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NCT Number: NCT03917953

Transcutaneous Electrical Acupoint Stimulation for the Treatment of ADHD

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xian Children's Hospital

Xi'an, Shaanxi, 710000, China

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous electrical acupoint stimulation

Device

Patients in the experimental group will be treated for 20 min TEAS, twice a week, for a total of 4 weeks of treatment.The same intervention was performed in the sham group (electrode patches were attached at corresponding acupoints without electrical stimulation).

Acupoint selection: baihui (GV 20), taichong (LR 3), taixi (KI 3).

Primary outcomes

  1. the investigator-rated Clinical Global Impression-Improvement (CGI-I) scores

    Time frame: 4 weeks

    The CGI-Improvement scale was used to evaluate the improvement, maintenance, or worsening of subjects' symptoms compared to baseline. The CGI-Improvement Scale includes seven options for scoring: 1 very much improved; 2 much improved; 3 minimally improved; 4 no change; 5 minimally worse; 6 much worse; and 7 very much worse. Clinical response at week 4 was defined as a rating of "much" or "very much improved" (1 or 2), which is considered a clinically meaningful response.

Secondary outcomes

  1. Clinical Global Impression-Improvement-Severity (CGI-S) score

    Time frame: 4 weeks

    The CGI-S includes seven options for scoring: 1 normal, not at all ill; 2 borderline mentally ill; 3 mildly ill; 4 moderately ill; 5 markedly ill; 6 severely ill; and 7 among the most extremely ill patients.

  2. Conners' Parent Rating Scales-Revised: Short Form (CPRS-R: S) score

    Time frame: 4 weeks

    The CTRS-R:S is a teacher-rated 27-item 4-point Likert rating scale that contains items on ADHD and comorbid conditions (i.e., problems with conduct, emotion, anger control, and anxiety) in the home setting.

  3. Conners' Teacher Rating Scales-Revised: Short Form (CTRS-R: S) score

    Time frame: 4 weeks

    The CTRS-R:S is a teacher-rated 28-item 4-point Likert rating scale that contains items on ADHD and comorbid conditions (i.e., problems with conduct, emotion, anger control, and anxiety) in the school setting.

  4. go/no-go task performances

    Time frame: 4 weeks

    The accuracy (ACC) for go and no-go trials and reaction time (RT) of go trials were computed for each go/no-go block.

  5. the concentration of oxygenated hemoglobin within the prefrontal cortex

    Time frame: 4 weeks

    fNIRS was used to monitor the brain response when the participants performed a go/no-go task before and after TEAS or sham TEAS treatment. The ETG-4000 (Hitachi Medical Corporation, Japan) multichannel fNIRS system to measure the relative concentration changes in oxygenated hemoglobin (HbO), with two wavelengths of nearinfrared light (695 and 830 nm). HbO signal is more sensitive to changes in cerebral blood flow than deoxygenated hemoglobin and total hemoglobin signals. Specifically, we used a 3 × 11 multichannel patch that consisted of 17 emitters and 16 detectors arranged alternately at an inter-probe distance of 3 cm forming 52 channels.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Collaborators

  • Air Force Military Medical University, China
  • Shaanxi Hospital of Traditional Chinese Medicine
  • Xian Children's Hospital

Registry information

Official study title

Transcutaneous Electrical Acupoint Stimulation for Treating Attention Deficit Hyperactivity Disorder: A Prospective, Randomized, Controlled Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 17, 2019
Registry last updated
Mar 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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