Open-label MNS for Tourette Syndrome

NCT05016765 | Completed Results FDA Device

• 2 other identifiers: Open-label MNSUL1TR002345
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tourette Syndrome; Tic Disorder, Chronic Motor or Vocal

Keywords

Tourette; tic; Transcutaneous Electric Nerve Stimulation; Median Nerve

Outcome Measures

Primary Outcomes (6)

• Time Spent Using the Device Per Day of Use

  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

  At study conclusion, up to 4 weeks

• Time Spent Using the Device (Days Per Week)

  Number of days per week the device was used

  At study conclusion, up to 4 weeks

• Plan to Continue MNS (Median Nerve Stimulation)

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

  At study conclusion, up to 1 month

• Change in Tic Frequency With Stimulation

  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 .

  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

  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.

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

• Discomfort

  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 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.

  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.

Secondary Outcomes (5)

• CGI-I (Clinical Global Impression--Improvement)

  At study conclusion, up to 4 weeks

• CGI Efficacy Index: Side Effects

  At study conclusion, up to 4 weeks

• Mean Therapeutic Effect During Stimulator Use

  At study conclusion, up to 4 weeks

• Change in Self-reported Tic Severity

  At beginning of study participation or up to 2 weeks prior, and again at end of study participation up to 4 weeks

• Self-reported Duration of MNS Benefit, in Minutes

  Monitored over the entire period of study participation, up to 4 weeks

Study Arms (1)

Active MNS

EXPERIMENTAL

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

Device: Active, self-directed electrical stimulation of the median nerve

Interventions

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

Electrical stimulation of the median nerve (12 Hz, pulse width 200µs), initially at the threshold needed to see movement of the right thumb with stimulation. After initial training with the device and education in the rationale for suprathreshold stimulation, participants will choose timing and intensity of stimulation based on their momentary symptom severity and their experience with the treatment since the beginning of the study. Participant can choose right or left median nerve (we will suggest their nondominant hand to minimize interference with daily activities).

Also known as: Rhythmic MNS

Active MNS

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Washington University School of Medicine, Movement Disorders Center

St Louis, Missouri, 63110, United States

Location

Related Publications (7)

• Evans J, Seri S, Cavanna AE. The effects of Gilles de la Tourette syndrome and other chronic tic disorders on quality of life across the lifespan: a systematic review. Eur Child Adolesc Psychiatry. 2016 Sep;25(9):939-48. doi: 10.1007/s00787-016-0823-8. Epub 2016 Feb 15.

  PMID: 26880181 BACKGROUND

• Thomas R, Cavanna AE. The pharmacology of Tourette syndrome. J Neural Transm (Vienna). 2013 Apr;120(4):689-94. doi: 10.1007/s00702-013-0979-z. Epub 2013 Jan 30.

  PMID: 23361655 BACKGROUND

• Scahill L, Woods DW, Himle MB, Peterson AL, Wilhelm S, Piacentini JC, McNaught K, Walkup JT, Mink JW. Current controversies on the role of behavior therapy in Tourette syndrome. Mov Disord. 2013 Aug;28(9):1179-83. doi: 10.1002/mds.25488. Epub 2013 May 16.

  PMID: 23681719 BACKGROUND

• Lin L, Stamm K, Christidis P, APA Center for Workforce Studies. 2015 County-Level Analysis of U.S. Licensed Psychologists and Health Indicators [online]. 2016. Available at: http://www.apa.org/workforce/publications/15-county-analysis/index.aspx?tab=1 Accessed 9/29/2017.

  BACKGROUND

• Cuenca J, Glazebrook C, Kendall T, Hedderly T, Heyman I, Jackson G, Murphy T, Rickards H, Robertson M, Stern J, Trayner P, Hollis C. Perceptions of treatment for tics among young people with Tourette syndrome and their parents: a mixed methods study. BMC Psychiatry. 2015 Mar 11;15:46. doi: 10.1186/s12888-015-0430-0.

  PMID: 25879205 BACKGROUND

• Morera Maiquez B, Sigurdsson HP, Dyke K, Clarke E, McGrath P, Pasche M, Rajendran A, Jackson GM, Jackson SR. Entraining Movement-Related Brain Oscillations to Suppress Tics in Tourette Syndrome. Curr Biol. 2020 Jun 22;30(12):2334-2342.e3. doi: 10.1016/j.cub.2020.04.044. Epub 2020 Jun 4.

  PMID: 32502412 BACKGROUND

• Iverson AM, Arbuckle AL, Song DY, Bihun EC, Black KJ. Median Nerve Stimulation for Treatment of Tics: A 4-Week Open Trial with Ecological Momentary Assessment. J Clin Med. 2023 Mar 28;12(7):2545. doi: 10.3390/jcm12072545.

  PMID: 37048629 DERIVED

Related Links

• Invitation to participate

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders; Tics

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kevin J. Black, M.D.
• Organization: Washington University School of Medicine

kevin@wustl.edu

1-314-362-5041

Study Officials

• Kevin J Black, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All participants will receive MNS at 12 Hz, pulse width 200µs. After initial threshold determination and training on device usage, individual participants will choose duration and intensity of treatment depending on their momentary symptom severity and history of response to treatment.

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 23, 2021
• Study Start: November 18, 2021
• Primary Completion: April 27, 2022
• Study Completion: April 27, 2022
• Last Updated: October 5, 2023
• Results First Posted: October 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Available within 6 months after publication of key results
• Access Criteria: Individual participant data (IPD) will be freely available under a CC0 license (Creative Commons public domain dedication, https://creativecommons.org/publicdomain/zero/1.0/).

Locations

US (1)