tDCS for Cognitive Impairment

Overseen By Debbie Harrington, CCRP

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pittsburgh

Must not be taking: Anti-epileptic, Neuro-active drugs

Disqualifiers: Gait disorder, Parkinson's, Alzheimer's, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The objective is to evaluate if neuromodulation of the PFC can acutely improve sensory integration for balance performance in OTTBCS.

Will I have to stop taking my current medications?

The trial requires that you are not currently taking anti-epileptic medication. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of this treatment for cognitive impairment?

Research suggests that transcranial direct current stimulation (tDCS) may help improve cognitive functions like processing speed and working memory in people with mood and schizophrenia-spectrum disorders. However, its effects on general cognitive functioning and memory in Alzheimer's disease and mild cognitive impairment are either inconclusive or weak. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe and well-tolerated in humans, with no reports of serious or lasting harm in over 33,200 sessions. However, it can cause mild skin irritation and, in rare cases, more serious effects, so caution is advised, especially for healthy volunteers. ^{6 7 8 9 10}

How is the treatment tDCS different from other treatments for cognitive impairment?

Transcranial direct current stimulation (tDCS) is unique because it is a non-invasive method that uses a mild electrical current to stimulate the brain, potentially enhancing cognitive functions like memory and learning. Unlike traditional drug treatments, tDCS does not involve medication and is considered safe and well-tolerated, making it a promising option for conditions like Alzheimer's disease and mild cognitive impairment. ^{1 4 5 11 12}

Research Team

Brendan McNeish, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for women aged 60-85 who are breast cancer survivors (stages I-IIIc), can walk without help, own a device compatible with Fitbit, finished chemotherapy over a year ago, and speak English. They shouldn't have severe neurological diseases except CIPN or CRCD, second cancers, unstable conditions, certain neurodegenerative disorders, recent serious hospitalizations affecting movement or balance.

Inclusion Criteria

I can walk on my own without needing help from devices.

Own a device with capability to sync the Fitbit

I finished my last taxane chemotherapy over a year ago, after turning 60.

Exclusion Criteria

I cannot stand or walk by myself for a minute.

I have received immunotherapy in the past.

Any unstable medical condition

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active tDCS or sham tDCS to evaluate its effect on balance performance

8 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

Treatment Details

Interventions

• Sham tDCS (Behavioural Intervention)
• transcranial direct current stimulation (tDCS) (Neuromodulation)

Trial Overview The study tests if stimulating the brain's PFC with tDCS can immediately improve how well older breast cancer survivors maintain their balance by processing sensory information better compared to sham (fake) treatment.

Participant Groups

Group I: Sham tDCS, then Active tDCS Experimental Treatment 2 Interventions

Sham will be delivered in visit 2. Stimulation (tDCS) will be delivered in visit 3.

Group II: Active tDCS, then Sham tDCS Experimental Treatment 2 Interventions

Stimulation (tDCS) will be delivered in visit 2. Sham will be delivered in visit 3.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Findings from Research

Transcranial direct current stimulation (tDCS) is a safe and noninvasive method that shows promise in treating cognitive decline associated with Alzheimer's disease and mild cognitive impairment.

The review highlights the need for further large-scale clinical trials to better understand the mechanisms of tDCS and improve its application in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential of Transcranial Direct Current Stimulation in Alzheimer's Disease: Optimizing Trials Toward Clinical Use. Pilloni, G., Charvet, LE., Bikson, M., et al.[2022]

Anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex significantly improved cognitive tasks related to processing speed, selective attention, and planning in five older adults with mild cognitive impairment (MCI).

The study suggests that combining tDCS with cognitive stimulation programs may enhance cognitive performance in individuals with MCI, but further research is needed to explore long-term effects and practical applications in daily life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Transcranial Direct Current Stimulation on the Cognitive Functions in Older Adults with Mild Cognitive Impairment: A Pilot Study. Cruz Gonzalez, P., Fong, KNK., Brown, T.[2022]

Transcranial direct current stimulation (tDCS) has shown potential to improve cognitive functions such as processing speed, working memory, and executive functions in patients with mood disorders and schizophrenia, based on a systematic review of 41 studies.

The effects of tDCS on cognitive functioning and memory in Alzheimer's disease and mild cognitive impairment are less clear, with evidence being inconclusive or weak, highlighting the need for standardized protocols in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation and Cognition in Neuropsychiatric Disorders: Systematic Review of the Evidence and Future Directions. Ciullo, V., Spalletta, G., Caltagirone, C., 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) was found to be safe and well-tolerated in a study involving 20 patients with mild or major neurocognitive disorders, with an attrition rate of 0% and no serious adverse events reported.

However, the study did not find any statistically significant improvements in cognitive functioning when comparing the active tDCS group to the sham group, indicating that tDCS may not enhance cognitive performance in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Transcranial Direct Current Stimulation for Cognitive Rehabilitation in Patients With Mild or Major Neurocognitive Disorders: A Randomized Sham-Controlled Pilot Study. Inagawa, T., Yokoi, Y., Narita, Z., 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 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]

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]

High Definition transcranial direct current stimulation (HD-tDCS) is safe and well-tolerated in older adults, with no serious adverse events reported during a study involving 101 participants at stimulation intensities of 2 mA and 3 mA.

The study demonstrated effective blinding, as participants could not accurately distinguish between active and sham stimulation, indicating that HD-tDCS can be reliably used in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. Reckow, J., Rahman-Filipiak, A., Garcia, S., et al.[2020]

Transcranial direct current stimulation (tDCS) shows potential as a non-invasive treatment for improving memory in elderly individuals with mild cognitive impairment or Alzheimer's disease, but only five out of 13 studies reviewed demonstrated positive effects.

The study highlighted significant variability in tDCS protocols and noted methodological weaknesses, indicating a need for more rigorous research to better understand the effectiveness and long-term benefits of tDCS on memory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Transcranial Direct Current Stimulation on Memory of Elderly People with Mild Cognitive Impairment or Alzheimer's Disease: A Systematic Review. da Silva, ER., Rodrigues Menezes, IR., Brys, I.[2022]

Transcranial direct current stimulation (tDCS) was found to enhance working memory and learning potential in a study of 31 healthy older adults, with 16 receiving actual stimulation and 15 receiving a sham treatment.

The study demonstrated that tDCS is a safe and non-invasive method for improving cognitive functions in older adults, although it did not show significant effects on immediate memory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Immediate Memory, Potential Learning, and Working Memory with Transcranial Direct Current Stimulation in Healthy Older Adults. Satorres, E., Meléndez, JC., Pitarque, A., et al.[2023]

References

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

Potential of Transcranial Direct Current Stimulation in Alzheimer's Disease: Optimizing Trials Toward Clinical Use. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The Effects of Transcranial Direct Current Stimulation on the Cognitive Functions in Older Adults with Mild Cognitive Impairment: A Pilot Study. [2022]

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

Transcranial Direct Current Stimulation and Cognition in Neuropsychiatric Disorders: Systematic Review of the Evidence and Future Directions. [2022]

4. 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]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Transcranial Direct Current Stimulation for Cognitive Rehabilitation in Patients With Mild or Major Neurocognitive Disorders: A Randomized Sham-Controlled Pilot Study. [2022]

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

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

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

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

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

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]

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

Effects of Transcranial Direct Current Stimulation on Memory of Elderly People with Mild Cognitive Impairment or Alzheimer's Disease: A Systematic Review. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Enhancing Immediate Memory, Potential Learning, and Working Memory with Transcranial Direct Current Stimulation in Healthy Older Adults. [2023]