Clinical trial NCT03917953: Transcutaneous Electrical Acupoint Stimulation for the Treatment of ADHD
Official title: Transcutaneous Electrical Acupoint Stimulation for Treating Attention Deficit Hyperactivity Disorder: A Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Xian Children's Hospital
name: Shaanxi Hospital of Traditional Chinese Medicine
name: Air Force Military Medical University, China
First posted: 2019-04-17
Enrollment: 78
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 .

Eligibility criteria: 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.

Primary outcomes:
measure: the investigator-rated Clinical Global Impression-Improvement (CGI-I) scores
timeFrame: 4 weeks
Secondary outcomes:
measure: Clinical Global Impression-Improvement-Severity (CGI-S) score
timeFrame: 4 weeks
measure: Conners' Parent Rating Scales-Revised: Short Form (CPRS-R: S) score
timeFrame: 4 weeks
measure: Conners' Teacher Rating Scales-Revised: Short Form (CTRS-R: S) score
timeFrame: 4 weeks
measure: go/no-go task performances
timeFrame: 4 weeks
measure: the concentration of oxygenated hemoglobin within the prefrontal cortex
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xian Children's Hospital
state: Shaanxi
Study officials:
affiliation: First Afflicated Hospital Xian Jiaotong University
name: Yan Li, Dr.
role: PRINCIPAL_INVESTIGATOR
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citation: Zhuo L, Zhao X, Zhai Y, Zhao B, Tian L, Zhang Y, Wang X, Zhang T, Gan X, Yang C, Wang W, Gao W, Wang Q, Rohde LA, Zhang J, Li Y. Transcutaneous electrical acupoint stimulation for children with attention-deficit/hyperactivity disorder: a randomized clinical trial. Transl Psychiatry. 2022 Apr 21;12(1):165. doi: 10.1038/s41398-022-01914-0.