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

Sponsor

Xijing Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03705988

Collaborator

(none)

100

Enrollment

Arms

5.4

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tic Disorder, Childhood	Device: Cranial Electrotherapy Stimulation(CES) Device: sham Cranial Electrotherapy Stimulation( sham CES)	N/A

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 Design

Study Type:

Interventional

Anticipated 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)

Anticipated Study Start Date :

Oct 20, 2018

Anticipated Primary Completion Date :

Mar 1, 2019

Anticipated Study Completion Date :

Apr 1, 2019

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

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

Changes in Clinical Global Impression (CGI) score [8 weeks]
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 [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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Xijing Hospital

Investigators

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.