Brain Stimulation for Dyslexia
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Vanderbilt University
Must not be taking: Psychotropics, Seizure meds, Stroke meds
Disqualifiers: Intellectual disability, Neurologic pathology, Psychiatric disorders, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this project is to address the urgent need for effective, scalable adult literacy interventions by integrating breakthroughs in two separate fields: 1.) the brain network science of resilience to reading disorders and 2.) high-definition non-invasive brain network stimulation. This study will first establish the efficacy of a novel, noninvasive stimulation protocol on reading behavior and brain metrics; then will determine how stimulation-induced effects interact with baseline reading comprehension ability; and lastly, will identify whether stimulation-induced effects are more clinically-beneficial than canonical behavioral interventions. Results may change the foundation for how we treat low adult literacy, and have the potential for wider reaching impacts on non-invasive stimulation protocols for other clinical disorders.
Will I have to stop taking my current medications?
The trial excludes participants who are taking psychotropic medications or medications known to increase the risk of seizures or strokes. If you are on such medications, you may need to stop taking them to participate.
What data supports the effectiveness of this treatment for dyslexia?
Research shows that transcranial direct current stimulation (tDCS), a part of the treatment, has been used to help with motor disabilities and depression by influencing brain activity. This suggests it might also help with dyslexia by potentially improving brain function related to reading and language skills.
12345Is brain stimulation for dyslexia safe for humans?
Transcranial electrical stimulation (TES), including transcranial direct current stimulation (tDCS), is generally considered safe in humans, with no serious adverse events reported in over 18,000 sessions. Mild side effects like headaches and skin sensations are common, but serious issues are rare.
678910How does the brain stimulation treatment for dyslexia differ from other treatments?
This treatment uses non-invasive brain stimulation, specifically transcranial direct current stimulation (tDCS), to enhance reading abilities by targeting underactive brain areas involved in reading. Unlike other treatments, it shows promise in providing long-lasting improvements in reading skills for individuals with dyslexia, especially when combined with reading training.
1112131415Eligibility Criteria
This trial is for right-handed, native English-speaking adults aged 18-40 with dyslexia. Participants must not have a low IQ, developmental disorders, visual or hearing impairments that can't be corrected, metal devices in their body, recent migraines, severe fatigue or psychiatric issues. They should not be pregnant and mustn't take certain medications.Inclusion Criteria
I am right-handed and only speak English.
I am between 18 and 40 years old.
Exclusion Criteria
I have a known neurological condition such as epilepsy or brain injury.
I have been recently diagnosed with migraines.
Hair styles that do not allow for proper EEG net fitting, or that pose potential risks for damage to EEG net
+14 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Establish baseline behavior and brain measures of the individual
1 day
1 visit (in-person, 3.5 hours)
Intervention
Behavioral and non-invasive stimulation intervention, including MRI and EEG sessions
1 day
1 visit (in-person, 3 hours)
Follow-up Assessment
Establish prolonged intervention effects using behavior and brain measures
1 day
1 visit (in-person, 2.5 hours)
Long-term Follow-up
Participants are monitored for changes in reading comprehension and brain activations
12 months
Participant Groups
The study tests the effect of non-invasive brain stimulation on reading comprehension in adults with dyslexia. It compares different types of stimulations (RLN and CCN) against a sham intervention to see which improves reading skills and brain function.
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Reading and Language Network (RLN)Experimental Treatment1 Intervention
Participants receiving real stimulation to the left angular gyrus and left temporal pole.
Group II: RLN and CCNExperimental Treatment1 Intervention
Participants receiving real stimulation to the left dorsolateral prefrontal cortex and left angular gyrus.
Group III: Cognitive Control Network (CCN)Experimental Treatment1 Intervention
Participants receiving real stimulation to the bilateral dorsolateral prefrontal cortices.
Group IV: Sham stimulationPlacebo Group1 Intervention
Participants receiving sham stimulation.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Vanderbilt University Medical CenterNashville, TN
Loading ...
Who Is Running the Clinical Trial?
Vanderbilt UniversityLead Sponsor
National Institutes of Health (NIH)Collaborator
References
Non-Invasive Electrical Brain Stimulation Montages for Modulation of Human Motor Function. [2018]Non-invasive electrical brain stimulation (NEBS) is used to modulate brain function and behavior, both for research and clinical purposes. In particular, NEBS can be applied transcranially either as direct current stimulation (tDCS) or alternating current stimulation (tACS). These stimulation types exert time-, dose- and in the case of tDCS polarity-specific effects on motor function and skill learning in healthy subjects. Lately, tDCS has been used to augment the therapy of motor disabilities in patients with stroke or movement disorders. This article provides a step-by-step protocol for targeting the primary motor cortex with tDCS and transcranial random noise stimulation (tRNS), a specific form of tACS using an electrical current applied randomly within a pre-defined frequency range. The setup of two different stimulation montages is explained. In both montages the emitting electrode (the anode for tDCS) is placed on the primary motor cortex of interest. For unilateral motor cortex stimulation the receiving electrode is placed on the contralateral forehead while for bilateral motor cortex stimulation the receiving electrode is placed on the opposite primary motor cortex. The advantages and disadvantages of each montage for the modulation of cortical excitability and motor function including learning are discussed, as well as safety, tolerability and blinding aspects.
Using Transcranial Direct Current Stimulation to Treat Depression in HIV-Infected Persons: The Outcomes of a Feasibility Study. [2021]Transcranial direct current stimulation (tDCS) is a novel non-invasive neuromodulatory method that influences neuronal firing rates and excitability of neuronal circuits in the brain. tDCS has been shown to relieve Major Depressive Disorder (MDD) in the general population, suggesting its potential for other vulnerable populations with high MDD prevalence.
Transcranial current brain stimulation (tCS): models and technologies. [2022]In this paper, we provide a broad overview of models and technologies pertaining to transcranial current brain stimulation (tCS), a family of related noninvasive techniques including direct current (tDCS), alternating current (tACS), and random noise current stimulation (tRNS). These techniques are based on the delivery of weak currents through the scalp (with electrode current intensity to area ratios of about 0.3-5 A/m2) at low frequencies (typically
No effect of anodal tDCS on motor cortical excitability and no evidence for responders in a large double-blind placebo-controlled trial. [2021]Transcranial direct current stimulation (tDCS) has emerged as a non-invasive brain stimulation technique. Most studies show that anodal tDCS increases cortical excitability. However, this effect has been found to be highly variable.
Beta-frequency EEG activity increased during transcranial direct current stimulation. [2014]Transcranial direct current stimulation (tDCS) is a technique for noninvasively stimulating specific cortical regions of the brain with small (
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation investigated as a treatment for several neuropsychiatric disorders. Notwithstanding tDCS-induced adverse events (AEs) are considered to be low and transient, systematic review analyses on safety and tolerability of tDCS derive mostly from single-session studies.
Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. [2023]Low intensity transcranial electrical stimulation (TES) in humans, encompassing transcranial direct current (tDCS), transcutaneous spinal Direct Current Stimulation (tsDCS), transcranial alternating current (tACS), and transcranial random noise (tRNS) stimulation or their combinations, appears to be safe. No serious adverse events (SAEs) have been reported so far in over 18,000 sessions administered to healthy subjects, neurological and psychiatric patients, as summarized here. Moderate adverse events (AEs), as defined by the necessity to intervene, are rare, and include skin burns with tDCS due to suboptimal electrode-skin contact. Very rarely mania or hypomania was induced in patients with depression (11 documented cases), yet a causal relationship is difficult to prove because of the low incidence rate and limited numbers of subjects in controlled trials. Mild AEs (MAEs) include headache and fatigue following stimulation as well as prickling and burning sensations occurring during tDCS at peak-to-baseline intensities of 1-2mA and during tACS at higher peak-to-peak intensities above 2mA. The prevalence of published AEs is different in studies specifically assessing AEs vs. those not assessing them, being higher in the former. AEs are frequently reported by individuals receiving placebo stimulation. The profile of AEs in terms of frequency, magnitude and type is comparable in healthy and clinical populations, and this is also the case for more vulnerable populations, such as children, elderly persons, or pregnant women. Combined interventions (e.g., co-application of drugs, electrophysiological measurements, neuroimaging) were not associated with further safety issues. Safety is established for low-intensity 'conventional' TES defined as <4mA, up to 60min duration per day. Animal studies and modeling evidence indicate that brain injury could occur at predicted current densities in the brain of 6.3-13A/m2 that are over an order of magnitude above those produced by tDCS in humans. Using AC stimulation fewer AEs were reported compared to DC. In specific paradigms with amplitudes of up to 10mA, frequencies in the kHz range appear to be safe. In this paper we provide structured interviews and recommend their use in future controlled studies, in particular when trying to extend the parameters applied. We also discuss recent regulatory issues, reporting practices and ethical issues. These recommendations achieved consensus in a meeting, which took place in Göttingen, Germany, on September 6-7, 2016 and were refined thereafter by email correspondence.
Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]Transcranial direct current stimulation (tDCS) is reported to induce irritating skin sensations and occasional skin injuries, which limits the applied tDCS dose. Additionally, tDCS hardware safety profile prevents high current delivery when skin resistance is high.
Safety of Transcranial Direct Current Stimulation of Frontal, Parietal, and Cerebellar Regions in Fasting Healthy Adults. [2020](1) Background: Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation modality that has been investigated in a large number of studies in terms of it is effects on brain function, safety of use, and future implications. The principal aim of this study was to investigate the safety of 1.5-mA tDCS of three brain areas, that is, frontal, partial, and cerebellar cortices, in fasting healthy individuals during the month of Ramadan. (2) Methods: In a single-blinded, sham-controlled study, we assessed the safety of a 20-min tDCS current (1.5 mA, 35 cm²) over the right frontal, parietal, and cerebellar cortex areas after 8 h of fasting in healthy right-handed adult subjects using a standard safety questionnaire. (3) Results: A total of 49 subjects completed the tDCS sessions and safety questionnaire. None of the sessions were stopped due to pain or discomfort during stimulation. Moreover, no subject experienced serious adverse events such as seizures or loss of consciousness. (4) Conclusions: There was no significant difference in the frequency or type of side effects between active and sham stimulation sessions. The tDCS protocol applied in this study was found to be safe in fasting healthy adults.
Safety of transcranial direct current stimulation in healthy participants. [2021]•Transcranial Direct Current Stimulation (tDCS) is mostly reported as safe.•BUT it could induce life-changing conditions in healthy volunteers.•Scientific community MUST be warned that tDCS may be harmful and protect healthy volunteers.
Evidence for reading improvement following tDCS treatment in children and adolescents with Dyslexia. [2018]There is evidence that non-invasive brain stimulation transitorily modulates reading by facilitating the neural pathways underactive in individuals with dyslexia. The study aimed at investigating whether multiple sessions of transcranial direct current stimulation (tDCS) would enhance reading abilities of children and adolescents with dyslexia and whether the effect is long-lasting.
tDCS Modulatory Effect on Reading Processes: A Review of Studies on Typical Readers and Individuals With Dyslexia. [2020]The possibility to use non-invasive brain stimulation to modulate reading performance in individuals with developmental dyslexia (DD) has been recently explored by few empirical investigations. The present systematic review includes nine studies which have employed transcranial direct current stimulation (tDCS) aiming at improving reading abilities in both typical readers and individuals with DD. Anodal tDCS over the left temporo-parietal cortex-a region which is typically involved in phonological and orthographic processing during reading tasks and underactive in individuals with DD-was the most frequently used montage. The majority of studies employing such stimulation protocol showed significant improvement in differential reading subprocesses. More precisely, word decoding was improved in adult readers, whereas non-word and low-frequency word reading in younger individuals. Furthermore, tDCS was found to be specifically effective in poor readers and individuals with DD rather than typical readers, in spite of the specific brain region targeted by the stimulation; Left frontal, left temporo-parietal, and right cerebellar tDCS failed to modulate reading in already proficient readers. Overall, tDCS appears to be a promising remedial tool for reading difficulties, even when applied to younger populations with reading problems. Further empirical evidence is needed to confirm the potential of neuromodulation as a successful intervention method for DD.
Long-lasting improvement following tDCS treatment combined with a training for reading in children and adolescents with dyslexia. [2020]Noninvasive brain stimulation transiently modulates reading ability in individuals with dyslexia by facilitating the underactive neural pathways in them. However, its long-term effects have not been determined. This study confirmed the ameliorative effects of multiple sessions of transcranial direct current stimulation (tDCS) combined with a training for reading on the reading abilities of children and adolescents with dyslexia and examined whether they are long-lasting. Twenty-six children and adolescents with dyslexia received 3 20-min sessions per week for 6 weeks (18 sessions) of left anodal/right cathodal tDCS, set to 1 mA, over the parieto-temporal regions, combined with training for reading. The participants were randomly assigned to receive active or sham treatment. Reading measures (text, high- and low-frequency words, non-words) were recorded before and immediately after the treatment and 1 and 6 months later. The long-term tolerability to tDCS was also evaluated. The active group received long-lasting benefits in reading. Specifically, the non-word reading efficiency index improved at every time point, as did the low-frequency word reading efficiency index at 1 and 6 months after the end of the treatment. No differences emerged in the sham group. No long-term adverse effects were documented. This study provides evidence of persistent improvements in reading in children and adolescents with dyslexia, constituting a new rehabilitative approach for the remediation of dyslexia.
The use of noninvasive brain stimulation techniques to improve reading difficulties in dyslexia: A systematic review. [2023]Noninvasive brain stimulation (NIBS) allows to actively and noninvasively modulate brain function. Aside from inhibiting specific processes, NIBS may also enhance cognitive functions, which might be used for the prevention and intervention of learning disabilities such as dyslexia. However, despite the growing interest in modulating learning abilities, a comprehensive, up-to-date review synthesizing NIBS studies with dyslexics is missing. Here, we fill this gap and elucidate the potential of NIBS as treatment option in dyslexia. The findings of the 15 included studies suggest that repeated sessions of reading training combined with different NIBS protocols may induce long-lasting improvements of reading performance in child and adult dyslexics, opening promising avenues for future research. In particular, the "classical" reading areas seem to be most successfully modulated through NIBS, and facilitatory protocols can improve various reading-related subprocesses. Moreover, we emphasize the need to further explore the potential to modulate auditory cortex function as a preintervention and intervention approach for affected children, for example, to avoid the development of auditory and phonological difficulties at the core of dyslexia. Finally, we outline how future studies may increase our understanding of the neurobiological basis of NIBS-induced improvements in dyslexia.
Reading changes in children and adolescents with dyslexia after transcranial direct current stimulation. [2016]Noninvasive brain stimulation offers the possibility to induce changes in cortical excitability and it is an interesting option as a remediation tool for the treatment of developmental disorders. This study aimed to investigate the effect of transcranial direct current stimulation (tDCS) on reading and reading-related skills of children and adolescents with dyslexia. Nineteen children and adolescents with dyslexia performed different reading and reading-related tasks (word, nonword, and text reading; lexical decision; phonemic blending; verbal working memory; rapid automatized naming) in a baseline condition without tDCS and after 20 min of exposure to three different tDCS conditions: left anodal/right cathodal tDCS to enhance left lateralization of the parietotemporal region, right anodal/left cathodal tDCS to enhance right lateralization of the parietotemporal region, and sham tDCS. In text reading, results showed a significant reduction in errors after left anodal/right cathodal tDCS and an increase in errors after left cathodal/right anodal tDCS. No effect was found in the other reading and reading-related tasks. Our findings indicate for the first time that one session of tDCS modulates some aspects of reading performance of children and adolescents with dyslexia and that the effect is polarity dependent. These single-session results support a potential role of tDCS for developing treatment protocols and suggest possible parameters for tDCS treatment customization in children and adolescents with dyslexia.