tDCS for Post-Stroke Neglect

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Emily S. Grattan, PhD MS BS

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. ^{1 2 3 4 5}

Is 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. ^{1 6 7 8 9}

How 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. ^{1 2 3 5 10}

Research Team

Emily S. Grattan, PhD MS BS

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Eligibility 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.

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.

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

Treatment Details

Interventions

• Active tDCS (Transcranial Direct Current Stimulation)
• Sham tDCS (Transcranial Direct Current Stimulation)

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.

Participant Groups

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 Brazil for the following indications:

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+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

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]

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]

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]

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) 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]

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]

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]

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]

References

1. England 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation to the parietal cortex in hemispatial neglect: A feasibility study. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in neglect rehabilitation after stroke: a systematic review. [2022]

4. England 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. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Transcranial electric stimulation optimizes the balance of visual attention across space. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Translational research in transcranial direct current stimulation (tDCS): a systematic review of studies in animals. [2021]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

The Effect of Transcranial Direct Current Stimulation on Neglect Syndrome in Stroke Patients. [2020]