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
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
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
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
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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
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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
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PubMed Identifier
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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
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PubMed Identifier
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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
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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
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PubMed Identifier
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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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