Transcutaneous Electrical Acupoint Stimulation for the Treatment of ADHD

Xi'an Jiaotong University

Status: Completed

Conditions: ADHD

Treatments: Device: Transcutaneous Electrical Acupoint Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03917953

XJTU1AF-CRF-2018-003

Details and patient eligibility

About

RATIONALE: Transcutaneous electrical acupoint stimulation may improve attention deficit hyperactivity disorder (ADHD).

PURPOSE: This randomized-controlled trial study of treating attention deficit hyperactivity disorder of school-aged children with transcutaneous electrical acupoint stimulation to see how well it works compared to sham transcutaneous electrical acupoint stimulation.

Full description

OBJECTIVES:

Primary

To determine whether true transcutaneous electrical acupoint stimulation(TEAS) administered twice weekly for 4 weeks (8 sessions) compared to sham TEAS causes a significant improvement in symptoms of ADHD according to the investigator-rated Clinical Global Impression-Improvement (CGI-I) scores at week 4.

Secondary

To evaluate the changes from baseline to week 4 of Clinical Global Impressions Scale-Severity of Illness (CGI-S)，Conners'Parent Rating Scales-Revised: Short Form (CPRS-R: S) score, Conners'Teacher Rating Scales-Revised: Short Form (CTRS-R: S) score, go/no-go task performances, and the concentration of oxygenated hemoglobin within the prefrontal cortex.

OUTLINE: This is a single-center study. Patients are randomized to two treatment arms.

Arm I: Patients receive TEAS twice weekly for 4 weeks . Arm II: Patients receive sham TEAS twice weekly for 4 weeks .

Enrollment: 78 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must be conform to ADHD clinical diagnostic criteria (DSM-V).
• Patients' ages are between 6~12 years old.
• An informed written consent from parents and participants

Exclusion criteria

• Patients have a history of illness that concomitant with other mental and neurological disorders.
• Patients's IQ score are lower than 75.
• Patients have had prior TEAS or other acupoints-associated treatment experiences.
• Left handedness.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

78 participants in 2 patient groups

Arm I

Experimental group

Description:

Patients receive transcutaneous electrical acupoint stimulation therapy twice weekly for 4 weeks.

Treatment:

Device: Transcutaneous Electrical Acupoint Stimulation

Arm II

Sham Comparator group

Description:

Patients receive sham transcutaneous electrical acupoint stimulation therapy twice weekly for 4 weeks.

Treatment:

Device: Transcutaneous Electrical Acupoint Stimulation