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Tic disorders is recognized as a neuropsychiatric disease. The treatments of tic disorders include drug therapy, psychotherapy and physical therapy. As a non-invasive therapy, cranial electrotherapy stimulation(CES) is approved to have few side effects and applied in various areas, especially in psychiatric diseases. However, up to now there have been no results about the effects of CES in the treatment of tic disorders.The investigators hope CES could offer a useful approach for treating tic disorders.
The investigators will conduct a randomized, double-blind, sham-controlled trial to determine the efficacy of CES as an add-on treatment for tic disorders (SCATT). The study will be conducted at an outpatient, single-center academic setting. A total of 100 patients aged 6 to 17 years with tic disorders and lack of clinical response to 4 weeks' pharmacotherapy will be enrolled. Patients will be randomly into 2 groups and given 4 weeks' treatment, including 40 daily 30-minute sessions of active CES(500μA~2mA) or sham CES(lower than 100μA) on weekdays. Change in Yale Global Tic Severity Scale (YGTSS) is considered to be the primary outcome. The secondary outcome is the changes in Clinical Global Impression (CGI) and Hamilton Anxiety Scale (HAMA). Assessments will be performed at baseline, week 2, week 4 and week 8. Adverse events(AE) will be also evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Participants will receive 40 sessions in 4 weeks, for twice daily on weekdays from Monday to Friday. Each session will be performed for 30 minutes. The current intensity will be adjusted continuously from 500 μA~2mA. |
|
| Sham Arm | Sham Comparator | Participants will receive 40 sessions in 4 weeks, for twice daily on weekdays from Monday to Friday. Each session will be performed for 30 minutes. The current intensity will be adjusted lower than 100 μA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cranial Electrotherapy Stimulation(CES) | Device | Cranial electrotherapy stimulation (CES) has been known as a kind of noninvasive treatment, which applies pulsed, weak electrical current to head through two electrodes that placed on the earlobes. The current intensity could be adjusted continuously from 500 μA~2mA. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Yale Global Tic Severity Scale (YGTSS) score | Change in Yale Global Tic Severity Scale (YGTSS) at baseline and week 2, 4, 8. The YGTSS is applied by means of a semistructured interview with multiple informants (generally, the parents) who assess the child's tics over a period of at least one week. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Clinical Global Impression (CGI) score | Change in Clinical Global Impression (CGI) between groups at baseline and week 2, 4, 8. | 8 weeks |
| Changes in The Hamilton Rating Scale for Anxiety (HAM-A) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Huaning, Doctor | Contact | (+86)13609161341 | 13609161341@163.com | |
| Wu Wenjun, Postgraduate | Contact | (+86)15829376756 | wenjun104@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Wang Huaning, Doctor | Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China. | Study Chair |
| Wu Wenjun, Master | Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China. |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28202705 | Background | Sukhodolsky DG, Woods DW, Piacentini J, Wilhelm S, Peterson AL, Katsovich L, Dziura J, Walkup JT, Scahill L. Moderators and predictors of response to behavior therapy for tics in Tourette syndrome. Neurology. 2017 Mar 14;88(11):1029-1036. doi: 10.1212/WNL.0000000000003710. Epub 2017 Feb 15. | |
| 27375503 | Background |
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Patients are all children and adolescents. We decided not to share IPD to protect the personal information of the patients.
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| ID | Term |
|---|---|
| D013981 | Tic Disorders |
| D005879 | Tourette Syndrome |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D065886 | Neurodevelopmental Disorders |
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|
| sham Cranial Electrotherapy Stimulation( sham CES) | Device | Cranial electrotherapy stimulation (CES) has been known as a kind of noninvasive treatment, which applies pulsed, weak electrical current to head through two electrodes that placed on the earlobes. The sham CES devices were identical to the active device, except the ear clip electrodes emit electricity intensity of lower than 100 μA. |
|
Change in The Hamilton Rating Scale for Anxiety (HAM-A) at baseline and week 2, 4, 8.
The HAM-A consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Scores range from 0 to 56 where 14-17 indicates mild anxiety, 18-24 indicates moderate anxiety and scores of 25 and over indicate severe anxiety.
| 8 weeks |
| adverse effects | Any adverse event notified spontaneously by the subject, or observed by the research team will be recorded on the form designed for this purpose. The researcher will classify the intensity of adverse events in accordance with the following scale: Mild: some discomfort experienced but not such as to interrupt normal daily activity. Moderate: sufficient discomfort to reduce or notably affect normal daily activity. Severe: provoking incapacity to work or perform normal daily activity. | 8 weeks |
| Study Director |
| Xi Min, Master | Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China. | Principal Investigator |
| Wu Di, Master | Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China. | Principal Investigator |
| Yan Qinghong, Bachelor | Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China. | Principal Investigator |
| Eapen V, Cavanna AE, Robertson MM. Comorbidities, Social Impact, and Quality of Life in Tourette Syndrome. Front Psychiatry. 2016 Jun 6;7:97. doi: 10.3389/fpsyt.2016.00097. eCollection 2016. |
| 3521373 | Result | Schmitt R, Capo T, Boyd E. Cranial electrotherapy stimulation as a treatment for anxiety in chemically dependent persons. Alcohol Clin Exp Res. 1986 Mar-Apr;10(2):158-60. doi: 10.1111/j.1530-0277.1986.tb05064.x. |
| 9214809 | Result | Ferdjallah M, Bostick FX Jr, Barr RE. Potential and current density distributions of cranial electrotherapy stimulation (CES) in a four-concentric-spheres model. IEEE Trans Biomed Eng. 1996 Sep;43(9):939-43. doi: 10.1109/10.532128. |
| 16387997 | Result | Childs A. Cranial electrotherapy stimulation reduces aggression in a violent retarded population: a preliminary report. J Neuropsychiatry Clin Neurosci. 2005 Fall;17(4):548-51. doi: 10.1176/jnp.17.4.548. |
| 18348596 | Result | Bystritsky A, Kerwin L, Feusner J. A pilot study of cranial electrotherapy stimulation for generalized anxiety disorder. J Clin Psychiatry. 2008 Mar;69(3):412-7. doi: 10.4088/jcp.v69n0311. |
| 22741094 | Result | Feusner JD, Madsen S, Moody TD, Bohon C, Hembacher E, Bookheimer SY, Bystritsky A. Effects of cranial electrotherapy stimulation on resting state brain activity. Brain Behav. 2012 May;2(3):211-20. doi: 10.1002/brb3.45. |
| 23538086 | Result | Kirsch DL, Nichols F. Cranial electrotherapy stimulation for treatment of anxiety, depression, and insomnia. Psychiatr Clin North Am. 2013 Mar;36(1):169-76. doi: 10.1016/j.psc.2013.01.006. |
| 24856571 | Result | Barclay TH, Barclay RD. A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression. J Affect Disord. 2014 Aug;164:171-7. doi: 10.1016/j.jad.2014.04.029. Epub 2014 Apr 21. |
| 25546850 | Result | Qiao J, Weng S, Wang P, Long J, Wang Z. Normalization of Intrinsic Neural Circuits Governing Tourette's Syndrome Using Cranial Electrotherapy Stimulation. IEEE Trans Biomed Eng. 2015 May;62(5):1272-80. doi: 10.1109/TBME.2014.2385151. Epub 2014 Dec 22. |
| D001523 | Mental Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |