tDCS + Cognitive Training for Dementia

KT
J"
Overseen ByJessica "Jessie" Gallegos
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining non-invasive brain stimulation with brain exercises can improve thinking skills in people with memory and language issues. The researchers use transcranial direct current stimulation (tDCS) to gently stimulate the brain, alongside cognitive training activities. Participants will help determine if these methods can enhance mental abilities in conditions like Primary Progressive Aphasia or mild Alzheimer's. Individuals diagnosed with mild Alzheimer's or dementia who are proficient in English might be suitable for this study. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could lead to new ways to support cognitive health.

Will I have to stop taking my current medications?

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 prior data suggests that this method is safe for individuals with dementia?

Research has shown that using transcranial direct current stimulation (tDCS) at home is safe and well-tolerated. Studies have demonstrated its safe use for up to 20 days. tDCS helps improve cognitive function, enhancing how well the brain thinks and remembers. One study found that using tDCS at home is safe and practical for people with mild cognitive impairment (MCI), indicating it can be done easily and without issues.

Although tDCS is generally safe, consulting a doctor is important to determine if it's appropriate.12345

Why are researchers excited about this trial?

Unlike traditional treatments for dementia that typically focus on medications to manage symptoms, the home-based tDCS (transcranial Direct Current Stimulation) approach offers a non-invasive method that targets the brain's dorsolateral prefrontal cortex (DLPFC) directly. Researchers are excited because this method not only involves electrical stimulation to enhance brain activity but also combines cognitive interventions to potentially improve cognitive function. This dual approach could offer a more holistic way to address cognitive decline, setting it apart from existing drug therapies that primarily aim to slow disease progression. Additionally, the ability to administer this treatment at home could make it more accessible and convenient for patients and caregivers.

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

Studies have shown that transcranial direct current stimulation (tDCS) can improve thinking skills in people with Alzheimer's disease. Research indicates that individuals with Alzheimer's benefit more from tDCS than those with mild cognitive impairment (MCI) or other types of dementia. Using tDCS at home has proven safe and practical for people with memory and thinking problems, showing promise for enhancing these skills. Specifically, applying tDCS to a brain area involved in decision-making and problem-solving has improved attention and language skills. In this trial, participants will receive either active tDCS on the DLPFC combined with cognitive interventions or active tDCS on the DLPFC only. Although more research is needed, early findings suggest that combining tDCS with brain exercises could further enhance these benefits.12356

Who Is on the Research Team?

Kyrana Tsapkini, PhD

Kyrana Tsapkini, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for right-handed individuals who have been clinically diagnosed with Primary Progressive Aphasia (PPA), Frontotemporal Dementia (FTD), Mild Cognitive Impairment (MCI) or mild Alzheimer's Disease, based on neuropsychological and language testing, MRI scans, and clinical assessment. Participants must speak English fluently and have at least a high-school education. Those with uncorrected vision/hearing issues, other learning disorders, inability to follow directions, severe psychiatric conditions or previous neurological disorders like stroke are excluded.

Inclusion Criteria

Must be right-handed
Must be proficient in English
I have been diagnosed with PPA, FTD, MCI, or mild Alzheimer's based on tests and assessments.
See 1 more

Exclusion Criteria

Pre-existing psychiatric disorders such as behavioral disturbances, severe depression, and schizophrenia that do not allow them to comply or follow the study schedule and requirements such as repeated evaluation and therapy
I have had a stroke or another brain disorder.
I cannot follow instructions for basic tasks.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 50 treatment sessions of tDCS and/or cognitive training over 10 weeks

10 weeks
Home-based sessions

Washout

A three-month washout period between treatment phases

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Home-based tDCS
Trial Overview The study tests the effects of non-invasive brain stimulation using transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex combined with computerized cognitive training from BrainHQ. The goal is to improve executive functioning in patients with PPA associated with FTD or Alzheimer's Disease pathology as well as those with MCI/Alzheimer's Disease.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Active tDCS on the DLPFC onlyExperimental Treatment1 Intervention
Group II: Active tDCS on the DLPFC + Cognitive Intervention(s)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Ybrain Inc.

Industry Sponsor

Trials
12
Recruited
690+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+

Published Research Related to This Trial

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.
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]
This study involves 100 older adults with mild-to-moderate Alzheimer's disease and investigates the effects of 6 months of at-home transcranial direct current stimulation (tDCS) on cognitive performance and other outcomes.
The trial aims to provide robust evidence on the safety and efficacy of tDCS as a treatment for Alzheimer's symptoms, addressing limitations of previous studies that had smaller sample sizes and shorter stimulation durations.
Neurostimulation for cognitive enhancement in Alzheimer's disease (the NICE-AD study): a randomized clinical trial.Gulley, E., Verghese, J., Blumen, HM., 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.
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]

Citations

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 ...
Home-Based Transcranial Direct Current Stimulation to ...Specifically, RS-tDCS is effective in patients with moderate cognitive decline. Additionally, these data demonstrate the potential to enhance home-based ...
Efficacy of Transcranial Direct Current Stimulation on...The study findings suggest that tDCS is effective in improving global cognition in participants with Alzheimer's dementia but not MCI.
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38804028/
Effect of Home-Based Transcranial Direct Current ...Conclusion: This preliminary result suggests that home-based tDCS may be a promising treatment option for MCI patients; however, it requires more attention and ...
Home-based cognitive remediation and transcranial direct ...This study demonstrates that home-based CR+tDCS is feasible and safe in patients with MCI or rMDD, and could improve cognition in patients and ...
Safety and feasibility of optimized transcranial direct ...Previous research has shown that tDCS can be safely used for 20 days and has significant effects on cognitive function (11, 12). Although there ...
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