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

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ClinicalTrials.gov Identifier: NCT03705988
Recruitment Status : Not yet recruiting
First Posted : October 15, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

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.

Condition or disease Intervention/treatment Phase
Tic Disorder, Childhood Device: Cranial Electrotherapy Stimulation(CES) Device: sham Cranial Electrotherapy Stimulation( sham CES) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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)
Estimated Study Start Date : October 20, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : April 1, 2019

Arm Intervention/treatment
Experimental: Intervention Arm
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)
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.

Sham Comparator: Sham Arm
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)
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 Measures :
  1. Changes in Yale Global Tic Severity Scale (YGTSS) score [ Time Frame: 8 weeks ]
    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 :
  1. Changes in Clinical Global Impression (CGI) score [ Time Frame: 8 weeks ]
    Change in Clinical Global Impression (CGI) between groups at baseline and week 2, 4, 8.

  2. Changes in The Hamilton Rating Scale for Anxiety (HAM-A) score [ Time Frame: 8 weeks ]

    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.


  3. adverse effects [ Time Frame: 8 weeks ]

    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.




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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03705988


Contacts
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Contact: Wang Huaning, Doctor (+86)13609161341 13609161341@163.com
Contact: Wu Wenjun, Postgraduate (+86)15829376756 wenjun104@126.com

Sponsors and Collaborators
Xijing Hospital
Investigators
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Study Chair: Wang Huaning, Doctor Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
Study Director: Wu Wenjun, Master Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
Principal Investigator: 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.

Publications of Results:

Other Publications:
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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03705988    
Other Study ID Numbers: KY20182032-1
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Patients are all children and adolescents. We decided not to share IPD to protect the personal information of the patients.

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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
Keywords provided by Xijing Hospital:
Tic disorders
Tourette Syndrome
Cranial Electrotherapy Stimulation
CES
Additional relevant MeSH terms:
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Tics
Tic Disorders
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders