tDCS + Cognitive Training for Alzheimer's Disease

Overseen By Carlos Roncero, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baycrest

Disqualifiers: Stroke, TBI, Heart disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to help people with Alzheimer's Disease (AD) and Frontotemporal Dementia (FTD) manage their symptoms. It tests a technique called transcranial direct current stimulation (tDCS), which might be more effective at a higher intensity of 4mA compared to the usual 2mA. Participants will be divided into groups receiving either the 4mA stimulation, the 2mA stimulation, or a placebo (inactive treatment). This trial suits individuals with mild to moderate Alzheimer's Disease who can complete specific memory tasks and have no history of stroke or major heart problems. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options.

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 prior data suggests that transcranial direct current stimulation (tDCS) is safe for Alzheimer's Disease?

Research shows that transcranial direct current stimulation (tDCS) is generally safe. Studies have found that people usually tolerate tDCS well, experiencing only mild side effects such as tingling or itching. These effects are temporary and not serious. Other research has also shown that using tDCS alongside other treatments for Alzheimer's Disease is safe and can improve symptoms. Overall, tDCS has a strong safety record, making it a promising option for further research in treating conditions like Alzheimer's and Frontotemporal dementia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard Alzheimer's treatments that often focus on managing symptoms through medications like cholinesterase inhibitors and memantine, tDCS (transcranial direct current stimulation) offers a novel approach by using electrical currents to stimulate specific brain areas. This non-invasive technique is believed to enhance cognitive function by promoting neural plasticity, which is the brain's ability to reorganize itself by forming new neural connections. Researchers are excited because tDCS, combined with cognitive training, could potentially improve memory and cognitive processes more effectively than existing drugs, with fewer side effects. The trial tests different stimulation intensities (4mA and 2mA) to find the most effective dose, providing valuable insights into optimizing this innovative treatment method.

What evidence suggests that this trial's treatments could be effective for Alzheimer's Disease?

Research has shown that transcranial direct current stimulation (tDCS) can improve thinking skills in people with Alzheimer's Disease (AD). Studies indicate that tDCS enhances overall mental abilities more effectively than treatments without it. Multiple tDCS sessions have significantly boosted thinking skills in older adults with AD. Additionally, having tDCS sessions twice a day might further improve cognitive function. This trial will compare different strengths of tDCS, including 4mA and 2mA stimulation, to determine the most effective approach. The challenge lies in finding the best way to use tDCS effectively, but increasing the strength of the stimulation could lead to better results for more people. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with mild to moderate Alzheimer's Disease who score between 18 and 25 on the MoCA cognitive test and can perform a memory task. It excludes those with stroke or brain injury history, metal implants/shunts in their body, or significant heart disease, alcoholism, or drug use.

Inclusion Criteria

Mild to Moderate AD

Score between 18 and 25 on the MoCA

I can perform the N-Back memory task.

Exclusion Criteria

No shunts or metal in the body

No history of significant heart disease, alcoholism, and drug use

I have never had a stroke or traumatic brain injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial direct current stimulation (tDCS) at either 2mA or 4mA, or a sham treatment

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• tDCS

Trial Overview The study tests if transcranial direct current stimulation (tDCS) at a higher intensity of 4mA combined with cognitive training can be more effective than the conventional 2mA for improving symptoms in Alzheimer's patients.

How Is the Trial Designed?

Group I: 4mA Stimulation Experimental Treatment 1 Intervention

Group II: 2mA Stimulation Active Control 1 Intervention

Group III: SHAM Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Baycrest

Lead Sponsor

Trials

46

Recruited

6,900+

BrightFocus Foundation

Collaborator

Trials

5

Recruited

430+

Published Research Related to This Trial

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]

In a study involving 34 Alzheimer's disease patients, both anodal and cathodal transcranial direct current stimulation (tDCS) significantly improved cognitive function as measured by the mini-mental state examination (MMSE) compared to sham stimulation.

tDCS also reduced the P300 latency, a measure associated with cognitive processing, indicating potential benefits in neurorehabilitation for Alzheimer's patients, although it did not affect motor cortex excitability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind randomized clinical trial on the efficacy of cortical direct current stimulation for the treatment of Alzheimer's disease. Khedr, EM., Gamal, NF., El-Fetoh, NA., et al.[2022]

In a study involving 36 patients with Alzheimer's disease, multisite anodal transcranial direct current stimulation (tDCS) combined with cognitive stimulation significantly delayed cognitive decline compared to a sham treatment, as measured by the ADAS-cog scale.

The active tDCS+CS group showed greater changes in EEG coherence, indicating enhanced brain activity, which correlated with improvements in cognitive performance, suggesting that this combined approach may effectively modulate brain function in Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of multisite anodal transcranial direct current stimulation combined with cognitive stimulation in patients with Alzheimer's disease and its neurophysiological correlates: A double-blind randomized clinical trial. Andrade, SM., Machado, DGDS., Silva-Sauerc, LD., 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]

In a study involving 15 Alzheimer's disease patients, five consecutive sessions of anodal transcranial direct current stimulation (tDCS) significantly improved visual recognition memory by 8.99% compared to a 2.62% decline with sham stimulation.

The memory improvement persisted for at least 4 weeks after the treatment, suggesting that anodal tDCS could be a promising adjuvant therapy for enhancing memory in Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged visual memory enhancement after direct current stimulation in Alzheimer's disease. Boggio, PS., Ferrucci, R., Mameli, F., et al.[2022]

In a study involving 10 patients with Alzheimer's disease, anodal transcranial direct current stimulation (AtDCS) significantly improved recognition memory performance, while cathodal tDCS (CtDCS) led to a decline in performance.

tDCS is shown to be a safe and inexpensive method that could enhance cognitive function in Alzheimer's patients, suggesting potential for further research on its use alongside other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation improves recognition memory in Alzheimer disease. Ferrucci, R., Mameli, F., Guidi, I., et al.[2022]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39089145/

Systematic review and meta-analysis of transcranial direct ... Conclusion: The tDCS can ameliorate the global cognition of patients with MCI and AD, and it has a better rehabilitation effect than non-tDCS or sham-tDCS.

2. alzres.biomedcentral.com alzres.biomedcentral.com/articles/10.1186/s13195-025-01677-y

A systematic review and meta-analysis of the impact of ... Our analysis revealed that multiple sessions of tDCS significantly improved the global cognition of older people with AD but not of those with ...

3. gpsych.bmj.com gpsych.bmj.com/content/36/6/e101166

Impact of twice-a-day transcranial direct current stimulation ... Our research indicates for the first time that twice-a-day tDCS may improve the cognitive function of patients with AD.

4. nature.com nature.com/articles/s41598-024-67664-9

Effects of transcranial direct current stimulation on ... This study evaluates the cognitive effects of sequential tDCS on 63 mild cognitive impairment (MCI) patients, considering AD risk factors.

5. cpn.or.kr cpn.or.kr/journal/view.html?uid=1320&vmd=Full&

A Meta-analysis of Effects, Adherence and Adverse Effects But overall, the results of our meta-analysis showed that tDCS was effective in improving cognition of patients with AD. Also, on evaluating for the type of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11040101/

Safety and feasibility of optimized transcranial direct current ... Therefore, this study aims to determine the feasibility and safety of applying tDCS treatment using optimized and personalized tDCS electrode ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X22002443

Efficacy and safety of simultaneous rTMS–tDCS over ... Simultaneous application of rTMS–tDCS in Alzheimer's Disease is safe and promising. •. rTMS–tDCS produces greater improvement in neuropsychiatric symptoms ...

8. thejcn.com thejcn.com/DOIx.php?id=10.3988/jcn.2022.18.4.391

Potential of Transcranial Direct Current Stimulation in ... tDCS is a safe and well-tolerated treatment approach7, 8 that can be easily combined with simultaneous rehabilitative activities (e.g., ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02518412

Transcranial Direct Current Stimulation (tDCS) as a ... A total of 30 patients with Alzheimer disease will receive tDCS treatment for 30 minutes, six times. Half of the patients will undergo sham ...