ClinicalTrials.gov NCT05016765 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Median Nerve Stimulation for Treatment of Tics: A 4-Week Open Trial with Ecological Momentary Assessment.
   Iverson AM, Arbuckle AL, Song DY, Bihun EC, et al · · 2023 · cited 9× · PMID 37048629 · DOI 10.3390/jcm12072545