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?

There is currently little symptomatic therapy for Alzheimer's Disease (AD) and nothing effective for individuals with Frontotemporal dementia (FTD). However, neuromodulation with transcranial direct current stimulation (tDCS) has the potential to be a clinically effective therapy for both AD and FTD. The challenge now is to specify the parameters and conditions under which tDCS is most effective to transition from the laboratory to clinical medicine. tDCS studies typically report significant group effects despite the variability demonstrated among participants, with some showing clear, meaningful improvement, while others only show statistical improvement or none at all. These variable results may be related to the conventional stimulation intensity level of 2mA. The investigators predict that administering tDCS at 4.0 mA, a more significant number of participants would show a meaningful response, and those who improve at 2mA may improve even more from 4.0mA due to having a larger electric field produced. The investigators aim to test this hypothesis in people with Alzheimer's Disease.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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 adverse effects or irreversible injury across over 33,200 sessions and 1,000 subjects, including potentially vulnerable populations like the elderly. ^{1 2 3 4 5}

How is the treatment tDCS + Cognitive Training different from other treatments for Alzheimer's disease?

tDCS (Transcranial Direct Current Stimulation) is a unique treatment for Alzheimer's disease because it is a non-invasive method that uses electrical currents to stimulate the brain, potentially improving cognitive function without the use of drugs. This approach is combined with cognitive training to enhance its effects, making it different from traditional drug-based therapies. ^{1 2 3 4 6}

What data supports the effectiveness of the treatment tDCS for Alzheimer's Disease?

Research shows that transcranial direct current stimulation (tDCS) can improve memory and cognitive performance in people with Alzheimer's disease. Studies have found that tDCS is a safe and promising method for slowing cognitive decline in Alzheimer's patients. ^{1 2 3 4 7}

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

I have never had a stroke or traumatic brain injury.

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

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

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]

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 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) 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 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]

Citations

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

Transcranial direct current stimulation improves recognition memory in Alzheimer disease. [2022]

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

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

3. 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]

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

Prolonged visual memory enhancement after direct current stimulation in Alzheimer's disease. [2022]

5. Switzerland 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. [2022]

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

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

7. France 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. [2022]