204 Participants Needed

Noninvasive Brain Stimulation for Alzheimer's Disease

RM
Overseen ByRobert M. G. Reinhart, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Boston University Charles River Campus
Must be taking: Cholinesterase inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial allows participants to continue taking certain medications, including antidepressants, Alzheimer's medications, and various heart and blood pressure medications. However, if you are on medications not listed, it's best to check with the trial coordinators.

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

Research suggests that transcranial direct current stimulation (tDCS), a noninvasive method of brain stimulation, may help improve cognitive function and slow cognitive decline in people with Alzheimer's disease. Studies have shown improvements in memory and cognitive stability, indicating potential benefits of this treatment.12345

Is noninvasive brain stimulation safe for humans?

Transcranial direct current stimulation (tDCS), including its high-definition version (HD-tDCS), is generally considered safe and well-tolerated for various neurological and psychiatric conditions, with any adverse effects being low and temporary.12678

How does noninvasive brain stimulation differ from other treatments for Alzheimer's disease?

Noninvasive brain stimulation, specifically transcranial direct current stimulation (tDCS), is unique because it uses a mild electrical current to stimulate the brain without the need for medication. This method is non-pharmacological, meaning it doesn't involve drugs, and it aims to improve cognitive function and delay cognitive decline in Alzheimer's patients.1291011

What is the purpose of this trial?

The investigators will evaluate the theory that Alzheimer's disease-related memory impairment derives from the inefficient orchestration of rhythmic activity at the level of large-scale cortical networks. The results as expected to elucidate AD-related pathophysiology and set groundwork for the development of drug-free interventions for improving memory in AD and related dementias.

Eligibility Criteria

This trial is for people aged 50-100 with Alzheimer's or mild cognitive impairment due to Alzheimer's, having certain memory performance scores. Healthy individuals can join if they meet specific cognitive norms. Participants must not have severe mental health issues, significant past brain conditions, or be on excluded medications.

Inclusion Criteria

Do you have a diagnosis of Mild Cognitive Impairment or Alzheimer's disease?

Exclusion Criteria

Have you ever had a diagnosis of epilepsy, or do you have current or past history of seizures?
Do you have a history of neurological problems such as stroke or head injury such as traumatic brain injury?
Do you have any skin sensitivity on your face or scalp (the study involves placing a fabric cap, several electrodes and some water-soluble gel at these sites)?
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low-intensity, high-definition, transcranial electrical current stimulation while performing computer-based tasks

1 year

Follow-up

Participants are monitored for memory performance and cognitive function after treatment

4 weeks

Treatment Details

Interventions

  • High definition transcranial electrical current stimulation
Trial Overview The study tests whether noninvasive brain stimulation using high definition transcranial electrical current can improve memory in those with Alzheimer's by affecting rhythmic activity in the brain. It aims to pave the way for drug-free treatments.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: active stimulationExperimental Treatment1 Intervention
Memory performance data is collected during active brain stimulation and reported 1 year later
Group II: sham stimulationPlacebo Group1 Intervention
Memory performance data is collected during sham brain stimulation and reported 1 year later

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials
125
Recruited
14,100+

Findings from Research

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.
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 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.
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]
In a study involving 34 Alzheimer's disease patients, both anodal and cathodal transcranial direct current stimulation (tDCS) significantly improved cognitive function as measured by the mini-mental state examination (MMSE) compared to sham stimulation.
tDCS also reduced the P300 latency, a measure associated with cognitive processing, indicating potential benefits in neurorehabilitation for Alzheimer's patients, although it did not affect motor cortex excitability.
A double-blind randomized clinical trial on the efficacy of cortical direct current stimulation for the treatment of Alzheimer's disease.Khedr, EM., Gamal, NF., El-Fetoh, NA., et al.[2022]

References

Potential of Transcranial Direct Current Stimulation in Alzheimer's Disease: Optimizing Trials Toward Clinical Use. [2022]
Transcranial Direct Current Stimulation Improves Cognitive Function in Mild to Moderate Alzheimer Disease: A Meta-Analysis. [2020]
A double-blind randomized clinical trial on the efficacy of cortical direct current stimulation for the treatment of Alzheimer's disease. [2022]
Transcranial direct current stimulation improves recognition memory in Alzheimer disease. [2022]
Can 8 months of daily tDCS application slow the cognitive decline in Alzheimer's disease? A case study. [2018]
Tolerability and blinding of high-definition transcranial direct current stimulation among older adults at intensities of up to 4 mA per electrode. [2023]
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]
Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]
Ameliorative Effects of Different Transcranial Electrical Stimulation Paradigms on the Novel Object Recognition Task in a Rat Model of Alzheimer Disease. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Efficacy and safety of simultaneous rTMS-tDCS over bilateral angular gyrus on neuropsychiatric symptoms in patients with moderate Alzheimer's disease: A prospective, randomized, sham-controlled pilot study. [2023]
Neurostimulation for cognitive enhancement in Alzheimer's disease (the NICE-AD study): a randomized clinical trial. [2022]
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