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

Primary Purpose

Tic Disorder, Childhood

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cranial Electrotherapy Stimulation(CES)
sham Cranial Electrotherapy Stimulation( sham CES)
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tic Disorder, Childhood focused on measuring Tic disorders, Tourette Syndrome, Cranial Electrotherapy Stimulation, CES

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Intervention Arm

    Sham Arm

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Changes in Clinical Global Impression (CGI) score
    Change in Clinical Global Impression (CGI) between groups at baseline and week 2, 4, 8.
    Changes in The Hamilton Rating Scale for Anxiety (HAM-A) score
    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.
    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.

    Full Information

    First Posted
    September 29, 2018
    Last Updated
    October 10, 2018
    Sponsor
    Xijing Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03705988
    Brief Title
    A Study of Cranial Electrotherapy Stimulation as an Add-on Treatment for Tic Disorders (SCATT)
    Acronym
    SCATT
    Official Title
    A Double-blind, Randomized, Sham-controlled Study of Cranial Electrotherapy Stimulation as an Add-on Treatment for Tic Disorders in Children and Adolescents(SCATT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 20, 2018 (Anticipated)
    Primary Completion Date
    March 1, 2019 (Anticipated)
    Study Completion Date
    April 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Xijing Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tic Disorder, Childhood
    Keywords
    Tic disorders, Tourette Syndrome, Cranial Electrotherapy Stimulation, CES

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Arm
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Sham Arm
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Cranial Electrotherapy Stimulation(CES)
    Intervention Description
    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 Type
    Device
    Intervention Name(s)
    sham Cranial Electrotherapy Stimulation( sham CES)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Changes in Yale Global Tic Severity Scale (YGTSS) score
    Description
    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.
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Changes in Clinical Global Impression (CGI) score
    Description
    Change in Clinical Global Impression (CGI) between groups at baseline and week 2, 4, 8.
    Time Frame
    8 weeks
    Title
    Changes in The Hamilton Rating Scale for Anxiety (HAM-A) score
    Description
    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.
    Time Frame
    8 weeks
    Title
    adverse effects
    Description
    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.
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wang Huaning, Doctor
    Phone
    (+86)13609161341
    Email
    13609161341@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wu Wenjun, Postgraduate
    Phone
    (+86)15829376756
    Email
    wenjun104@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wang Huaning, Doctor
    Organizational Affiliation
    Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Wu Wenjun, Master
    Organizational Affiliation
    Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Xi Min, Master
    Organizational Affiliation
    Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Wu Di, Master
    Organizational Affiliation
    Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Yan Qinghong, Bachelor
    Organizational Affiliation
    Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Patients are all children and adolescents. We decided not to share IPD to protect the personal information of the patients.
    Citations:
    PubMed Identifier
    28202705
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27375503
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    3521373
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    9214809
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    16387997
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    18348596
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    22741094
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    23538086
    Citation
    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.
    Results Reference
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    PubMed Identifier
    24856571
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    25546850
    Citation
    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.
    Results Reference
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    A Study of Cranial Electrotherapy Stimulation as an Add-on Treatment for Tic Disorders (SCATT)

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