tDCS + Cognitive Therapy for Stroke-related Cognitive Impairment

(TRAINS Trial)

Recruiting at 1 trial location

Overseen By Kelli Williams, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Neurologic illness, Seizures, Alcohol abuse, others

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

Compensation: Varies

Number of Visits: 8

Duration: 1 week

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a non-invasive brain stimulation method called transcranial direct current stimulation (tDCS), combined with cognitive therapy, can improve thinking skills in individuals who have recently experienced a stroke. Participants will receive either the actual tDCS treatment or a sham (fake) version while engaging in cognitive exercises. The goal is to determine if this combination can enhance the recovery of cognitive function, often affected after a stroke. This trial may suit those who had a stroke within the last four weeks and are experiencing memory or thinking problems. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance stroke recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technique is safe for stroke-related cognitive impairment?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe for people. In a review of studies on stroke patients, only about 12% reported any side effects. The most common side effect was mild itching, occurring in 70% of those cases. Other effects, such as a burning sensation, were less common.

One study confirmed that tDCS is safe and useful for addressing cognitive problems after a stroke. As a non-invasive treatment, tDCS does not involve surgery or entering the body, making it a less risky option.

Overall, tDCS combined with cognitive therapy appears promising for improving brain function after a stroke, with few and mostly mild side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about tDCS with cognitive therapy for stroke-related cognitive impairment because it offers a non-invasive approach that could enhance brain function. Unlike traditional therapies that primarily focus on rehabilitative exercises, tDCS uses a gentle electrical current to stimulate the brain, specifically targeting the dorsolateral prefrontal cortex. This method has the potential to accelerate cognitive improvements by directly influencing neural activity, making it a promising complement to existing therapies. Additionally, the combination of tDCS with cognitive therapy may provide a synergistic effect, enhancing the overall treatment outcome.

What evidence suggests that tDCS combined with cognitive therapy is effective for stroke-related cognitive impairment?

Research has shown that transcranial direct current stimulation (tDCS) can enhance thinking and memory in individuals struggling with these skills after a stroke. Studies have found that applying tDCS to specific brain areas can boost memory and other cognitive abilities. In this trial, participants will receive either active tDCS combined with cognitive therapy or a sham tDCS combined with cognitive therapy. Previous research has demonstrated that tDCS, when paired with cognitive therapy, significantly improves thinking skills and daily activities for stroke patients. As a non-invasive treatment, tDCS does not involve surgery or entering the body and is generally considered safe. These findings suggest that combining tDCS with cognitive therapy could be a promising approach to addressing cognitive problems after a stroke. ^{2 3 6 7 8}

Who Is on the Research Team?

Kelly Sloane, MD

Principal Investigator

University of Pennsylvania

Roy Hamilton, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-90 who've had a stroke within the last 4 weeks and are now experiencing cognitive issues because of it. They must understand the study, follow simple commands, and not have serious neurological conditions (other than stroke), seizures, substance abuse problems, severe psychiatric disorders, unstable medical illnesses or metallic objects in their head.

Inclusion Criteria

I can understand and follow simple instructions.

I have thinking or memory problems due to a stroke.

I understand the study and can agree to participate.

Exclusion Criteria

I have a history of seizures or epilepsy.

You are currently misusing alcohol or drugs, whether they are prescribed to you or not.

I have a serious or unstable neurological condition, but not a stroke.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5 daily sessions of transcranial direct current stimulation (tDCS) paired with cognitive therapy

1 week

5 visits (in-person)

Follow-up

Participants are monitored for changes in cognitive performance after treatment

24 months

3 visits (in-person) at 3, 12, and 24 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• tDCS

Trial Overview

The study tests if brain stimulation with tDCS alongside traditional cognitive therapy can help improve thinking skills after a recent stroke. Participants will receive either real tDCS or a sham (fake) treatment to compare outcomes.

How Is the Trial Designed?

Group I: Transcranial Direct Current Stimulation (tDCS) + cognitive therapy Active Control 2 Interventions

Participants will undergo 5 daily sessions of tDCS for 20 minutes using a montage in which an anode (2 mA) is placed over left dorsolateral prefrontal cortex and the cathode will be place on the right supraorbital area. Subjects will participate in cognitive therapy during stimulation.

Group II: Sham Transcranial Direct Current Stimulation (tDCS) + cognitive therapy Placebo Group 2 Interventions

Participants will undergo 5 daily sessions of sham tDCS for 20 minutes using a montage in which an anode (2 mA) is placed over left dorsolateral prefrontal cortex and the cathode will be place on the right supraorbital area. Subjects will participate in cognitive therapy during stimulation.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

In a study of 45 stroke patients with cognitive dysfunction, anodal transcranial direct-current stimulation (tDCS) applied to the left anterior temporal lobe significantly improved verbal learning abilities compared to sham stimulation.

Despite improvements in verbal learning, there were no significant changes in overall cognitive function or daily living activities as measured by the K-MMSE and K-MBI, suggesting that tDCS may specifically enhance certain cognitive aspects rather than overall cognitive performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Transcranial Direct-Current Stimulation on Cognition in Stroke Patients. Yun, GJ., Chun, MH., Kim, BR.[2020]

A systematic review of 64 studies involving 2262 participants found that transcranial direct current stimulation (tDCS) has a low dropout rate (6% for active and 7.2% for sham), indicating good acceptability among participants.

Despite the low dropout rates, many studies inadequately reported adverse events (AEs), highlighting a need for improved guidelines to standardize AE reporting in tDCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. Aparício, LVM., Guarienti, F., Razza, LB., et al.[2018]

In a study involving 77 chronic stroke patients, combining computerized cognitive training (CCT) with transcranial direct current stimulation (tDCS) led to significant improvements in cognitive performance, but tDCS did not provide any additional benefits over CCT alone.

fMRI results indicated that improved cognitive performance was linked to increased brain activation in areas associated with attention, but there was no clear relationship between initial brain activation levels and cognitive gains, suggesting that the training itself was effective regardless of tDCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability, sensitivity, and predictive value of fMRI during multiple object tracking as a marker of cognitive training gain in combination with tDCS in stroke survivors. Kolskår, KK., Richard, G., Alnaes, D., et al.[2022]

Anodal transcranial direct current stimulation (tDCS) significantly improved cognitive performance in healthy elderly individuals by increasing neural activity, as evidenced by enhanced P200 and P300 amplitudes during a working memory task.

Cathodal tDCS also showed potential benefits for Alzheimer's disease patients, increasing P200 amplitude and frontal theta activity, suggesting that tDCS can modulate neural function differently based on the individual's cognitive state.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural and electrophysiological modulations induced by transcranial direct current stimulation in healthy elderly and Alzheimer's disease patients: A pilot study. Cespón, J., Rodella, C., Miniussi, C., et al.[2020]

Transcranial direct current stimulation (tDCS) combined with cognitive training significantly improved executive function and performance in daily activities among 50 stroke patients, as measured by various cognitive tests.

While most cognitive assessments showed significant improvements in the tDCS group compared to the sham group, some specific tasks related to daily living did not show notable differences, indicating that tDCS may be more effective for certain cognitive functions than others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Explore combined use of transcranial direct current stimulation and cognitive training on executive function after stroke. Liu, YW., Chen, ZH., Luo, J., et al.[2022]

This study will evaluate the safety and efficacy of transcranial direct current stimulation (tDCS) combined with cognitive tasks in patients with neurocognitive disorders, using a randomized controlled trial design with 92 participants (46 per group).

The primary outcome will be measured by changes in cognitive function using the Alzheimer Disease Assessment Scale, with additional assessments for depressive symptoms and quality of life, providing a comprehensive evaluation of tDCS effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of multisession transcranial direct current stimulation as an augmentation to cognitive tasks in patients with neurocognitive disorders in Japan: a study protocol for a randomised controlled trial. Inagawa, T., Yokoi, Y., Yamada, Y., et al.[2021]

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]

In a study involving 11 newly diagnosed stroke patients, the combination of transcranial direct current stimulation (tDCS) and computer-assisted cognitive rehabilitation (CACR) significantly improved cognitive function compared to a control group receiving sham stimulation.

Patients receiving tDCS showed notable enhancements in auditory and visual continuous performance tests, suggesting that targeting the prefrontal cortex with tDCS alongside cognitive training can effectively aid recovery from cognitive dysfunction after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, sham-controlled, pilot study to assess the effects of the concomitant use of transcranial direct current stimulation with the computer assisted cognitive rehabilitation to the prefrontal cortex on cognitive functions in patients with stroke. Park, SH., Koh, EJ., Choi, HY., et al.[2022]

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) significantly improves cognitive function and daily living activities in patients with poststroke cognitive impairment, based on a meta-analysis of 22 studies involving 1198 participants.

The treatment was associated with enhanced scores on various cognitive assessments and improved daily activity performance, indicating its potential as an effective rehabilitation tool for cognitive recovery after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation for Global Cognitive Functioning and Ability in Daily Life Activities in Poststroke Cognitive Impairment: A Systematic Review and Meta-analysis. Lyu, Z., Liu, F., Xiu, H., et al.[2023]

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