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

Not Applicable

• Conditions: Tic Disorder, Childhood

• Registration Number: NCT03705988
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2018-09
• Study First Submitted: 2018-09-29
• Study First Submitted QC: 2018-10-10
• Last Update Submitted: 2018-10-10
• Study First Posted: 2018-10-15
• Last Update Posted: 2018-10-15
• Study Start: 2018-10-20
• Primary Completion: 2019-03-01
• Study Completion: 2019-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Yale Global Tic Severity Scale (YGTSS) score	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

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