tDCS + Cognitive Training for Dementia

Overseen By Jessica "Jessie" Gallegos

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Stroke, Schizophrenia, Severe depression, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this research is to evaluate the effects of non-invasive brain stimulation and computerized cognitive training on executive functioning in individuals with Primary Progressive Aphasia (PPA), mild cognitive impairment (MCI), or dementia. In this study, investigators will use transcranial direct current stimulation (tDCS) to stimulate the left dorsolateral prefrontal cortex (DLPFC). Previous studies have demonstrated that tDCS over the DLPFC led to improvements in attention deficit caused by stroke, Parkinson's Disease, and major depression as well as language deficits caused by neurodegenerative conditions such as primary progressive aphasia or mild cognitive impairment. The investigators seek to expand on this literature by investigating how anodal tDCS paired with and without cognitive training will impact executive functioning in PPA with Frontotemporal Dementia or Alzheimer's Disease pathology and Mild Cognitive Impairment/Alzheimer's Disease (e.g. shifting, updating, monitoring, and manipulation).

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 data supports the effectiveness of the treatment Home-based tDCS for dementia?

Research shows that transcranial direct current stimulation (tDCS) can improve cognitive function in Alzheimer's disease immediately after treatment, especially when applied to certain brain areas. Additionally, a case study suggests that tDCS may help stabilize cognitive function when used alongside other treatments. ^{1 2 3 4 5}

Is home-based tDCS safe for humans?

Studies suggest that home-based transcranial direct current stimulation (tDCS) is generally safe for humans, with no troublesome side effects reported in Alzheimer's patients over several months of use. ^{2 5 6 7 8}

How is home-based tDCS with cognitive training different from other treatments for dementia?

Home-based tDCS (transcranial direct current stimulation) is unique because it allows patients to self-administer the treatment at home, reducing the need for frequent hospital visits. This non-invasive method uses a low electrical current applied to the scalp to potentially enhance cognitive function, and when combined with cognitive training, it may offer a novel approach to managing dementia symptoms. ^{2 3 5 6 9}

Research Team

Kyrana Tsapkini, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Active tDCS on the DLPFC only Experimental Treatment 1 Intervention

Participants will receive active tDCS on the DLPFC-only intervention first and then receive active tDCS + Cognitive Intervention(s) after a three-month washout period.

Group II: Active tDCS on the DLPFC + Cognitive Intervention(s) Experimental Treatment 2 Interventions

Participants will receive active tDCS on DLPFC + Cognitive Intervention(s) first and then receive only active tDCS Intervention after a three-month washout period.

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+

Findings from Research

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

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) 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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for global cognition in Alzheimer's disease: a systemic review and meta-analysis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A four-month home-based tDCS study on patients with Alzheimer's disease. [2022]

3. 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]

4. Brazil pubmed.ncbi.nlm.nih.gov

Adjuvant transcranial direct current stimulation for treating Alzheimer's disease: A case study. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Effect of home-based transcranial direct current stimulation (tDCS) on cognitive function in patients with mild cognitive impairment: a study protocol for a randomized, double-blind, cross-over study. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Neurostimulation for cognitive enhancement in Alzheimer's disease (the NICE-AD study): a randomized clinical trial. [2022]

7. 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]

8. 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]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Potentials and limits to enhance cognitive functions in healthy and pathological aging by tDCS. [2022]