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ADHDNCT03917953

Transcutaneous Electrical Acupoint Stimulation for the Treatment of ADHD

A study testing Transcutaneous Electrical Acupoint Stimulation in people with ADHD, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
ADHD
What is being tested?
Transcutaneous Electrical Acupoint Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
78 participants
Where
1 siteChina
Study dates
1 Jul 2019to 17 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

China1 site

  • Xian Children's Hospital

    Xi'an, Shaanxi, 710000

Other trials in China

About this study

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

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.

Read the 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 .

Conditions
ADHD
Being tested
Transcutaneous Electrical Acupoint Stimulation
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcutaneous Electrical Acupoint StimulationDevice

    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).

Study groups in NCT03917953
Study groupRoleWhat they receive
Arm IExperimentalPatients receive transcutaneous electrical acupoint stimulation therapy twice weekly for 4 weeks.
Receives: Device: Transcutaneous Electrical Acupoint Stimulation
Arm IISham comparatorPatients receive sham transcutaneous electrical acupoint stimulation therapy twice weekly for 4 weeks.
Receives: Device: Transcutaneous Electrical Acupoint Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 4 weeks

Secondary outcomes (5)

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

    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.

    Measured: 4 weeks

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

    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.

    Measured: 4 weeks

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

    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.

    Measured: 4 weeks

  4. go/no-go task performances

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

    Measured: 4 weeks

  5. the concentration of oxygenated hemoglobin within the prefrontal cortex

    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.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2019
  2. Study start1 Jul 2019
  3. Primary completion1 Dec 2019
  4. Study completion17 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03917953
Sponsor's protocol ID
XJTU1AF-CRF-2018-003
Status last verified
Feb 2021
First submitted
14 Apr 2019
Last updated
15 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Thapar A, Cooper M. Attention deficit hyperactivity disorder. Lancet. 2016 Mar 19;387(10024):1240-50. doi: 10.1016/S0140-6736(15)00238-X. Epub 2015 Sep 17.

    PubMed 26386541

  • Lee MS, Choi TY, Kim JI, Kim L, Ernst E. Acupuncture for treating attention deficit hyperactivity disorder: a systematic review and meta-analysis. Chin J Integr Med. 2011 Apr;17(4):257-60. doi: 10.1007/s11655-011-0701-7. Epub 2011 Apr 21.

    PubMed 21509667

  • Liu Z, Liu Y, Xu H, He L, Chen Y, Fu L, Li N, Lu Y, Su T, Sun J, Wang J, Yue Z, Zhang W, Zhao J, Zhou Z, Wu J, Zhou K, Ai Y, Zhou J, Pang R, Wang Y, Qin Z, Yan S, Li H, Luo L, Liu B. Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial. JAMA. 2017 Jun 27;317(24):2493-2501. doi: 10.1001/jama.2017.7220.

    PubMed 28655016

  • Liu Z, Yan S, Wu J, He L, Li N, Dong G, Fang J, Fu W, Fu L, Sun J, Wang L, Wang S, Yang J, Zhang H, Zhang J, Zhao J, Zhou W, Zhou Z, Ai Y, Zhou K, Liu J, Xu H, Cai Y, Liu B. Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial. Ann Intern Med. 2016 Dec 6;165(11):761-769. doi: 10.7326/M15-3118. Epub 2016 Sep 13.

    PubMed 27618593

  • 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.

    PubMed 35449191

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous Electrical Acupoint Stimulation in people with ADHD, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the investigator-rated Clinical Global Impression-Improvement (CGI-I) scores (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03917953, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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