A Study of Cranial Electrotherapy Stimulation as an Add-on Treatment for Tic Disorders (SCATT)

NCT03705988 | Unknown FDA Device

• 1 other identifier: KY20182032-1
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Tic Disorder, Childhood

Keywords

Tic disorders; Tourette Syndrome; Cranial Electrotherapy Stimulation; CES

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Changes in Clinical Global Impression (CGI) score

  8 weeks

• Changes in The Hamilton Rating Scale for Anxiety (HAM-A) score

  8 weeks

• adverse effects

  8 weeks

Study Arms (2)

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.

Device: Cranial Electrotherapy Stimulation(CES)

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.

Device: sham Cranial Electrotherapy Stimulation( sham CES)

Interventions

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.

Intervention Arm

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.

Sham Arm

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 6-17 years old
• Diagnosed with TD, according to Intentional Classification of Diseases (ICD-10) criteria, currently in a phase of exacerbation.
• Presented to be lack of response to medication after 4 weeks of treatment

You may not qualify if:

• Physical illnesses, such as cholera, hepatolenticular degeneration, myoclonic epilepsy, drug-induced extrapyramidal symptoms and organic diseases
• Substance dependence and abuse
• Severe psychiatric disease, such as depression, bipolar disorder, schizophrenic disease,
• Risk for suicide or attempted suicide
• Researchers think that the patient is not suitable for the study

Sponsors & Collaborators

• Xijing Hospital: lead

Related Publications (10)

• 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.

  PMID: 28202705 BACKGROUND

• 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.

  PMID: 27375503 BACKGROUND

• 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.

  PMID: 3521373 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.

  PMID: 9214809 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.

  PMID: 16387997 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.

  PMID: 18348596 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.

  PMID: 22741094 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.

  PMID: 23538086 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.

  PMID: 24856571 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.

  PMID: 25546850 RESULT

MeSH Terms

Conditions

Tic Disorders; Tourette Syndrome

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders; Basal Ganglia Diseases; Brain Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• 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.

  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

Central Study Contacts

Wang Huaning, Doctor

CONTACT

(+86)13609161341; 13609161341@163.com

Wu Wenjun, Postgraduate

CONTACT

(+86)15829376756; wenjun104@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2018
• First Posted: October 15, 2018
• Study Start: October 20, 2018
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: October 15, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share