Clinical trial NCT03705988: A Study of Cranial Electrotherapy Stimulation as an Add-on Treatment for Tic Disorders (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
Overall status: UNKNOWN
Phase: NA
Conditions: Tic Disorder, Childhood
Keywords: Tic disorders
Tourette Syndrome
Cranial Electrotherapy Stimulation
CES
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in Yale Global Tic Severity Scale (YGTSS) score
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes in Clinical Global Impression (CGI) score
timeFrame: 8 weeks
measure: Changes in The Hamilton Rating Scale for Anxiety (HAM-A) score
timeFrame: 8 weeks
measure: adverse effects
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
name: Wang Huaning, Doctor
role: STUDY_CHAIR
affiliation: Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
name: Wu Wenjun, Master
role: STUDY_DIRECTOR
affiliation: Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
name: Xi Min, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
name: Wu Di, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
name: Yan Qinghong, Bachelor
role: PRINCIPAL_INVESTIGATOR
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