tDCS for Post-Stroke Neglect
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byEmily S. Grattan, PhD OTR MS
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Seizures, Brain tumor, Pregnancy, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This study examines how to best assess and treat post-stroke neglect. This study will examine the preliminary effects of an innovative intervention (repetitive task-specific practice + transcranial direct current stimulation) for individuals with neglect. This study will also determine whether items from various neglect assessments can be combined to establish a more comprehensive neglect measure.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment tDCS for post-stroke neglect?
Research suggests that transcranial direct current stimulation (tDCS) can help improve attention and reduce neglect in stroke patients by balancing brain activity between the two hemispheres. Studies show moderate evidence that tDCS, especially when combined with other therapies, can aid in the rehabilitation of hemispatial neglect after a stroke.
12345Is transcranial direct current stimulation (tDCS) safe for humans?
Research shows that tDCS is generally safe for humans, with no reports of serious adverse effects or permanent injury in over 33,200 sessions. Common mild side effects include itching, tingling, and headaches, but these are not significantly different from those experienced with placebo treatments.
16789How is the treatment tDCS unique for post-stroke neglect?
Transcranial Direct Current Stimulation (tDCS) is unique for post-stroke neglect as it uses a mild electrical current to modulate brain activity, aiming to restore balance between the brain's hemispheres, which can improve attention and perception. Unlike traditional therapies, tDCS is non-invasive and can be combined with standard care to enhance rehabilitation outcomes.
123510Eligibility Criteria
This trial is for individuals who had a stroke at least 3 months ago and are experiencing unilateral neglect, with specific scores on the Virtual Reality Lateralized Attention Test and Fugl-Meyer Upper Extremity assessment. They must have inducible motor responses in their thumb muscles but cannot have severe spasticity, significant language or cognitive impairments, or any conditions that pose risks to MRI, TMS, or tDCS procedures.Inclusion Criteria
Your Fugl-Meyer Upper Extremity score is between 20 and 56 out of 60.
You have a specific response in your hand muscles when stimulated.
I had a stroke more than 3 months ago.
+1 more
Exclusion Criteria
You have a severe difficulty understanding or speaking because of a stroke or other cognitive issues.
I do not have a history of seizures, brain tumors, metal implants, or am not pregnant.
I experience severe muscle stiffness.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a single session of either sham or active tDCS paired with repetitive task-specific practice
1 day
1 visit (in-person)
Assessment
Participants are assessed for changes in motor and attentional impairment using various neglect assessments
1.5 hours
1 visit (in-person)
Follow-up
Participants are monitored for any immediate post-treatment effects
30 minutes
Participant Groups
The study is testing an innovative treatment combining repetitive task-specific practice with transcranial direct current stimulation (tDCS) to improve attention deficits after a stroke. Participants will be randomly assigned to receive either active tDCS or a sham (placebo) version alongside their exercises.
2Treatment groups
Active Control
Placebo Group
Group I: Active tDCS plus RTPActive Control1 Intervention
Single session of bilateral active parietal cortex tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP)
Group II: Sham tDCS plus RTPPlacebo Group1 Intervention
Single session of bilateral sham parietal cortex tDCS (for 30 minutes) paired with repetitive task-specific practice (RTP)
Active tDCS is already approved in United Kingdom, Brazil for the following indications:
🇬🇧 Approved in United Kingdom as Transcranial Direct Current Stimulation for:
- Depression
🇧🇷 Approved in Brazil as Transcranial Direct Current Stimulation for:
- Depression
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ralph H. Johnson VA Medical Center, Charleston, SCCharleston, SC
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PAPittsburgh, PA
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Blinding in electric current stimulation in subacute neglect patients with current densities of 0.8 A/m2: a cross-over pilot study. [2021]Label="OBJECTIVE" NlmCategory="OBJECTIVE">Neglect after stroke is a disabling disorder and its rehabilitation is a major challenge. Transcranial direct current stimulation (tDCS) seems to be a promising adjuvant technique to improve standard care neglect therapy. Since electric fields are influenced by age-related factors, higher current densities are probably needed for effective treatment in aged stroke patients. Validation of treatment efficacy requires sham-controlled experiments, but increased current densities might comprise blinding. Therefore, a pilot study was conducted to test sham adequacy when using current density of 0.8 A/m2. Whether especially neglect patients who mainly suffer from perceptual and attentional deficits are able to differentiate beyond chance active from sham tDCS was investigated in a randomized cross-over design (active/sham stimulation) in 12 early subacute patients with left-sided hemineglect. Stimulation (0.8 A/m2) was performed simultaneous to standard care neglect therapy.
Transcranial direct current stimulation to the parietal cortex in hemispatial neglect: A feasibility study. [2022]Prior research suggests that dampening neural activity of the intact, presumably overactive hemisphere, combined with increasing neural activity in the damaged hemisphere, might restore cortical interhemispheric balance and reduce neglect. In the present study we repeatedly applied a relatively new technique, transcranial direct current stimulation (tDCS), to the posterior parietal cortex to modulate spontaneous neural activity levels in a polarity dependent fashion to find evidence for improvements in severe hemispatial neglect in chronic patients.
Transcranial direct current stimulation in neglect rehabilitation after stroke: a systematic review. [2022]Hemispatial neglect is one of the most frequent attention disorders after stroke. The presence of neglect is associated with longer hospital stays, extended rehabilitation periods, and poorer functional recovery. Transcranial direct current stimulation (tDCS) is a new technique with promising results in neglect rehabilitation; therefore, the objective of this systematic review, performed following the PRISMA guidelines, is to evaluate the effectiveness of tDCS on neglect recovery after stroke. The search was done in MEDLINE (PubMed), Web of Science, Scopus, Cochrane Library, and BioMed Central databases. A total of 311 articles were found; only 11 met the inclusion criteria, including 152 post-stroke patients in total. Methodological quality and risk of bias were assessed for all the studies, and methodological characteristics of the studies, sample sizes, methods, main results, and other relevant data were extracted. tDCS intervention ranged from one to twenty sessions distributed in 1 day to 4 weeks, with intensity ranged from 1 to 2 mA. We found moderate evidence for the efficacy of tDCS in the rehabilitation of hemispatial neglect after a stroke, being more effective in combination with other interventions. Nonetheless, the limited number of studies and some studies' design characteristics makes it risky to draw categorical conclusions. Since scientific evidence is still scarce, further research is needed to determine the advantage of this treatment in acute, sub-acute and chronic stroke patients. Future studies should include larger samples, longer follow-ups, and broader neurophysiological assessments, with the final aim of establishing the appropriate use of tDCS as an adjuvant intervention in neurorehabilitation settings.
Non-invasive brain stimulation in Stroke patients (NIBS): A prospective randomized open blinded end-point (PROBE) feasibility trial using transcranial direct current stimulation (tDCS) in post-stroke hemispatial neglect. [2022]Up to 80% of people who experience a right-hemisphere stroke suffer from hemispatial neglect. This syndrome is debilitating and impedes rehabilitation. We carried out a clinical feasibility trial of transcranial direct current stimulation (tDCS) and a behavioural rehabilitation programme, alone or in combination, in patients with neglect. Patients >4 weeks post right hemisphere stroke were randomized to 10 sessions of tDCS, 10 sessions of a behavioural intervention, combined intervention, or a control task. Primary outcomes were recruitment and retention rates, with secondary outcomes effect sizes on measures of neglect and quality of life, assessed directly after the interventions, and at 6 months follow up. Of 288 confirmed stroke cases referred (representing 7% of confirmed strokes), we randomized 8% (0.6% of stroke cases overall). The largest number of exclusions (91/288 (34%)) were due to medical comorbidities that prevented patients from undergoing 10 intervention sessions. We recruited 24 patients over 29 months, with 87% completing immediate post-intervention and 67% 6 month evaluations. We established poor feasibility of a clinical trial requiring repeated hospital-based tDCS within a UK hospital healthcare setting, either with or without behavioural training, over a sustained time period. Future trials should consider intensity, duration and location of tDCS neglect interventions.Trial registration: ClinicalTrials.gov identifier: NCT02401724.
Transcranial electric stimulation optimizes the balance of visual attention across space. [2020]Transcranial direct current stimulation (tDCS) provides a way to modulate spatial attention by enhancing the ratio of neural activity between the left and right hemispheres, with a potential benefit for the rehabilitation of visual neglect.
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, and limited to, the absence of evidence for a Serious Adverse Effect, the criteria for which are rigorously defined. This review adopts an evidence-based approach, based on an aggregation of experience from human trials, taking care not to confuse speculation on potential hazards or lack of data to refute such speculation with evidence for risk. Safety data from animal tests for tissue damage are reviewed with systematic consideration of translation to humans. Arbitrary safety considerations are avoided. Computational models are used to relate dose to brain exposure in humans and animals. We review relevant dose-response curves and dose metrics (e.g. current, duration, current density, charge, charge density) for meaningful safety standards. Special consideration is given to theoretically vulnerable populations including children and the elderly, subjects with mood disorders, epilepsy, stroke, implants, and home users. Evidence from relevant animal models indicates that brain injury by Direct Current Stimulation (DCS) occurs at predicted brain current densities (6.3-13 A/m(2)) that are over an order of magnitude above those produced by conventional tDCS. To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 milliamperes, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions and 1000 subjects with repeated sessions. This includes a wide variety of subjects, including persons from potentially vulnerable populations.
Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. [2023]Transcranial direct current stimulation (tDCS) has considerable potential as a useful method in the field of neurorehabilitation. However, the safety of tDCS for the human is primarily based on theoretical evidence related to electricity, and the safety information of applying tDCS to the human is only available from researcher's reporting. Based on tDCS studies with human and animal subjects and simulation-based studies of the safety of current stimulation in the past 20 years, this review investigated the safety of tDCS application to the human body. No severe complications have been reported in either adults or children for tDCS at an intensity of 4 mA or less, within a period of 60 minutes per day, using commonly applied 25 or 35 cm2 electrodes. According to animal studies, the amount of electricity used for tDCS is less than 5% of the amount that permanently changes brain tissue, thereby ensuring safety to a certain extent. In order to increase the efficacy of tDCS for neurorehabilitation and to minimize even trivial complications in the human screening of exclusion criteria should be conducted with detailed observations of complications.
A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]Transcranial direct current stimulation (tDCS) is a non-invasive method of brain stimulation that has been intensively investigated in clinical and cognitive neuroscience. Although the general impression is that tDCS is a safe technique with mild and transient adverse effects (AEs), human data on safety and tolerability are largely provided from single-session studies in healthy volunteers. In addition the frequency of AEs and its relationship with clinical variables is unknown. With the aim of assessing tDCS safety in different conditions and study designs, we performed a systematic review and meta-analysis of tDCS clinical trials. We assessed Medline and other databases and reference lists from retrieved articles, searching for articles from 1998 (first trial with contemporary tDCS parameters) to August 2010. Animal studies, review articles and studies assessing other neuromodulatory techniques were excluded. According to our eligibility criteria, 209 studies (from 172 articles) were identified. One hundred and seventeen studies (56%) mentioned AEs in the report. Of these studies, 74 (63%) reported at least one AE and only eight studies quantified AEs systematically. In the subsample reporting AEs, the most common were, for active vs. sham tDCS group, itching (39.3% vs. 32.9%, p>0.05), tingling (22.2% vs. 18.3%, p>0.05), headache (14.8% vs. 16.2%, p>0.05), burning sensation (8.7% vs. 10%, p>0.05) and discomfort (10.4% vs. 13.4%, p>0.05). Meta-analytical techniques could be applied in only eight studies for itching, but no definite results could be obtained due to between-study heterogeneity and low number of studies. Our results suggested that some AEs such as itching and tingling were more frequent in the tDCS active group, although this was not statistically significant. Although results suggest that tDCS is associated with mild AEs only, we identified a selective reporting bias for reporting, assessing and publishing AEs of tDCS that hinders further conclusions. Based on our findings, we propose a revised adverse effects questionnaire to be applied in tDCS studies in order to improve systematic reporting of tDCS-related AEs.
Translational research in transcranial direct current stimulation (tDCS): a systematic review of studies in animals. [2021]Recent therapeutic human studies testing transcranial direct current stimulation (tDCS) has shown promising results, although many questions remain unanswered. Translational research with experimental animals is an appropriate framework for investigating its mechanisms of action that are still undetermined. Nevertheless, animal and human studies are often discordant. Our aim was to review tDCS animal studies, examining and comparing their main findings with human studies. We performed a systematic review in Medline and other databases, screening for animal studies in vivo that delivered tDCS. Studies in vitro and using other neuromodulatory techniques were excluded. We extracted data according to Animal Research: Reporting In Vivo Experiments (ARRIVE) guidelines for reporting in vivo animal research. Thus, we collected data on sample characteristics (size, gender, weight and specimen) and methodology (experimental procedures, experimental animals, housing and husbandry, as well as analysis). We also collected data on methods for delivering tDCS (location, size, current and current density of electrodes and electrode montage), experimental effects (polarity-, intensity- and after-effects) and safety. Only 12 of 48 potentially eligible studies met our inclusion criteria and were reviewed. Quality assessment reporting was only moderate and studies were heterogeneous regarding tDCS montage methodology, position of active and reference electrodes, and current density used. Nonetheless, almost all studies demonstrated that tDCS had positive immediate and long-lasting effects. Vis-à-vis human trials, animal studies applied higher current densities (34.2 vs. 0.4 A/m(2), respectively), preferred extra-cephalic positions for reference electrodes (60% vs. 10%, respectively) and used electrodes with different sizes more often. Potential implications for translational tDCS research are discussed.
The Effect of Transcranial Direct Current Stimulation on Neglect Syndrome in Stroke Patients. [2020]To examine whether transcranial direct current stimulation (tDCS) applied over the posterior parietal cortex (PPC) improves visuospatial attention in stroke patients with left visuospatial neglect.