tDCS for Post-Stroke Neglect

Recruiting at 1 trial location

Overseen By George F Wittenberg, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Seizures, Brain tumor, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

17 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to treat and measure recovery from post-stroke neglect, a condition where individuals struggle to pay attention to one side of their body or environment. The study tests a combination of repetitive task practice with transcranial direct current stimulation (tDCS), which uses a mild electrical current to stimulate the brain. Participants will receive either active tDCS or a sham (inactive) version to determine which is more effective. The trial seeks individuals who had a stroke over three months ago and still experience symptoms like difficulty noticing things on one side. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could improve recovery methods for post-stroke neglect.

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 prior data suggests that this intervention is safe for individuals with post-stroke neglect?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe. Studies indicate that using tDCS at levels like the 2 mA used in this trial does not cause serious side effects, and most participants tolerate it well. Some may experience mild side effects, such as tingling or itching on the scalp, but these are temporary and not harmful.

Evidence suggests that tDCS can aid recovery after a stroke, particularly when combined with other treatments. It is important to understand that while tDCS is safe, the benefits can vary among individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of transcranial Direct Current Stimulation (tDCS) for post-stroke neglect because it offers a non-invasive way to potentially improve brain function. Unlike traditional rehabilitation techniques, which often focus solely on physical or cognitive exercises, tDCS involves applying a mild electrical current to the scalp, targeting specific brain areas to enhance neural plasticity. This method, when paired with repetitive task-specific practice, could lead to faster and more effective recovery by directly stimulating the brain regions involved in attention and spatial awareness.

What evidence suggests that this trial's treatments could be effective for post-stroke neglect?

This trial will compare the effects of Active tDCS with Sham tDCS in treating post-stroke neglect. Studies have shown that transcranial direct current stimulation (tDCS) can improve symptoms in individuals with post-stroke neglect. Research indicates that combining tDCS with other therapies enhances its effectiveness in treating hemispatial neglect, a common post-stroke condition where individuals may ignore one side of their surroundings. One analysis found that tDCS positively reduced neglect symptoms. Additionally, tDCS has been found to aid activities of daily living, such as eating and dressing, although it may not enhance muscle strength or thinking skills. Overall, tDCS shows promise as part of a combined treatment approach for post-stroke neglect. ^{3 4 6 7 8}

Who Is on the Research Team?

Emily S. Grattan, PhD MS BS

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Active tDCS
• Sham tDCS

Trial Overview

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.

How Is the Trial Designed?

Group I: Active tDCS plus RTP Active Control 1 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 RTP Placebo Group 1 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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) applied over the posterior parietal cortex (PPC) showed improvements in visuospatial attention in stroke patients with left visuospatial neglect, particularly with anodal stimulation on the right PPC and cathodal stimulation on the left PPC.

While tDCS improved specific visuospatial tasks, such as the motor-free visual perception test and line bisection test, these improvements did not translate into significant enhancements in daily living activities or gait function, suggesting that while tDCS can aid in recovery from neglect symptoms, it may not fully restore functional independence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Transcranial Direct Current Stimulation on Neglect Syndrome in Stroke Patients. Yi, YG., Chun, MH., Do, KH., et al.[2020]

In a study involving five patients with severe chronic hemispatial neglect, transcranial direct current stimulation (tDCS) applied to the posterior parietal cortex did not show any significant improvement in neglect symptoms compared to a placebo.

Despite some initial performance improvements during the stimulation period, these effects were not sustained after treatment, suggesting that tDCS may not be an effective intervention for chronic hemispatial neglect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation to the parietal cortex in hemispatial neglect: A feasibility study. Smit, M., Schutter, DJ., Nijboer, TC., et al.[2022]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

A systematic review of 12 animal studies on transcranial direct current stimulation (tDCS) revealed that tDCS generally produces positive immediate and long-lasting effects, although the quality of reporting was only moderate.

Animal studies used higher current densities and different electrode placements compared to human trials, suggesting that these methodological differences could impact the translation of tDCS findings from animals to humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translational research in transcranial direct current stimulation (tDCS): a systematic review of studies in animals. Brunoni, AR., Fregni, F., Pagano, RL.[2021]

Bilateral transcranial direct current stimulation (tDCS) significantly improved visual attention in healthy individuals, enhancing detection across both visual fields without favoring one side, indicating its potential for rehabilitation in patients with visual neglect.

The stimulation showed immediate effects without a cumulative benefit over three days, suggesting that tDCS can be an effective adjunctive treatment to traditional rehabilitation methods for enhancing attention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial electric stimulation optimizes the balance of visual attention across space. Andres, M., Masson, N., Larigaldie, N., et al.[2020]

Transcranial direct current stimulation (tDCS) shows moderate evidence of effectiveness in helping recover from hemispatial neglect after a stroke, especially when combined with other rehabilitation methods, based on a systematic review of 11 studies involving 152 post-stroke patients.

Despite promising results, the limited number of studies and their varying designs mean more research is needed to confirm tDCS's benefits and establish its role in treating different stages of stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in neglect rehabilitation after stroke: a systematic review. González-Rodriguez, B., Serradell-Ribé, N., Viejo-Sobera, R., et al.[2022]

Transcranial direct current stimulation (tDCS) has been found to be safe for use in humans, with no severe complications reported in studies involving both adults and children when applied at intensities of 4 mA or less for up to 60 minutes.

Animal studies indicate that the electrical current used in tDCS is significantly lower than the threshold that could cause permanent changes to brain tissue, suggesting a strong safety profile for this neurorehabilitation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. Ko, MH.[2023]

A pilot study involving 12 early subacute stroke patients with left-sided hemineglect tested the effectiveness of transcranial direct current stimulation (tDCS) at a current density of 0.8 A/m2 during standard neglect therapy.

The results suggested that patients had a high odds ratio (10.00) for correctly identifying active tDCS versus sham stimulation, indicating potential issues with blinding that need further investigation, especially given the small sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blinding in electric current stimulation in subacute neglect patients with current densities of 0.8 A/m2: a cross-over pilot study. Gorsler, A., Grittner, U., Külzow, N., et al.[2021]

Transcranial direct current stimulation (tDCS) is generally considered safe, with mild and transient adverse effects reported in clinical trials, but the frequency and relationship of these effects with clinical variables remain unclear due to selective reporting bias.

Out of 209 studies reviewed, 117 mentioned adverse effects, with common issues like itching and tingling reported more frequently in the active tDCS group, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Brunoni, AR., Amadera, J., Berbel, B., et al.[2022]

A clinical trial involving 24 patients with hemispatial neglect after right-hemisphere stroke found that the feasibility of conducting repeated sessions of transcranial direct current stimulation (tDCS) in a hospital setting was poor, with only 8% of referred stroke cases participating.

Despite the challenges in recruitment and retention, the study highlights the need for future trials to optimize the intensity, duration, and location of tDCS interventions to improve outcomes for patients with neglect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Learmonth, G., Benwell, CSY., Märker, G., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

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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 ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0003999317305312

Noninvasive Brain Stimulation Improves Hemispatial ...

A sensitivity analysis showed that rTMS (SMD=–2.16; 95% CI, –3.00 to –1.33; I2=76%) and tDCS (SMD=–1.07; 95% CI, –1.76 to –0.37; I2=0%) had positive effects on ...

3.

cochranelibrary.com

cochranelibrary.com/cdsr/doi/10.1002/14651858.CD009645.pub4/full

Transcranial direct current stimulation (tDCS) for improving ...

This review found that tDCS might enhance ADL, but does not improve arm and leg function, muscle strength and cognitive abilities.

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e-bnr.org

e-bnr.org/DOIx.php?id=10.12786/bn.2022.15.e19

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Different transcranial direct current stimulation (tDCS) protocols have been tested to improve visuospatial neglect (VSN).

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ahajournals.org

ahajournals.org/doi/10.1161/STROKEAHA.120.033757

Transcranial Direct Current Stimulation for Activities After ...

When compared with sham, tDCS did improve ADL at the end of the intervention phase, as reported by studies presenting total values or change ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7153501/

Transcranial Direct Current Stimulation for Post-Stroke ...

In this review, we will systematically examine and discuss the hurdles and challenges in using tDCS as a brain modulation tool to enhance and facilitate ...

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thelancet.com

thelancet.com/journals/laneur/article/PIIS1474-4422(25)00044-4/abstract

Safety and efficacy of transcranial direct current stimulation ...

tDCS at doses of 2 mA or 4 mA, in addition to mCIMT, did not lead to further reduction in motor impairment in patients 1–6 months after stroke, ...

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jneuroengrehab.biomedcentral.com

jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-017-0301-7

Transcranial direct current stimulation (tDCS) for improving ...

Comparing different forms of tDCS shows that cathodal tDCS is the most promising treatment option to improve ADL capacity in people with stroke.