tDCS for Alzheimer's Disease

Overseen By Shelley Solomon

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lady Davis Institute

Disqualifiers: Metal in head, others

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

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

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how transcranial direct current stimulation (tDCS), a non-invasive brain treatment, can assist individuals with Alzheimer's or other forms of dementia when used at home. The researchers aim to determine if regular tDCS treatments can improve symptoms over time. Participants will receive guidance on safely using tDCS devices and will report their condition monthly for at least two years. This trial suits those diagnosed with Alzheimer's or another type of dementia who wish to try tDCS at home. However, it is not safe for individuals with metal in their head. As an unphased trial, this study provides a unique opportunity for patients to explore innovative home-based treatments for dementia.

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 this device is safe for at-home use?

Research has shown that transcranial direct current stimulation (tDCS) is safe for people with Alzheimer's disease. One study on the safety and practicality of tDCS found that most participants tolerated it well, experiencing no serious side effects.

Another study found that tDCS could improve thinking and memory in Alzheimer's patients, suggesting it might be both safe and beneficial. Importantly, a review of several studies found no major negative effects from tDCS treatments, which is encouraging for those considering its use at home.

Overall, the evidence suggests that tDCS is a safe option with potential benefits for brain health in Alzheimer's patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial direct current stimulation (tDCS) for Alzheimer's disease because it offers a non-invasive, at-home treatment option. Unlike standard medications that involve oral intake or injections, tDCS uses a low electrical current applied through the scalp to potentially improve cognitive function. This approach targets brain activity directly, which could enhance memory and cognitive skills without the side effects commonly associated with current drug treatments. The ability for patients to use it at home also adds a level of convenience and accessibility that is not typically available with traditional therapies.

What evidence suggests that tDCS is effective for Alzheimer's Disease?

Research has shown that transcranial direct current stimulation (tDCS), which participants in this trial will conduct at home, can improve thinking skills in people with Alzheimer's disease. Studies indicate that individuals with Alzheimer's experience more noticeable benefits compared to those with milder memory problems, suggesting that tDCS might enhance memory and learning abilities. A review of several studies found that tDCS is more effective than placebo treatments, proving it is not merely a placebo effect. Overall, tDCS appears promising for boosting brain function in those with Alzheimer's. ^{2 6 7 8 9}

Who Is on the Research Team?

Carlos Roncero, PhD

Principal Investigator

Baycrest

Are You a Good Fit for This Trial?

This trial is for individuals with Alzheimer's Disease or other forms of dementia, such as Primary Progressive Aphasia. It's designed for those who have used tDCS in a lab setting and are interested in continuing treatment at home. Participants will be advised on purchasing their own tDCS machine and trained to use it properly.

Inclusion Criteria

I have been diagnosed with Alzheimer's or another type of dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Equipment Acquisition

Participants are assisted in obtaining their own tDCS machine and trained on how to properly administer tDCS at home

4 weeks

1 visit (in-person)

Longitudinal Monitoring

Participants conduct tDCS at home and submit monthly reports for monitoring of effectiveness and condition

2 years

Monthly reports (virtual)

Follow-up

Participants are monitored for safety and effectiveness after the main study period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation

Trial Overview The study tests the effectiveness of Transcranial Direct Current Stimulation (tDCS) administered at home by participants with dementia. The researchers will monitor the condition of these individuals over two years through monthly reports to assess how well tDCS works outside a clinical setting.

How Is the Trial Designed?

Group I: At Home tDCS Users Experimental Treatment 1 Intervention

Participants conducting tDCS at home

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?

Lady Davis Institute

Lead Sponsor

Trials

50

Recruited

6,600+

Published Research Related to This Trial

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 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]

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]

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) significantly improved cognitive function in patients with mild to moderate Alzheimer's disease, based on a meta-analysis of seven studies involving 146 patients, with a standardized mean difference of 0.37.

Single sessions of tDCS were effective, particularly when stimulating the temporal cortex, while repeated sessions and lower current densities did not show significant benefits, highlighting the need for careful consideration of treatment parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation Improves Cognitive Function in Mild to Moderate Alzheimer Disease: A Meta-Analysis. Cai, M., Guo, Z., Xing, G., et al.[2020]

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) 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 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]

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 ... People with AD showed greater improvements compared to those with MCI or dementia (SMD = 0.91, p = 0.02). However, tDCS did not significantly ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2274580724006150

High definition transcranial direct current stimulation as an ... The primary outcome was change in total learning and delayed recall on the Rey Auditory Verbal Learning Test (RAVLT) immediately post-treatment and at 8-weeks.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8553534/

Role of Transcranial Direct Current Stimulation in the ... 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 ...

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

Potential of Transcranial Direct Current Stimulation in ... A double-blind randomized clinical trial on the efficacy of cortical direct current stimulation for the treatment of Alzheimer's disease.

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

Safety and feasibility of optimized transcranial direct current ... This study aims to determine the feasibility and safety of applying tDCS treatment using optimized and personalized tDCS electrode positions in patients with ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0197457224001927

Systematic review and meta-analysis of transcranial ... 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.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4804486/

Transcranial direct current stimulation as a memory ... The purpose of this study was to assess the efficacy of transcranial direct current stimulation (tDCS) on verbal memory function in patients with Alzheimer's ...

9. 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 ...