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Randomized Controlled Trial
. 2022 Sep 1;79(9):847-856.
doi: 10.1001/jamapsychiatry.2022.2055.

Transcranial Direct Current Stimulation vs Sham for the Treatment of Inattention in Adults With Attention-Deficit/Hyperactivity Disorder: The TUNED Randomized Clinical Trial

Douglas Teixeira Leffa  1   2 , Eugenio Horacio Grevet  1   2 , Claiton Henrique Dotto Bau  1   3 , Maitê Schneider  1   2 , Carolina Prietto Ferrazza  1   2 , Roberta Francieli da Silva  1   2 , Marina Silva Miranda  1   2 , Felipe Picon  1   2 , Stefania Pigatto Teche  1   2 , Paulo Sanches  4 , Danton Pereira  4 , Katya Rubia  5 , André Russowsky Brunoni  6 , Joan A Camprodon  7 , Wolnei Caumo  8   9   10 , Luis Augusto Rohde  1   2   11
Affiliations
Randomized Controlled Trial

Transcranial Direct Current Stimulation vs Sham for the Treatment of Inattention in Adults With Attention-Deficit/Hyperactivity Disorder: The TUNED Randomized Clinical Trial

Douglas Teixeira Leffa et al. JAMA Psychiatry. .

Abstract

Importance: Transcranial direct current stimulation (tDCS) may improve symptoms of inattention in adults with attention-deficit/hyperactivity disorder (ADHD). However, previous trials are characterized by small sample sizes, heterogeneous methodologies, and short treatment periods using clinic-based tDCS.

Objective: To determine the efficacy and safety of home-based tDCS in treating inattention symptoms in adult patients with ADHD.

Design, setting, and participants: Randomized, double-blind, parallel, sham-controlled clinical trial (tDCS for the Treatment of Inattention Symptoms in Adult Patients With ADHD [TUNED]), conducted from July 2019 through July 2021 in a single-center outpatient academic setting. Of 277 potential participants screened by phone, 150 were assessed for eligibility on site, and 64 were included. Participants were adults with ADHD, inattentive or combined subtype. Exclusion criteria included current stimulant drug treatment, current moderate to severe symptoms of depression or anxiety, diagnosis of bipolar disorder with a manic or depressive episode in the last year, diagnosis of schizophrenia or another psychotic disorder, and diagnosis of autism spectrum disorder; 55 of participants completed follow-up after 4 weeks.

Interventions: Thirty-minute daily sessions of home-based tDCS for 4 weeks, 2 mA anodal-right and cathodal-left prefrontal stimulation with 35-cm2 carbon electrodes.

Main outcomes and measures: Inattentive scores in the clinician-administered version of the Adult ADHD Self-report Scale version 1.1 (CASRS-I).

Results: Included in this trial were 64 participants with ADHD (31 [48%] inattentive presentation and 33 [52%] combined presentation), with a mean (SD) age of 38.3 (9.6) years. Thirty participants (47%) were women and 34 (53%) were men. Fifty-five finished the trial. At week 4, the mean (SD) inattention score, as measured with CASRS-I, was 18.88 (5.79) in the active tDCS group and 23.63 (3.97) in the sham tDCS group. Linear mixed-effects models revealed a statistically significant treatment by time interaction for CASRS-I (βinteraction = -3.18; 95% CI, -4.60 to -1.75; P < .001), showing decreased symptoms of inattention in the active tDCS group over the 3 assessments compared to the sham tDCS group. Mild adverse events were more frequent in the active tDCS group, particularly skin redness, headache, and scalp burn.

Conclusions and relevance: In this randomized clinical trial, daily treatment with a home-based tDCS device over 4 weeks improved attention in adult patients with ADHD who were not taking stimulant medication. Home-based tDCS could be a nonpharmacological alternative for patients with ADHD.

Trial registration: ClinicalTrials.gov Identifier: NCT04003740.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Leffa reported grants from Brain & Behavior Research Foundation, National Council for Scientific and Technological Development, and Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul during the conduct of the study. Dr Grevet served as a consultant to Shire/Takeda do Brasil and served on the speakers’ bureau of Novartis/Sandoz and Shire/Takeda in the last 3 years. BSc Ferrazza, Ms da Silva, BSc Miranda, and Ms Schneider reported grants from National Council for Scientific and Technological Development during the conduct of the study. Dr Sanches reported grants from Financiadora de Estudos e Projetos during the conduct of the study; in addition, Dr Sanches had a patent for BR 20 2015 016450 0 licensed to Quark Medical. Dr Rubia reported grants from Takeda pharmaceuticals, National Institute of Health Research and Medical Research Council, and personal fees from Supernus outside the submitted work. The tDCS device used in this study was developed and patented by Dr Sanches, MSc Pereira, and Dr Caumo, and these authors received royalties from Quark Medical (patent for BR 20 2015 016450 0 licensed to Quark Medical). Dr Camprodon is a member of the scientific advisory board of Hyka Therapeutics and Feelmore Labs and has been a consultant for Neuronetics. Dr Rohde has received grant or research support from, served as a consultant to, and served on the speakers’ bureau of Aché, Bial, Medice, Novartis/Sandoz, Pfizer/Upjohn, and Shire/Takeda in the last 3 years; the ADHD and Juvenile Bipolar Disorder Outpatient Programs chaired by Dr Rohde have received unrestricted educational and research support from Novartis/Sandoz and Shire/Takeda in the last 3 years; Dr Rhode has received authorship royalties from Oxford Press and ArtMed and grants from National Council for Scientific and Technological Development. MSc Pereira reported grants from Financiadora de Estudos e Projetos during the conduct of the study. Dr Camprodon reported other support from Hyka and other from Feelmore Labs outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Diagram
ASSIST indicates the Alcohol, Smoking, and Substance Involvement Screening Test; BAI, Beck Anxiety Inventory; BD, bipolar disorder; BDI, Beck Depression Inventory-II; CASRS-I, clinician-administered version of the Adult ADHD Self-report Scale version 1.1, inattention section; tDCS, transcranial direct current stimulation.
Figure 2.
Figure 2.. Changes in Primary Outcome
Figure shows clinician-administered version of the Adult ADHD Self-report Scale version 1.1, inattention section (CASRS-I) scores over time. Bars represent mean scores ±1 SD of inattention symptoms measured with CASRS-I at baseline, week 2, and week 4. Lines represent individual patients’ scores. CASRS-I scores range from 0 to 36, with higher scores indicating more symptoms of inattention. Two participants in sham transcranial direct current stimulation (tDCS) and 7 in the active tDCS group dropped out of the study before week 2. One participant in the active tDCS group was not available for assessment in week 2, but continued in the trial up to week 4. Linear mixed-effects models revealed a statistically significant treatment by time interaction for CASRS-I (β interaction = −3.18; 95% CI, −4.60 to −1.75; P < .001), showing decreased symptoms of inattention in the active tDCS group over the 3 assessments when compared to sham tDCS.
Figure 3.
Figure 3.. Stimulation Parameters
Figure shows the stimulation parameters. Each line represents the mean contact impedance (dark blue) and mean current intensity (cyan) from all sessions performed by each participant submitted to active transcranial direct current stimulation (tDCS) or sham tDCS. A, The current intensity was adequately maintained at 2 mA during the entire sessions performed by each participant. Contact impedance was maintained within safety limits. B, The 30-second ramp-up (0-2 mA) stimulation, followed by the 30-second ramp-down (2-0 mA), in the beginning, middle, and end of sessions in the sham group.
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