Transcranial Direct Current Stimulation for Dementia

(TDCS4MCR Trial)

Recruiting at 1 trial location

Overseen By Juhi Salecha, MS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Hebrew SeniorLife

Disqualifiers: Dementia, Major psychiatric disorder, Seizures, others

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

Compensation: Varies

Number of Visits: 17

Duration: 6 months

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The objective of this study is to determine the effects of a 6-month, home-based personalized transcranial direct current stimulation (tDCS) intervention targeting the left dorsolateral prefrontal cortex on cognitive function, dual task standing and walking, and other metrics of mobility in older adults with motoric cognitive risk syndrome (MCR).

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, your medications and medical history will be reviewed by a physician to decide on your inclusion in the study.

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with no reports of serious adverse effects or irreversible injury in over 33,200 sessions across various populations, including potentially vulnerable groups like the elderly. ^{1 2 3 4 5}

How is transcranial direct current stimulation (tDCS) different from other treatments for dementia?

Transcranial direct current stimulation (tDCS) is unique because it is a noninvasive method that uses electrical currents to stimulate the brain, unlike traditional drug treatments. It is being explored for its potential to improve cognitive function and delay cognitive decline in dementia patients, offering a non-drug alternative for managing symptoms. ^{2 4 6 7 8}

What data supports the effectiveness of this treatment for dementia?

Research shows that transcranial direct current stimulation (tDCS) can help improve cognitive functions like memory and picture-naming abilities in people with Alzheimer's disease and other types of dementia. This suggests that tDCS might be a promising non-drug treatment to slow down or improve symptoms of dementia. ^{2 4 7 9 10}

Who Is on the Research Team?

Brad Manor, PhD

Principal Investigator

Hebrew SeniorLife

Jeff Hausdorff, PhD

Principal Investigator

Tel-Aviv Sourasky Medical Center

Are You a Good Fit for This Trial?

This trial is for older adults with motoric cognitive risk syndrome (MCR), which often includes issues with memory and movement. Participants should be experiencing early signs of cognitive decline and mobility disability but specifics on inclusion criteria are not provided.

Inclusion Criteria

Montreal Cognitive Assessment (MoCA) score ≥21

Access to reliable WiFi in the participant's home

Identification of an eligible informant

Exclusion Criteria

Formal education less than the 8th grade

Any current diagnosis of a major psychiatric disorder

Presence of dementia as defined by a Clinical Dementia Rating (CDR) scale of 1 or higher, previous physician diagnosis of dementia, or performance on the proposed neuropsychological test battery in the dementia range

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Phase

Participants receive an open-label 2-week, 10-session tDCS intervention

2 weeks

10 sessions (home-based)

Treatment

Participants receive 5 weekly home-based tDCS sessions for 6 months or a combination of tDCS and sham sessions

6 months

5 sessions per week (home-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Assessments at baseline, after 2 weeks, 3 months, 6 months, and 9 months

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Transcranial Direct Current Stimulation (tDCS)

Trial Overview The study tests a home-based brain stimulation technique called personalized transcranial direct current stimulation (tDCS) targeting the brain's left dorsolateral prefrontal cortex over six months, to see if it improves thinking skills and mobility in MCR patients.

How Is the Trial Designed?

Group I: Personalized Transcranial Direct Current Stimulation (tDCS) Experimental Treatment 1 Intervention

After an initial open-label 2-week home-based transcranial direct current stimulation (tDCS) intervention, participants will receive 5 weekly home-based tDCS sessions for 6 months. Baseline MRIs will enable personalization of tDCS via current flow modeling for optimization to each participant with the goal of generating an average electric field of 0.25 V/m within their identified left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA and the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.

Group II: Combination Arm; Sham Plus Personalized Transcranial Direct Current Stimulation (tDCS) Active Control 2 Interventions

After an initial open-label 2-week home-based transcranial direct current stimulation (tDCS) intervention, participants will receive a combination arm of five weekly tDCS sessions for 3 months before or after five weekly sessions of sham for 3 months. The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS. Participants in the combination arm will not know whether they are receiving tDCS or sham during the first or second 3-month period.

Who Is Running the Clinical Trial?

Hebrew SeniorLife

Lead Sponsor

Trials

52

Recruited

273,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Tel Aviv Medical Center

Collaborator

Trials

29

Recruited

8,100+

Published Research Related to This Trial

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) significantly improved picture naming abilities in participants with anomic Alzheimer Disease or Frontotemporal dementia, particularly with the left inferior parietotemporal montage, showing lasting effects even 2 weeks post-stimulation.

The effectiveness of tDCS varied based on the montage used and the participants' specific diagnoses, indicating that personalized approaches may be necessary for optimal outcomes in treating anomia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximizing the Treatment Benefit of tDCS in Neurodegenerative Anomia. Roncero, C., Service, E., De Caro, M., et al.[2022]

Transcranial direct current stimulation (tDCS) significantly improved picture-naming abilities in individuals with anomic Alzheimer or frontotemporal dementias, with a 40% improvement compared to 19% with sham stimulation, lasting at least 2 weeks after treatment.

The benefits of tDCS not only enhanced trained picture-naming tasks but also showed a small positive effect on untrained items and other cognitive tasks, suggesting a broader impact on cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inferior parietal transcranial direct current stimulation with training improves cognition in anomic Alzheimer's disease and frontotemporal dementia. Roncero, C., Kniefel, H., Service, E., 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]

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]

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]

This study protocol aims to evaluate the safety and clinical effects of transcranial direct current stimulation (tDCS) on depression in Alzheimer's patients aged over 65, addressing a gap in research for older adults.

The trial is designed as a randomized controlled study with blinding, comparing active tDCS to a sham treatment, and will assess participants' depression and cognitive function at multiple time points to determine the intervention's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for depression in Alzheimer's disease: study protocol for a randomized controlled trial. Narita, Z., Yokoi, Y.[2022]

A meta-analysis of 4 studies found that transcranial direct current stimulation (tDCS) alone did not significantly improve the naming ability of patients with dementia.

However, when tDCS was combined with language or cognitive training, it resulted in a large effect size (SMD=0.72), indicating a significant improvement in naming ability for dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Effects of tDCS and Language/Cognitive Intervention on the Naming of Dementia Patients: A Systematic Review and Meta-Analysis. Byeon, H.[2022]

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]

Citations

1. 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]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Maximizing the Treatment Benefit of tDCS in Neurodegenerative Anomia. [2022]

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

Inferior parietal transcranial direct current stimulation with training improves cognition in anomic Alzheimer's disease and frontotemporal dementia. [2022]

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

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

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

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

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

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

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

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for depression in Alzheimer's disease: study protocol for a randomized controlled trial. [2022]

9. Iran pubmed.ncbi.nlm.nih.gov

Combined Effects of tDCS and Language/Cognitive Intervention on the Naming of Dementia Patients: A Systematic Review and Meta-Analysis. [2022]

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

Transcranial Direct Current Stimulation Improves Cognitive Function in Mild to Moderate Alzheimer Disease: A Meta-Analysis. [2020]