Dataset Information

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

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.

SUBMITTER: Leffa DT

PROVIDER: S-EPMC9350846 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Leffa Douglas Teixeira DT Grevet Eugenio Horacio EH Bau Claiton Henrique Dotto CHD Schneider Maitê M Ferrazza Carolina Prietto CP da Silva Roberta Francieli RF Miranda Marina Silva MS Picon Felipe F Teche Stefania Pigatto SP Sanches Paulo P Pereira Danton D Rubia Katya K Brunoni André Russowsky AR Camprodon Joan A JA Caumo Wolnei W Rohde Luis Augusto LA

JAMA psychiatry 20220901 9

<h4>Importance</h4>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.<h4>Objective</h4>To determine the efficacy and safety of home-based tDCS in treating inattention symptoms in adult patients with ADHD.<h4>Design, setting, and participants</h4>Randomized ...[more]

PMID: 35921102

Similar Datasets

Project description:ImportanceTranscranial direct current stimulation (tDCS) has the potential to be a sustainable treatment option in pediatric attention-deficit/hyperactivity disorder (ADHD), but rigorously controlled multicenter clinical trials using state-of-the-art stimulation techniques are lacking.ObjectivesTo determine effect sizes of changes in cognitive and clinical measures and to assess safety and tolerability in the course of optimized multichannel tDCS over prefrontal target regions in pediatric ADHD.Design, setting, and participantsIn the sham-controlled, double-blind, parallel-group randomized clinical trial E-StimADHD (Improving Neuropsychological Functions and Clinical Course in Children and Adolescents With ADHD With Anodal Transcranial Direct Current Stimulation of the Prefrontal Cortex: A Randomized, Double-Blind, Sham-Controlled, Parallel Group Trial Using an Uncertified Class IIa Device) with 2 independent study arms, participants were enrolled from September 15, 2018, to August 10, 2021, and follow-up was completed October 4, 2021. Data were analyzed January 26, 2022, to November 8, 2023. The trial was conducted at the departments of child and adolescent psychiatry or pediatrics of 5 university hospitals in Portugal and Germany. Youths 10 to 18 years of age with ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (all presentations), an IQ of at least 80, and the ability to refrain from stimulant medication during participation in the trial were eligible.InterventionsOptimized multichannel anodal tDCS or sham stimulation (1 mA, 20 minutes) targeting the left dorsolateral prefrontal cortex (lDLPFC; study A) or the right inferior frontal gyrus (rIFG; study B) was applied in 10 sessions, concurrent with performance on a cognitive target task (study A, working memory assessed in the n-back task; study B, interference control assessed in the flanker task).Main outcomes and measuresEffect sizes for changes in accuracy measures (d-prime or flanker effect) in the target tasks assessed after the intervention. Primary analyses were based on the modified intention-to-treat set.ResultsThis study included 69 youths (54 [78%] male) with a median age of 13.3 years (IQR, 11.9-14.9 years). Compared with sham tDCS, verum stimulation of the lDLPFC led to significantly lower working memory accuracy (effect size, -0.43 [95% CI, -0.68 to -0.17]; P = .001). Stimulation of the rIFG significantly improved interference control (effect size, 0.30 [95% CI, 0.04-0.56]; P = .02). Adverse events were mostly mild and transient and did not occur more often in the verum group. For example, the most frequent adverse events were headache (sham, n = 30; verum, n = 20), nasopharyngitis (sham, n = 11; verum, n = 5), and feeling of electric discharge (sham, n = 5; verum, n = 3).Conclusions and relevanceIn this randomized clinical trial, prefrontal anodal tDCS induced small- to medium-sized effects in youths with ADHD, with only mild and transient adverse events. The optimized multichannel montage chosen to target the lDLPFC, however, decreased working memory performance. This unexpected finding stresses the importance of incorporating insights from basic research on the mechanisms and preconditions of successful tDCS in future study designs to advance application of tDCS in pediatric ADHD.Trial registrationGerman Clinical Trials Register ID: DRKS00012659.

Project description:Transcranial direct current stimulation (tDCS) is a promising method for altering cortical excitability with clinical implications in neuropsychiatric diseases. Its application in neurodevelopmental disorders especially attention-deficit hyperactivity disorder (ADHD), is in early stage and promising but its effectiveness has not been systematically examined yet. We conducted a meta-analysis on the effectiveness of tDCS on the most studied neuropsychological symptoms of ADHD, which is the first reported meta-analysis of tDCS studies on ADHD. Data from 10 randomized controlled studies (including 11 separate experiments) targeting inhibitory control, and/or working memory (WM) in ADHD were included. Results show that overall tDCS significantly improved inhibitory control. Sub-analyses further show that dorsolateral prefrontal cortex (dlPFC) (but not right inferior frontal gyrus) tDCS and anodal (but not cathodal) tDCS significantly improved inhibitory control with a small effect size. Anodal dlPFC-tDCS had the largest significant effect on inhibitory control with a small-to-medium effect size. Additionally, a significant improving effect of tDCS on inhibitory control accuracy (but not response time) and WM speed (but not accuracy) were found. Overall, this meta-analysis supports a beneficial effect of tDCS on inhibitory control and WM in ADHD with a small-to-medium effect size. TDCS seems to be a promising method for improving neuropsychological and cognitive deficits in ADHD. However, there might be a dissociation between neuropsychological deficits and clinical symptoms of ADHD and therefore, the significance of this meta-analysis for clinical purposes is limited. Future studies should systematically evaluate the role of inter-individual factors (i.e., ADHD subtype, types of the deficit) and stimulation parameters (i.e., site, polarity, intensity, duration, repetition rate) on tDCS efficacy in ADHD population and examine whether benefits are long-term.

Project description:Importance:Aphasia is a debilitating language disorder for which behavioral speech therapy is the most efficient treatment, but therapy outcomes are variable and full recovery is not always achieved. It remains unclear if adjunctive brain stimulation (anodal transcranial direct current stimulation [A-tDCS]) applied during aphasia therapy can improve outcomes. Objective:To examine the futility of studying A-tDCS as an adjunctive intervention during speech therapy to improve speech production (naming) for individuals with long-term poststroke aphasia. Design, Setting, and Participants:Double-blinded, prospective randomized clinical trial using a futility design to test adjunctive A-tDCS during speech therapy. The setting was an outpatient clinic. Enrollment of individuals began in August 2012 and was completed in March 2017, and the duration of follow-up was 6 months. Analyses began in April 2017. The study recruited from a volunteer sample, and 89 patients were screened. Patients with long-term (>6 months) aphasia due to 1 previous left hemisphere stroke were enrolled. In comparing A-tDCS and sham tDCS, patients were matched based on site (University of South Carolina or Medical University of South Carolina), baseline age, type of aphasia, and aphasia severity. Interventions:Outpatient speech therapy for 3 weeks (15 sessions, 45 minutes each) combined with either A-tDCS vs sham tDCS applied to preserved left temporal lobe regions. Main Outcomes and Measures:The primary outcome was the ability to name common objects, assessed twice before and after therapy. Results:A total of 74 patients were enrolled. Participants had a mean (SD) age of 60 (10) years, had 15 (2) years of education, and were 44 (40) months from stroke onset. There were 52 men (70%) and 62 non-Hispanic white individuals (84%). Most were retired or not employed (59 [80%]). Broca aphasia was the most common aphasia type (39 [52.7%]). The adjusted mean (SE) change from pretreatment baseline in correct naming was 13.9 (2.4) words (95% CI, 9.0-18.7) for A-tDCS and 8.2 (2.2) words (95% CI, 3.8-12.6) for sham tDCS, with mean (SE) A-tDCS difference of 5.7 (3.3) words (95% CI, -0.9 to 12.3), indicating a relative 70% increase in correct naming for A-tDCS relative to sham. The futility hypothesis P value was .90, indicating failure to reject the null hypothesis and, therefore, providing no evidence that further study of A-tDCS is futile. No serious adverse events were associated with A-tDCS. Conclusions and Relevance:Our findings provide motivation to proceed with another trial to study the effect of A-tDCS on the outcome of aphasia treatment in individuals poststroke. Anodal tDCS during speech therapy is feasible and potentially transformative for aphasia treatment and should be further studied. Trial Registration:ClinicalTrials.gov Identifier: NCT01686373.

Dataset Information

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

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets