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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether a non-invasive brain stimulation technique, transcranial direct current stimulation (tDCS), combined with traditional cognitive therapy will improve cognitive function in patients with subacute stroke.

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 data supports the effectiveness of the treatment tDCS for stroke-related cognitive impairment?

Research shows that combining transcranial direct current stimulation (tDCS) with cognitive training can improve cognitive tasks in stroke survivors, although the specific added benefit of tDCS alone is not clear. Some studies suggest improvements in daily activities and cognitive functions when tDCS is used with other therapies. ^{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 serious adverse effects reported in over 33,200 sessions. Common mild side effects include itching, tingling, and headaches, which are usually temporary. ^{6 7 8 9 10}

How is the treatment tDCS + Cognitive Therapy different from other treatments for stroke-related cognitive impairment?

The treatment combines transcranial direct current stimulation (tDCS), which uses a mild electrical current to stimulate specific brain areas, with cognitive therapy to potentially enhance cognitive function in stroke patients. This approach is unique because it targets brain activity directly and is used alongside cognitive exercises, unlike traditional therapies that may focus solely on cognitive exercises or medication. ^{1 2 3 5 11}

Research Team

Kelly Sloane, MD

Principal Investigator

University of Pennsylvania

Roy Hamilton, PhD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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 am between 18 and 90 years old.

I have thinking or memory problems due to a stroke.

Exclusion Criteria

I have a history of seizures or epilepsy.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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) 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]

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 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]

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) 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) 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]

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]

References

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

The Effects of Transcranial Direct-Current Stimulation on Cognition in Stroke Patients. [2020]

2. Sweden pubmed.ncbi.nlm.nih.gov

Explore combined use of transcranial direct current stimulation and cognitive training on executive function after stroke. [2022]

3. United States 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. [2022]

4. Korea (South) 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. [2022]

5. United States 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. [2023]

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

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

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

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]

8. England 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. [2021]

9. England pubmed.ncbi.nlm.nih.gov

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

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

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

11. Netherlands 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. [2020]