128 Participants Needed

Transcranial Direct Current Stimulation for Dementia

(TDCS4MCR Trial)

Recruiting at 1 trial location
KB
JS
Overseen ByJuhi Salecha, MS
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Hebrew SeniorLife
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?

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.12345

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.24678

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.247910

Who Is on the Research Team?

BM

Brad Manor, PhD

Principal Investigator

Hebrew SeniorLife

JH

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
See 5 more

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
See 16 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Personalized Transcranial Direct Current Stimulation (tDCS)Experimental Treatment1 Intervention
Group II: Combination Arm; Sham Plus Personalized Transcranial Direct Current Stimulation (tDCS)Active Control2 Interventions

Find a Clinic Near You

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.
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.
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.
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]

Citations

Behavioural and electrophysiological modulations induced by transcranial direct current stimulation in healthy elderly and Alzheimer's disease patients: A pilot study. [2020]
Maximizing the Treatment Benefit of tDCS in Neurodegenerative Anomia. [2022]
Inferior parietal transcranial direct current stimulation with training improves cognition in anomic Alzheimer's disease and frontotemporal dementia. [2022]
Transcranial direct current stimulation improves recognition memory in Alzheimer disease. [2022]
Potential of Transcranial Direct Current Stimulation in Alzheimer's Disease: Optimizing Trials Toward Clinical Use. [2022]
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]
Transcranial direct current stimulation for depression in Alzheimer's disease: study protocol for a randomized controlled trial. [2022]
Combined Effects of tDCS and Language/Cognitive Intervention on the Naming of Dementia Patients: A Systematic Review and Meta-Analysis. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Transcranial Direct Current Stimulation Improves Cognitive Function in Mild to Moderate Alzheimer Disease: A Meta-Analysis. [2020]
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