| Autor: |
McGough, James J., Sturm, Alexandra, Cowen, Jennifer, Tung, Kelly, Salgari, Giulia C., Leuchter, Andrew F., Cook, Ian A., Sugar, Catherine A., Loo, Sandra K. |
| Jazyk: |
angličtina |
| Rok vydání: |
2019 |
| Předmět: |
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| Popis: |
OBJECTIVE: Trigeminal nerve stimulation (TNS), a minimal risk, non-invasive neuromodulation method, has showed potential benefits for attention-deficit/hyperactivity disorder (ADHD) in an unblinded open study. This blinded sham-controlled trial was conducted to assess efficacy and safety of TNS for ADHD, as well as potential changes in brain spectral power using resting-state quantitative electroencephalography (qEEG). METHOD: 62 children aged 8–12 years, with full-scale IQ ≥ 85 and KSADS-diagnosed ADHD, were randomized to four weeks nightly treatment with active or sham TNS, followed by one-week without intervention. Assessments included weekly clinician-administered ADHD-Rating Scales (ADHD-RS) and Clinical Global Impression (CGI) scales, and qEEG at baseline and week 4. RESULTS: ADHD-RS totals showed significant group-by-time interactions (F = 8.12, df = 1/228, p = .005); week 4 Cohen’s d = .5. CGI-Improvement also favored active treatment (Chisq = 8.75, df = 1/168, p = .003); number-needed-to-treat (NNT) = 3. Resting-state qEEG showed increased spectral power in right frontal and frontal midline frequency bands with active TNS. Neither group had clinically meaningful adverse events. CONCLUSION: This study demonstrates TNS efficacy for ADHD in a blinded sham-controlled trial, with estimated treatment effect size similar to non-stimulants. TNS is well-tolerated and minimal risk. Additional research should examine treatment response durability and potential impact on brain development with sustained use. CLINICAL TRIAL REGISTRATION INFORMATION: Developmental Pilot Study of External Trigeminal Nerve Stimulation for ADHD; http://clinicaltrials.gov/; NCT02155608. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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