scholarly journals Safety and Feasibility of Transcranial Direct Current Stimulation in Pediatric Hemiparesis: Randomized Controlled Preliminary Study

2015 ◽  
Vol 95 (3) ◽  
pp. 337-349 ◽  
Author(s):  
Bernadette T. Gillick ◽  
Tim Feyma ◽  
Jeremiah Menk ◽  
Michelle Usset ◽  
Amy Vaith ◽  
...  
Keyword(s):  
Adverse Events ◽  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Hand Function ◽  
Behavioral Data ◽  
Control Group ◽  
Double Blind ◽  
Direct Current Stimulation ◽  
Preliminary Study

Background Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that has shown improved adult stroke outcomes. Applying tDCS in children with congenital hemiparesis has not yet been explored. Objective The primary objective of this study was to explore the safety and feasibility of single-session tDCS through an adverse events profile and symptom assessment within a double-blind, randomized placebo-controlled preliminary study in children with congenital hemiparesis. A secondary objective was to assess the stability of hand and cognitive function. Design A double-blind, randomized placebo-controlled pretest/posttest/follow-up study was conducted. Setting The study was conducted in a university pediatric research laboratory. Participants Thirteen children, ages 7 to 18 years, with congenital hemiparesis participated. Measurements Adverse events/safety assessment and hand function were measured. Intervention Participants were randomly assigned to either an intervention group or a control group, with safety and functional assessments at pretest, at posttest on the same day, and at a 1-week follow-up session. An intervention of 10 minutes of 0.7 mA tDCS was applied to bilateral primary motor cortices. The tDCS intervention was considered safe if there was no individual decline of 25% or group decline of 2 standard deviations for motor evoked potentials (MEPs) and behavioral data and no report of adverse events. Results No major adverse events were found, including no seizures. Two participants did not complete the study due to lack of MEP and discomfort. For the 11 participants who completed the study, group differences in MEPs and behavioral data did not exceed 2 standard deviations in those who received the tDCS (n=5) and those in the control group (n=6). The study was completed without the need for stopping per medical monitor and biostatisticial analysis. Limitations A limitation of the study was the small sample size, with data available for 11 participants. Conclusions Based on the results of this study, tDCS appears to be safe, feasible, and well tolerated in most children with hemiparesis. Future investigations of serial sessions of tDCS in conjunction with rehabilitation in pediatric hemiparesis are indicated to explore the benefit of a synergistic approach to improving hand function.

Augmentative transcranial direct current stimulation (tDCS) in poor responder depressed patients: a follow-up study

CNS Spectrums ◽  
2013 ◽  
Vol 19 (4) ◽  
pp. 347-354 ◽  
Author(s):  
Bernardo Dell'Osso ◽  
Cristina Dobrea ◽  
Chiara Arici ◽  
Beatrice Benatti ◽  
Roberta Ferrucci ◽  
...  
Keyword(s):  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Repeated Measures ◽  
Rating Scale ◽  
Drop Out ◽  
Young Mania ◽  
Double Blind ◽  
Direct Current Stimulation ◽  
Follow Up Study

ObjectivesTranscranial direct current stimulation (tDCS) is a non-invasive neurostimulation technique that has received increasing interest in the area of mood disorders over the last several years. While acute, double-blind, sham-controlled studies have already reported positive findings in terms of efficacy and safety for tDCS, follow-up data are lacking. This need prompted the present follow-up study, which assesses post-acute effects of tDCS (no maintenance stimulation was performed), in the mid-term, in a sample of major depressives.MethodsAfter completing an acute, open trial of tDCS, 23 outpatients with either major depressive disorder or bipolar disorder entered a naturalistic follow-up (T1) with clinical evaluations at one week (T2), 1 month (T3), and 3 months (T4). A quantitative analysis of Hamilton Depression Rating Scale (HAM-D), Montgomery–Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS) total scores, through repeated measures analysis of variance (ANOVA) (T1–T4) and paired t-test for comparing specific time points (T1–T2, T2–T3, and T3–T4), was performed. In addition, a qualitative analysis on the basis of treatment response and remission (HAM-D) was performed.ResultsEven though a progressive reduction of follow-up completers was observed from T2 to T4 (95.6% at T2, 65.2% at T3, and 47.8% at T4), the antidepressant effects of acute tDCS persisted over 3 months in almost half of the sample. Of note, no post-acute side effects emerged during the follow-up observation. The most frequent causes of drop-out from this study included major modifications in therapeutic regimen (30%) and poor adherence to follow-up visits (17%).ConclusionsIn this mid-term, open, follow-up study, tDCS showed mixed results. Further controlled studies are urgently needed to assess its effects beyond the acute phase.

scholarly journals Transcranial Direct Current Stimulation and Mirror Therapy for Neuropathic Pain After Brachial Plexus Avulsion: A Randomized, Double-Blind, Controlled Pilot Study

2020 ◽  
Vol 11 ◽  
Author(s):  
Clarice Martins Ferreira ◽  
Carolina Dias de Carvalho ◽  
Ruth Gomes ◽  
Erickson Duarte Bonifácio de Assis ◽  
Suellen Marinho Andrade
Keyword(s):  
Neuropathic Pain ◽  
Pain Relief ◽  
Brachial Plexus ◽  
Outcome Measures ◽  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Mirror Therapy ◽  
Double Blind ◽  
Direct Current Stimulation

Introduction: Although transcranial direct current stimulation (tDCS) and mirror therapy (MT) have benefits in combating chronic pain, there is still no evidence of the effects of the simultaneous application of these techniques in patients with neuropathic pain. This study aims to assess the efficacy of tDCS paired with MT in neuropathic pain after brachial plexus injury.Methods: In a sham controlled, double-blind, parallel-group design, 16 patients were randomized to receive active or sham tDCS administered during mirror therapy. Each patient received 12 treatment sessions, 30 min each, during a period of 4 weeks over M1 contralateral to the side of the injury. Outcome variables were evaluated at baseline and post-treatment using the McGill questionnaire, Brief Pain Inventory, and Medical Outcomes Study 36–Item Short-Form Health Survey. Long-term effects of treatment were evaluated at a 3-month follow-up.Results: An improvement in pain relief and quality of life were observed in both groups (p ≤ 0.05). However, active tDCS and mirror therapy resulted in greater improvements after the endpoint (p ≤ 0.02). No statistically significant differences in the outcome measures were identified among the groups at follow-up (p ≥ 0.12). A significant relationship was found between baseline pain intensity and outcome measures (p ≤ 0.04). Moreover, the results showed that state anxiety is closely linked to post-treatment pain relief (p ≤ 0.05).Conclusion: Active tDCS combined with mirror therapy has a short-term effect of pain relief, however, levels of pain and anxiety at the baseline should be considered.Clinical Trial Registration:www.ClinicalTrials.gov, identifier NCT04385030.

scholarly journals A RANDOMIZED CONTROLLED TRIAL ON EFFECT OF TRANSCRANIAL DIRECT CURRENT STIMULATION AND COGNITIVE BEHAVIOURAL THERAPY ON HEADACHE RELATED DISABILITY AND IMPACT OF HEADACHE ON LIFE OF MIGRAINEURS

2017 ◽  
Vol 16 (4) ◽  
pp. 141-148
Author(s):  
Manoj Malik ◽  
◽  
Shailendra Kumar Singh ◽  
Narkeesh Arumugam ◽  
◽  
...  
Keyword(s):  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Public Health Problem ◽  
Control Group ◽  
Post Intervention ◽  
Pharmacological Management ◽  
Direct Current Stimulation

Introduction. Migraine is a public health problem of great impact on patients as well as society. Migraine prophylaxis requires daily administration of anti-migraine compounds whether or not migraine attack is occurring. All the drugs used for migraine prevention have potential and often relevant adverse effect or contraindications. The purpose of present study was to evaluate efficacy of non-pharmacological management techniques like Cognitive Behavioral Therapy (CBT) and Transcranial Direct Current Stimulation (TDCS) on headache related disability and impact of headaches on life of patients suffering from migraine. Methodology. Sixty six subjects fulfilling the selection criteria were recruited for the study. They were randomly allocated into three groups. Group one received TDCS, Group 2 received CBT, and Group 3 (Control group) did not receive any treatment. Participants were asked to fi ll HDI and HIT 6 prior to start of intervention, post intervention and at follow up. Collected data was analyzed for statistical significance. Results. We found a significant decrease in HDI and HIT 6 scores in TDCS and CBT Group as compared to Control Group. This improvement was maintained during follow up period. Conclusion. TDCS and CBT can be effective in decreasing headache related disability and impact of headache on daily life in patients suffering from Migraine.

scholarly journals Delayed Auditory Feedback and Transcranial Direct Current Stimulation Treatment for the Enhancement of Speech Fluency in Adults Who Stutter: Protocol for a Randomized Controlled Trial

10.2196/16646 ◽  
2020 ◽  
Vol 9 (4) ◽  
pp. e16646
Author(s):  
Narges Moein ◽  
Reyhane Mohamadi ◽  
Reza Rostami ◽  
Michael Nitsche ◽  
Reza Zomorrodi ◽  
...  
Keyword(s):  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Auditory Feedback ◽  
Intervention Group ◽  
Control Group ◽  
Delayed Auditory Feedback ◽  
Direct Current Stimulation ◽  
Speech Fluency ◽  
Adults Who Stutter

Background Stuttering is a complex speech disorder that affects speech fluency. Recently, it has been shown that noninvasive brain stimulation may be useful to enhance the results of fluency interventions in adults who stutter. Delayed auditory feedback (DAF) is a method to enhance speech fluency in individuals who stutter. Adjunctive interventions are warranted to enhance the efficacy of this intervention. Objective Individuals who stutter have pathological activation patterns in the primary and secondary auditory areas. Consequently, in this study, we hypothesize that stimulation of these areas might be promising as an adjunctive method to fluency training via DAF to enhance speech therapy success in individuals with a stutter. We will systematically test this hypothesis in this study. Methods This study is designed as a randomized, double-blind, sham-controlled clinical trial. All participants will receive DAF. The intervention group will additionally receive real transcranial direct current stimulation, while the control group will be exposed to sham stimulation. The assignment of the participants to one of these groups will be randomized. Before starting the treatment program, 2 preintervention assessments will be conducted to determine the severity of stuttering. Once these assessments are completed, each subject will participate in 6 intervention sessions. Postintervention assessments will be carried out immediately and 1 week after the last intervention session. Subsequently, to explore the long-term stability of the treatment results, the outcome parameters will be obtained in follow-up assessments 6 weeks after the treatment. The primary outcome measurement—the percentage of stuttered syllables—will be calculated in pre-, post-, and follow-up assessments; the secondary outcomes will be the scores of the following questionnaires: the Stuttering Severity Instrument–Fourth Edition and the Overall Assessment of the Speaker’s Experience of Stuttering. Results This protocol was funded in 2019 and approved by the Research Ethics Committee of the Iran University of Medical Sciences in June 2019. Data collection started in October 2019. As of February 2020, we have enrolled 30 participants. We expect data analysis to be completed in April 2020, and results will be published in summer 2020. Conclusions We anticipate that this study will show an adjunctive effect of transcranial direct current stimulation, when combined with DAF, on stuttering. This should include not only a reduction in the percentage of stuttered syllables but also improved physical behavior and quality of life in adults who stutter. Trial Registration ClinicalTrial.gov NCT03990168; https://clinicaltrials.gov/ct2/show/NCT03990168 International Registered Report Identifier (IRRID) DERR1-10.2196/16646

scholarly journals Repeated sessions of bilateral transcranial direct current stimulation on intractable tinnitus: a study protocol for a double-blind randomized controlled trial

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 317 ◽  
Author(s):  
Arash Bayat ◽  
Miguel Mayo ◽  
Samaneh Rashidi ◽  
Nader Saki ◽  
Ali Yadollahpour
Keyword(s):  
Clinical Trial ◽  
Treatment Response ◽  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Controlled Trial ◽  
Chronic Tinnitus ◽  
Post Intervention ◽  
Double Blind ◽  
Direct Current Stimulation

Background: Transcranial Direct Current Stimulation (tDCS) is reportedly a potential treatment option for chronic tinnitus. The main drawbacks of previous studies are short term follow up and focusing on the efficacy of single session tDCS. This study aims to investigate the therapeutic efficacy, adverse effects (AEs) and tolerability of repeated sessions of bilateral tDCS over auditory cortex (AC) on tinnitus symptoms Methods: This will be a double-blinded randomized placebo controlled parallel trial on patients (n=90) with intractable chronic tinnitus (> 2 years) randomly divided into three groups of anodal, cathodal, and sham tDCS. In the sham treatment, after 30 sec the device will be turned OFF without informing the patients. The tDCS protocol consists of 10 sessions (daily  20 min session; 2 mA current for 5 consecutive days per week and 2 consecutive weeks) applied through 35 cm2 electrodes. The primary outcome is tinnitus handicap inventory (THI) which will be assessed pre- and post-intervention and at one month follow-up. The secondary outcomes are tinnitus loudness and distress to be assessed using a visual analogue scale (VAS) pre-intervention, and immediately, one hour, one week, and one month after last stimulation. The AEs and tolerability of patients will be evaluated after each session using a customized questionnaire. Possible interactions between the disease features and treatment response will be evaluated.   Discussion: To our knowledge this is the first study to investigate the effects of repeated sessions of tDCS on chronic tinnitus symptoms with one month follow-up. In addition, the AEs, and tolerability of patients will be studied. In addition, the possible interactions between the disease specific features including the hearing loss, laterality, type of tinnitus, and treatment response will be evaluated.   Trial registration: The study has been registered as a clinical trial in Iranian Registry of Clinical Trial (IRCT2016110124635N6) on the 01/06/2017.

scholarly journals Effects of Transcranial Direct Current Stimulation Treatment for Anorexia Nervosa

2021 ◽  
Vol 12 ◽  
Author(s):  
Silvie Baumann ◽  
Tadeáš Mareš ◽  
Jakub Albrecht ◽  
Martin Anders ◽  
Kristýna Vochosková ◽  
...  
Keyword(s):  
Anorexia Nervosa ◽  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Controlled Trial ◽  
Depression Scale ◽  
Calorie Intake ◽  
Double Blind ◽  
Direct Current Stimulation ◽  
Left Dlpfc

Background: Anorexia nervosa (AN) is a life-threatening illness with poor treatment outcomes. Although transcranial direct current stimulation (tDCS) is a promising non-invasive brain stimulation method, its effect in patients with AN remains unclear.Objective: This study investigated changes in maladaptive eating behavior, body mass index (BMI), and depression after 10 sessions of anodal tDCS over the left dorsolateral prefrontal cortex (DLPFC).Methods: In this double-blind, randomized controlled trial, 43 inpatients with AN were divided to receive either active (n = 22) or sham (n = 21) tDCS over the left DLPFC (anode F3/cathode Fp2, 2 mA for 30 min). All patients filled the Eating Disorder Examination Questionnaire (EDE-Q) and Zung Self-Rating Depression Scale (ZUNG), and their BMI was measured. These values were obtained repeatedly in four stages: (1) before tDCS treatment, (2) after tDCS treatment, (3) in the follow-up after 2 weeks, and (4) in the follow-up after 4 weeks.Results: Primary outcomes (EDE-Q) based on the ANOVA results do not show any between-group differences either after the active part of the study or in the follow-up. Secondary analysis reveals a reduction in some items of EDE-Q. Compared with sham tDCS, active tDCS significantly improved self-evaluation based on body shape (p < 0.05) and significantly decreased the need of excessive control over calorie intake (p < 0.05) in the 4-week follow-up. However, the results do not survive multiple comparison correction. In both sham and active groups, the BMI values improved, albeit not significantly.Conclusion: We did not observe a significant effect of tDCS over the left DLPFC on complex psychopathology and weight recovery in patients with AN. tDCS reduced the need to follow specific dietary rules and improved body image evaluation in patients with AN. Tests with a larger sample and different positions of electrodes are needed.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT03273205.

scholarly journals Surface EEG-Transcranial Direct Current Stimulation (tDCS) Closed-Loop System

2017 ◽  
Vol 27 (06) ◽  
pp. 1750026 ◽  
Author(s):  
Jorge Leite ◽  
Leon Morales-Quezada ◽  
Sandra Carvalho ◽  
Aurore Thibaut ◽  
Deniz Doruk ◽  
...  
Keyword(s):  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Closed Loop ◽  
Loop System ◽  
Alpha Power ◽  
Closed Loop System ◽  
Double Blind ◽  
Direct Current Stimulation ◽  
Beta Power ◽  
Preliminary Study

Conventional transcranial direct current stimulation (tDCS) protocols rely on applying electrical current at a fixed intensity and duration without using surrogate markers to direct the interventions. This has led to some mixed results; especially because tDCS induced effects may vary depending on the ongoing level of brain activity. Therefore, the objective of this preliminary study was to assess the feasibility of an EEG-triggered tDCS system based on EEG online analysis of its frequency bands. Six healthy volunteers were randomized to participate in a double-blind sham-controlled crossover design to receive a single session of 10[Formula: see text]min 2[Formula: see text]mA cathodal and sham tDCS. tDCS trigger controller was based upon an algorithm designed to detect an increase in the relative beta power of more than 200%, accompanied by a decrease of 50% or more in the relative alpha power, based on baseline EEG recordings. EEG-tDCS closed-loop-system was able to detect the predefined EEG magnitude deviation and successfully triggered the stimulation in all participants. This preliminary study represents a proof-of-concept for the development of an EEG-tDCS closed-loop system in humans. We discuss and review here different methods of closed loop system that can be considered and potential clinical applications of such system.

scholarly journals Connectivity as a Predictor of Responsiveness to Transcranial Direct Current Stimulation in People with Stroke: Protocol for a Double-Blind Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Ellana Welsby ◽  
Michael Ridding ◽  
Susan Hillier ◽  
Brenton Hordacre
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Controlled Trial ◽  
Double Blind ◽  
Direct Current Stimulation ◽  
Randomized Controlled ◽  
Upper Limb Function

BACKGROUND Stroke can have devastating consequences for an individual’s quality of life. Interventions capable of enhancing response to therapy would be highly valuable to the field of neurological rehabilitation. One approach is to use noninvasive brain stimulation techniques, such as transcranial direct current stimulation, to induce a neuroplastic response. When delivered in combination with rehabilitation exercises, there is some evidence that transcranial direct current stimulation is beneficial. However, responses to stimulation are highly variable. Therefore biomarkers predictive of response to stimulation would be valuable to help select appropriate people for this potentially beneficial treatment. OBJECTIVE The objective of this study is to investigate connectivity of the stimulation target, the ipsilesional motor cortex, as a biomarker predictive of response to anodal transcranial direct current stimulation in people with stroke. METHODS This study is a double blind, randomized controlled trial (RCT), with two parallel groups. A total of 68 participants with first ever ischemic stroke with motor impairment will undertake a two week (14 session) treatment for upper limb function (Graded Repetitive Arm Supplementary Program; GRASP). Participants will be randomized 2:1 to active:sham treatment groups. Those in the active treatment group will receive anodal transcranial direct current stimulation to the ipsilesional motor cortex at the start of each GRASP session. Those allocated to the sham treatment group will receive sham transcranial direct current stimulation. Behavioural assessments of upper limb function will be performed at baseline, post treatment, 1 month follow-up and 3 months follow-up. Neurophysiological assessments will include magnetic resonance imaging (MRI), electroencephalography (EEG) and transcranial magnetic stimulation (TMS) and will be performed at baseline, post treatment, 1 month follow-up (EEG and TMS only) and 3 months follow-up (EEG and TMS only). RESULTS Participants will be recruited between March 2018 and December 2018, with experimental testing concluding in March 2019. CONCLUSIONS Identifying a biomarker predictive of response to transcranial direct current stimulation would greatly assist clinical utility of this novel treatment approach. CLINICALTRIAL Australia New Zealand Clinical Trials Registry ACTRN12618000443291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618000443291 (Archived by WebCite at http://www.webcitation.org/737QOXXxt) REGISTERED REPORT IDENTIFIER RR1-10.2196/10848

scholarly journals https://jpcp.uswr.ac.ir/article-1-747-en.html

2021 ◽  
Vol 9 (3) ◽  
pp. 227-236
Author(s):  
Nastaran Mohajeri Aval ◽  
Keyword(s):  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Control Group ◽  
Direct Current Stimulation ◽  
School Aged Children ◽  
Smooth Flow ◽  
Before And After ◽  
Developmental Stuttering ◽  
Experimental Group

Objective: Stuttering is a neurodevelopmental condition affecting 5% of children. Developmental stuttering disrupts the smooth flow of speech, resulting in characteristic speech disfluencies. Anxiety is one of the most widely observed and extensively studied psychological concomitants of stuttering. Recently, it has been shown that noninvasive brain stimulation may be useful in enhancing the results of fluency interventions in people who stutter. The present study aimed to examine whether the severity of stuttering and anxiety was affected by transcranial direct current stimulation in children who stutter. Methods: This study is a clinical trial study in which the statistical community includes school-aged children in Tehran who were referred to psychological clinics for treatment. Twenty-two children with stuttering were randomly assigned in two groups. Eleven children in the experimental group would receive real transcranial direct current stimulation, and 11 children in the control group were exposed to sham stimulation. The experimental group received 20 min of 2-mA anodal stimulation in 15 sessions in three weeks. The severity of stuttering and anxiety was assessed before and after the last session and then 1 and 6 weeks after the intervention. Results: The severity of stuttering and anxiety in both groups were similar before the intervention (P>0.05). A significant decrease in the severity of stuttering and anxiety at the end of the intervention and 1 and 6 weeks after the intervention occurred in the experimental group (P<0.05), while the control group did not show any significant change. Conclusion: The results indicated that stuttering severity and anxiety were ameliorated by transcranial direct current stimulation immediately after the intervention and at 1 and 6 weeks follow-up.

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