Transcutaneous electrical acupoint stimulation for children with attention-deficit/hyperactivity disorder: a randomized clinical trial

Abstract

Little is known about the effects of transcutaneous electrical acupoint stimulation (TEAS) for children with attention-deficit/hyperactivity disorder (ADHD). Here, we carried out a 4 week randomized clinical trial in which patients aged 6-12 years old with an ADHD diagnosis received TEAS or sham TEAS. The primary outcome measure was the investigator-rated Clinical Global Impression-Improvement (CGI-I) score at week 4. Secondary outcomes included changes from baseline to week 4 in the investigator-rated Clinical Global Impression-Severity of Illness (CGI-S) score, the Conners' Parent/Teacher Rating Scales-Revised: Short Form (CPRS-R: S/CTRS-R: S) score, go/no-go task performance, and functional near-infrared spectroscopy (fNIRS)-based oxygenated hemoglobin level within the prefrontal cortex. At week 4, the CGI-I score indicated improvement in 33.3% of the TEAS group compared with 7.7% of the sham group (P = 0.005). The TEAS group had a greater decrease in the mean CGI-S score (-0.87) than the sham TEAS group (-0.28) (P = 0.003). A greater enhancement in the mean cerebral oxygenated hemoglobin within the prefrontal cortex was found in the TEAS group (0.099 mM mm) compared with the sham TEAS group (0.005 mM mm) (P < 0.001). CPRS-R: S score, CTRS-R: S score, and go/no-go performance exhibited no significant improvement after TEAS treatment. The manipulation-associated adverse events were uncommon in both groups, and events were very mild. Our results show that noninvasive TEAS significantly improved general symptoms and increased prefrontal cortex blood flow within 4 weeks for children with ADHD. Further clinical trials are required to understand the long-term efficacy in a larger clinical sample. This trial was registered on ClinicalTrials.gov (NCT03917953).

Fig. 1. CONSORT flow diagram of participants through the trial.

^aReasons for children who did not meet inclusion criteria or did not attend study treatments are not available. ^bTheir residential addresses were too far from the hospital to attend this study. ADHD attention-deficit/hyperactivity disorder, TEAS transcutaneous electrical acupoint stimulation, ITT intention-to-treat, PP planned per-protocol.

Fig. 2. Study design.

A Flowchart showing the study design of the TEAS intervention and response evaluation. B Illustration of acupoint locations for TEAS and sham TEAS. The rose-red triangle is the Baihui acupoint in the left panel, and the rose-red circles are the Taichong and Taixi acupoints in the middle and right panels, respectively. C Schematic diagram of the go/no-go task. HbO was measured by fNIRS in the TEAS and sham TEAS groups performing the go/no-go task.

Fig. 3. Spatial profiles of fNIRS channels and HbO signals for CH 37.

A Map of 52-channel fNIRS used in the present trial. Each yellow square on the standard brain model represents an fNIRS channel, each red dot represents an emitter, and each blue dot represents a detector. Left-, front- and right-side views of the probe arrangements in a 52-channel fNIRS. B Violin plots of HbO signals for CH 37 showed no significant differences at baseline between the TEAS (n = 39) and sham TEAS (n = 39) groups (left panel) but increased brain responses were observed after the 4 weeks of treatment in the TEAS group compared to the sham TEAS group (middle and right panels) (MMRM and Wilcoxon rank-sum test). Hollow circles denote individual data points, solid black lines denote medians, and dashed gray lines denote quartiles. NS not significant. ***p < 0.001.