tDCS for Cognitive Impairment After Stroke

Overseen By Cheryl Adams, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Oklahoma

Disqualifiers: Severe depression, Epilepsy, Dementia, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 13

Duration: 2 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the effects of a form of non-invasive brain stimulation on brain functioning and memory in participants with post-stroke cognitive impairment (PSCI).

Do I need to stop my current medications for the trial?

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 Transcranial Direct Current Stimulation (tDCS) for cognitive impairment after stroke?

Research shows that tDCS, when combined with cognitive training, can improve cognitive tasks in stroke survivors, although the additional benefit of tDCS alone is unclear. Some studies suggest it might help with daily activities and cognitive functions, but more evidence is needed to confirm its effectiveness. ^{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 across various populations, including those with stroke. Some mild side effects like tingling or itching may occur, but they are usually temporary. ^{6 7 8 9 10}

How does the treatment tDCS differ from other treatments for cognitive impairment after stroke?

Transcranial Direct Current Stimulation (tDCS) is unique because it involves applying a low electrical current to the scalp to potentially improve brain function, unlike traditional treatments that might rely on medication or physical therapy. It is non-invasive and can be combined with cognitive training to target specific brain areas, such as the prefrontal cortex, which may help enhance cognitive abilities in stroke patients. ^{1 2 3 5 11}

Eligibility Criteria

This trial is for individuals who have experienced a stroke and are now dealing with cognitive impairments, specifically issues with memory. The details of the inclusion and exclusion criteria were not provided.

Inclusion Criteria

I had a stroke between 10 days and 5 months ago and have trouble with thinking or memory.

Exclusion Criteria

I have had brain surgery where part of my skull was removed.

I do not have any serious or unstable health or mental conditions.

I have been diagnosed with severe depression.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active or sham tDCS for 20 minutes, for 10 sessions

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for changes in cognitive function, blood markers, and brain activity

3 months

3 visits (in-person)

Treatment Details

Interventions

• Transcranial Direct Current Stimulation

Trial Overview The study is testing Transcranial Direct Current Stimulation (tDCS), which is a non-invasive brain stimulation technique, to see if it can improve brain function and memory in people with post-stroke cognitive impairment.

Participant Groups

Group I: active tDCS Experimental Treatment 1 Intervention

Participants will receive active tDCS for 20 minutes, for 10 sessions

Group II: sham tDCS Placebo Group 1 Intervention

Participants will receive sham (placebo) tDCS for 20 minutes, for 10 sessions

Transcranial Direct Current Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as Transcranial Direct Current Stimulation for:

• Chronic pain management
• Depression
• Anxiety

Approved in European Union as Transcranial Direct Current Stimulation for:

• Chronic pain management
• Neurological rehabilitation

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

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]

Transcranial direct current stimulation (tDCS) shows some potential in improving activities of daily living (ADLs) in stroke survivors, with a moderate effect size observed in a systematic review of 32 studies involving 748 participants.

However, the evidence for tDCS's effectiveness on upper extremity function and muscle strength is weak, and many ongoing trials may provide more clarity on its benefits in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Elsner, B., Kugler, J., Pohl, M., et al.[2023]

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]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., 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]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

Transcranial direct current stimulation (tDCS) was found to be feasible and safe for use in outpatient therapy for stroke patients, with 100% adherence among the 7 participants who completed the study over 5-6 weeks.

Most participants (71%) reported positive impressions of tDCS, experiencing acute improvements in function and energy, with only one adverse event unrelated to the treatment and mild side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Transcranial Direct Current Stimulation in an Outpatient Rehabilitation Setting After Stroke. Cleland, BT., Galick, M., Huckstep, A., et al.[2020]

Anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex significantly improved working memory performance in stroke patients, as shown by increased recognition accuracy after stimulation.

In a study involving 10 patients with cognitive deficits post-stroke, the improvement was specific to the anodal stimulation group, indicating that this non-invasive technique may be effective for enhancing cognitive function in stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the working memory of stroke patients using tDCS. Jo, JM., Kim, YH., Ko, MH., et al.[2022]

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. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. [2023]

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. England pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

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

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

8. 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]

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

Safety of transcranial direct current stimulation in healthy participants. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Transcranial Direct Current Stimulation in an Outpatient Rehabilitation Setting After Stroke. [2020]

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

Enhancing the working memory of stroke patients using tDCS. [2022]