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?

This trial explores how a home-based brain stimulation method, transcranial direct current stimulation (tDCS), can improve thinking and movement in older adults with motoric cognitive risk syndrome. Participants will receive either the actual tDCS treatment or a version that feels similar but does not affect brain activity. The study targets individuals aged 65-90 who have noticed memory issues and walk slower than usual but can still perform daily activities without major assistance. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance cognitive and motor functions in older adults.

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.

What prior data suggests that this transcranial direct current stimulation (tDCS) is safe for older adults with motoric cognitive risk syndrome (MCR)?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe for people. One study on the safety and practicality of tDCS found that participants tolerated it well, experiencing only mild side effects like tingling or slight itchiness at the electrode sites. These effects were temporary and not serious.

Another review examined several tDCS sessions and found that it improved thinking skills in older adults with Alzheimer's disease without causing major safety concerns. Using tDCS in brain research, particularly for dementia, is considered relatively safe.

Overall, evidence suggests that tDCS is a safe option for those interested in joining clinical trials. Safety in clinical trials is always monitored to protect participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Personalized Transcranial Direct Current Stimulation (tDCS) for dementia because it offers a tailored approach to brain stimulation. Unlike traditional treatments for dementia, such as medications targeting neurotransmitter systems, personalized tDCS uses electrical currents optimized to each individual's brain structure, potentially enhancing cognitive functions more effectively. The combination arm introduces an innovative active sham method, ensuring participants experience the sensations of tDCS without actual stimulation, which helps in accurately assessing the treatment's effectiveness. This personalization and novel sham technique could mean more precise and effective management of dementia symptoms.

What evidence suggests that personalized transcranial direct current stimulation (tDCS) is effective for dementia?

Research has shown that transcranial direct current stimulation (tDCS) can enhance brain function. Studies have found that tDCS significantly improves scores on memory and thinking tests, such as the MoCA and MMSE. These benefits have been observed in older adults, particularly those with Alzheimer's disease. While results can vary, targeting a specific brain area involved in thinking and memory with tDCS has shown promise. In this trial, participants will receive either personalized tDCS or a combination of sham and personalized tDCS. Some studies suggest that multiple tDCS sessions could improve overall brain function in older individuals. ^{2 6 7 8 9}

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

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]

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) 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]

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]

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]

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]

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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11989800/

Effectiveness of Transcranial Stimulation on Cognitive ... The results obtained showed significant improvements in MoCA and MMSE scores after the application of tDCS, suggesting a positive effect on ...

2. alzres.biomedcentral.com alzres.biomedcentral.com/articles/10.1186/s13195-025-01677-y

A systematic review and meta-analysis of the impact of ... Our analysis revealed that multiple sessions of tDCS significantly improved the global cognition of older people with AD but not of those with ...

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

Systematic review and meta-analysis of transcranial ... The meta-analysis found that tDCS increased MMSE, MoCA, MODA scores and reduced the P300 latency scores (all P < 0.05). Conclusion. The tDCS can ameliorate the ...

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1356073/full

Safety and feasibility of optimized transcranial direct ... tDCS has shown mixed results regarding its effectiveness in improving cognitive function. A recent study reported that tDCS over the DLPFC ...

5. gpsych.bmj.com gpsych.bmj.com/content/36/6/e101166

Impact of twice-a-day transcranial direct current stimulation ... Conclusions Our research indicates for the first time that twice-a-day tDCS may improve the cognitive function of patients with AD. This study ...

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/pii/S1041610224039474

Effects of Transcranial Direct Current Stimulation (tDCS) on ... Brain stimulation in dementia research, especially with relatively safe tDCS, has been taken seriously recently. In theory, tDCS affects long-term synaptic ...

8. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06821568?draw=2&rank=1

Home-Based Brain Stimulation for Motoric Cognitive Risk ... The objective of this study is to determine the effects of a 6-month, home-based personalized transcranial direct current stimulation (tDCS) intervention ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11306417/

Efficacy and Safety of Transcranial Magnetic Stimulation on ... TMS was safe and well tolerated with infrequent serious adverse events. Keywords: cognition, dementia, meta-analysis, MCI, mild cognitive ...