100 Participants Needed

tDCS for Alzheimer's Disease

(NICE-AD Trial)

JV
EA
EW
MM
MC
Overseen ByMirnova Ceide, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Albert Einstein College of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current dementia medications, but your medication regimen should be stable for at least 4 weeks before joining. Your doctor can still adjust your medications during the trial if needed.

What data supports the effectiveness of the treatment tDCS for Alzheimer's Disease?

Research shows that transcranial direct current stimulation (tDCS) has been effective in reducing symptoms of depression, with significant improvements noted in patients after several weeks of treatment. This suggests that tDCS may have potential benefits for other brain-related conditions, like Alzheimer's Disease, although direct evidence for Alzheimer's is not provided.12345

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

Research shows that transcranial direct current stimulation (tDCS) is generally safe for humans when used in conventional protocols, with no reports of serious adverse effects in over 33,200 sessions. However, some studies caution that tDCS could potentially be harmful, so it's important to follow medical guidance and use approved devices.46789

How does tDCS treatment for Alzheimer's differ from other treatments?

tDCS (transcranial direct current stimulation) is a unique treatment for Alzheimer's because it is a noninvasive method that uses a small electrical current to stimulate the brain, potentially improving cognitive function. Unlike traditional drug treatments, tDCS can be administered at home and focuses on modulating brain activity rather than altering brain chemistry.24101112

What is the purpose of this trial?

The prevalence of Alzheimer's Disease (AD) is rising, but existing medications provide only modest control of cognitive decline and associated symptoms, and novel therapies are urgently needed. This randomized sham-controlled trial will determine if an innovative low-risk remotely-supervised transcranial Direct Current Stimulation (tDCS) applied over the area of the dorsolateral prefrontal cortex for 30 minutes at the intensity of 2 mA five times per week for 6 months at home can improve cognitive performance and symptoms and modulate neuroimaging markers of neuroplasticity in 100 patients with mild to moderate AD. If effective, this novel intervention can substantially enhance AD symptom management at home, improve quality of life of AD patients and their families, and reduce burden associated with this debilitating illness.

Research Team

JV

Joe Verghese, MD

Principal Investigator

Stony Brook University

LD

Lara Dhingra, PhD

Principal Investigator

Metropolitan Jewish Health System

MC

Mirnova Ceide, MD

Principal Investigator

Albert Einstein College of Medicine

Eligibility Criteria

This trial is for people aged 60 or older with mild to moderate Alzheimer's Disease, diagnosed by specialists. Participants must be stable on dementia medications if any, speak English or Spanish well enough for study procedures, and agree to an MRI scan. Those with unstable health conditions, skin issues where electrodes are placed, head trauma history, metal implants in the head/neck, or involved in other studies can't join.

Inclusion Criteria

I am willing to undergo an MRI scan.
I can speak and understand English or Spanish well enough for medical procedures.
My dementia is in the mild to moderate stage.
See 4 more

Exclusion Criteria

Exclusions specific to neuroimaging procedure: surgically implanted metallic devices such as aneurysm clips or pacemakers, large amounts of dental or surgical hardware in the head and neck, known history of claustrophobia, weight >350lbs, or waist circumference >55 inches
I have a history of head trauma, seizures, brain surgery, stroke, or cancer affecting my head.
My medical and mental health conditions are stable.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive remotely supervised active tDCS or sham tDCS stimulation over the dorsolateral prefrontal cortex for 30 minutes, 5 times per week for 6 months at home

6 months

Follow-up

Participants are monitored for durability of tDCS effects on cognitive performance and neuroplasticity

3 months

Treatment Details

Interventions

  • tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver active tDCS
  • tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver sham tDCS
Trial Overview The study tests a tDCS device delivering either active or sham (fake) stimulation to the brain's dorsolateral prefrontal cortex at home. It aims to see if this treatment improves cognitive performance and symptoms over six months and affects neuroplasticity markers in patients with Alzheimer's.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCSExperimental Treatment1 Intervention
The active tDCS will involve 30-minutes of direct current at intensity of 2 milliamperes (mA).
Group II: Sham tDCSPlacebo Group1 Intervention
Sham stimulation consists of the direct current ramped up to 2mA over 30 seconds, ramped down over 30 seconds and stay at 0 current for the remaining application period.

tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver active tDCS is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as tDCS for:
  • Investigational use for cognitive enhancement in Alzheimer's disease
🇪🇺
Approved in European Union as tDCS for:
  • Investigational use for cognitive enhancement in Alzheimer's disease

Find a Clinic Near You

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials
302
Recruited
11,690,000+

Stony Brook University

Collaborator

Trials
225
Recruited
41,700+

MJHS Institute for Innovation in Palliative Care

Collaborator

Trials
6
Recruited
1,700+

Findings from Research

In a study involving 50 participants, the effects of different tDCS devices and electrode sizes on quadriceps motor cortical excitability were evaluated, and no significant differences were found, suggesting that these factors do not impact the effectiveness of tDCS.
The results indicated that anodal tDCS did not significantly alter motor cortical excitability, leading to the conclusion that future research should focus on whether behavioral outcomes vary with different tDCS devices or electrode sizes.
Effect of conventional transcranial direct current stimulation devices and electrode sizes on motor cortical excitability of the quadriceps muscle.Gardi, AZ., Vogel, AK., Dharia, AK., et al.[2022]
A review of 15 studies on transcranial direct current stimulation (tDCS) before 1998 found that most trials (about 83%) focused on treating psychiatric conditions like depression and schizophrenia, with 12 out of 15 studies showing positive outcomes.
While the stimulation intensities used in older studies were lower than modern standards, the longer session durations and higher current densities suggest that these factors may have contributed to the encouraging results and mild side effects reported, such as headaches.
Notes on Human Trials of Transcranial Direct Current Stimulation between 1960 and 1998.Esmaeilpour, Z., Schestatsky, P., Bikson, M., et al.[2022]
In a clinical trial involving 16 participants with moderate-to-severe major depression, transcranial direct current stimulation (tDCS) led to a significant reduction in depressive symptoms within just two weeks of treatment, as measured by the Montgomery-Åsberg Depression Rating Scale.
By the end of the treatment and tapering phase, 75% of participants responded positively to the tDCS intervention, with 63% achieving remission, indicating that tDCS can be an effective option for managing major depression.
Home-administered transcranial direct current stimulation is a feasible intervention for depression: an observational cohort study.Charvet, L., George, A., Charlson, E., et al.[2023]

References

Effect of conventional transcranial direct current stimulation devices and electrode sizes on motor cortical excitability of the quadriceps muscle. [2022]
Notes on Human Trials of Transcranial Direct Current Stimulation between 1960 and 1998. [2022]
Home-administered transcranial direct current stimulation is a feasible intervention for depression: an observational cohort study. [2023]
Physics of Transcranial Direct Current Stimulation Devices and Their History. [2022]
Optimized high-definition tDCS in patients with skull defects and skull plates. [2023]
Safety of transcranial direct current stimulation in healthy participants. [2021]
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]
Differences in the experience of active and sham transcranial direct current stimulation. [2021]
A safety study of 500 μA cathodal transcranial direct current stimulation in rat. [2020]
10.Korea (South)pubmed.ncbi.nlm.nih.gov
Potential of Transcranial Direct Current Stimulation in Alzheimer's Disease: Optimizing Trials Toward Clinical Use. [2022]
Behavioural and electrophysiological modulations induced by transcranial direct current stimulation in healthy elderly and Alzheimer's disease patients: A pilot study. [2020]
Neurostimulation for cognitive enhancement in Alzheimer's disease (the NICE-AD study): a randomized clinical trial. [2022]
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