N/A
Completed N=31
Open-label MNS for Tourette Syndrome
Tourette Syndrome · Tic Disorder, Chronic Motor or Vocal
Source: ClinicalTrials.gov NCT05016765 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Time Spent Using the Device Per Day of Use — 49.6 minutes per day
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Spent Using the Device Per Day of Use |
49.6 | — |
| PRIMARY Time Spent Using the Device (Days Per Week) |
1.5 | — |
| PRIMARY Plan to Continue MNS (Median Nerve Stimulation) |
21 | — |
| PRIMARY Change in Tic Frequency With Stimulation |
3.1; 2.1 | <0.001 sig |
| PRIMARY Change in Tic Intensity With Stimulation |
2.9; 2.0 | <0.001 sig |
| PRIMARY Discomfort |
1.0 | — |
| SECONDARY CGI-I (Clinical Global Impression--Improvement) |
3.1 | — |
| SECONDARY CGI Efficacy Index: Side Effects |
1.2 | — |
| SECONDARY Mean Therapeutic Effect During Stimulator Use |
1.5 | — |
| SECONDARY Change in Self-reported Tic Severity |
35.4; 34.6 | 0.84 |
| SECONDARY Self-reported Duration of MNS Benefit, in Minutes |
15 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05016765). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.