NCT03705988

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

A Double-blind, Randomized, Sham-controlled Study of Cranial Electrotherapy Stimulation as an Add-on Treatment for Tic Disorders in Children and Adolescents(SCATT)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tic Disorder, Childhood

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-10-20
• Primary completion: 2019-03-01
• Completion: 2019-04-01
• First posted: 2018-10-15
• Last updated: 2018-10-15

Regulatory

• FDA-regulated device study