Transcranial Electrical Stimulation for Mild Cognitive Impairment

Recruiting at 1 trial location

Overseen By Phan Luu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brain Electrophysiology Laboratory Company

Must not be taking: EEG affecting drugs

Disqualifiers: Seizures, Epilepsy, Brain injury, others

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

Compensation: Varies

Number of Visits: 3

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called SleepWISP, which uses gentle electrical currents to potentially enhance deep sleep and improve memory in individuals with mild cognitive impairment (MCI). Researchers aim to determine if this device can boost deep sleep both in a single night and over several nights. They are also investigating its effects on memory and any potential links to Alzheimer's disease. Individuals with mild memory issues or without such issues may qualify, provided they do not have conditions like epilepsy or severe insomnia. Participants will wear a comfortable device during sleep and provide blood or nasal samples to aid in gathering insights. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve sleep and memory.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those on medications that may affect the EEG (a test that measures brain activity). It's best to discuss your specific medications with the trial team.

What prior data suggests that the SleepWISP device is safe for enhancing deep sleep?

Research shows that non-invasive transcranial electrical stimulation (TES), such as the treatment used in SleepWISP, is generally well-tolerated. In past studies, participants using similar brain stimulation methods reported only minor side effects, most often experiencing mild sensations like tingling or itching at the electrode sites.

Another study examined the safety of similar electrical brain stimulation in older adults with mild memory problems. The results indicated that the treatment was safe and practical, with no major negative effects reported.

Overall, while the treatment aims to improve deep sleep and potentially enhance memory, current research suggests it is safe. Participants can feel confident about the low risk of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for mild cognitive impairment, which often involve medications or lifestyle changes, SleepWISP uses a unique approach called transcranial electrical stimulation (TES). This method delivers a gentle electrical current to specific areas of the brain, aiming to enhance deep sleep. Researchers are excited because deep sleep is crucial for memory consolidation and cognitive function, offering a potential new way to address cognitive decline. This non-invasive technique could provide an alternative for those seeking non-drug interventions, improving brain health by targeting sleep quality directly.

What evidence suggests that the SleepWISP device is effective for enhancing deep sleep in people with mild cognitive impairment?

Research has shown that transcranial electrical stimulation (TES) can improve thinking skills like memory and learning in healthy individuals. TES sends gentle electrical currents to specific brain areas. Studies suggest that this enhances brain activity during sleep, leading to better cognitive performance. Evidence indicates that non-invasive methods like TES can significantly boost memory in individuals with mild cognitive impairment. In this trial, participants will use the SleepWISP device for deep sleep enhancement with TES. Although specific data on SleepWISP remains limited, the overall effectiveness of TES in enhancing cognitive functions appears promising. Early findings suggest that using TES to improve deep sleep could lead to better memory. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 40-80 without MCI and those aged 55-85 with Amnestic MCI. It's not suitable for individuals on certain medications, with allergies to lidocaine or silver, history of seizures or ECT, severe insomnia or sleep apnea, severe anxiety or depression, metal in the head, pregnancy, adverse reaction to TMS, brain injury/trauma, significant neurological diseases like Parkinson's or stroke.

Inclusion Criteria

I am between 55 and 85 years old with Amnestic MCI.

I am a healthy volunteer aged between 40 and 80.

Exclusion Criteria

I have had a brain injury or surgery in the past.

I have had a stroke in the past.

I have undergone Electroconvulsive Therapy (ECT).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I: Baseline and Acclimation

Participants use the Sleep WISP device to passively record sleep EEG without TES as baseline, followed by a randomized experiment condition (placebo or active TES) and a final session with the opposite condition.

2 weeks

3 visits (in-person)

Phase II: Repeated-Measures Placebo-Controlled

Participants wear the WISP device for 2 weeks with either sham or treatment TES, followed by a 2-week washout period, and then receive the remaining condition for the last 2 weeks.

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including memory performance and biomarker analysis.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SleepWISP

Trial Overview

The study tests if a home-use device called SleepWISP can improve deep sleep and memory in people with mild cognitive impairment using transcranial electrical stimulation (TES). Participants will wear devices that monitor brain activity during sleep and an actigraphy watch by day. Blood samples will also be collected.

How Is the Trial Designed?

Group I: Deep Sleep Enhancement with TES Experimental Treatment 1 Intervention

Transcranial Electrical Stimulation, 0.5 Hz sine wave, 0.5 mA, between frontal (frontopolar and inferior lateral frontal) and posterior (mastoid and occipital) electrodes.

Who Is Running the Clinical Trial?

Brain Electrophysiology Laboratory Company

Lead Sponsor

Trials

4

Recruited

130+

Wake Forest University

Collaborator

Trials

193

Recruited

151,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Low intensity transcranial electrical stimulation (TES) is considered safe, with no serious adverse events reported in over 18,000 sessions across various populations, including healthy individuals and patients with neurological or psychiatric conditions.

While moderate adverse events like skin burns from tDCS are rare, mild adverse events such as headaches and fatigue are more common, and the safety profile is consistent across different age groups and vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Antal, A., Alekseichuk, I., Bikson, M., et al.[2023]

Acoustic stimulation during sleep significantly increased slow-wave activity (SWA) by over 10% in individuals with amnestic mild cognitive impairment (aMCI), indicating its potential to enhance sleep quality.

While the increase in SWA was associated with improved memory recall in some participants, consistent memory improvement may require longer or more intense stimulation, as only five out of nine patients showed enhanced recall after stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acoustic enhancement of sleep slow oscillations in mild cognitive impairment. Papalambros, NA., Weintraub, S., Chen, T., et al.[2023]

Transcranial Electrical Stimulation (TES) targeting anterior limbic areas significantly increased the duration of deep sleep (N3) in 13 healthy adults, suggesting a potential method to enhance sleep quality.

The study also found that TES increased spectral power in specific brain regions, indicating that this stimulation may improve neurological health and memory, which could be beneficial for individuals at risk of Alzheimer's Disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Electrical Stimulation targeting limbic cortex increases the duration of human deep sleep. Hathaway, E., Morgan, K., Carson, M., et al.[2021]

In a study involving 16 patients with mild cognitive impairment (MCI), slow oscillatory transcranial direct current stimulation (so-tDCS) applied during daytime naps significantly enhanced sleep-related brain activity, specifically increasing slow oscillations and spindle power, which are important for memory formation.

The so-tDCS not only improved the synchronization of these brain activities but also led to better visual declarative memory performance compared to sham stimulation, suggesting a promising noninvasive approach to address sleep and memory issues in early Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Sleep Oscillations and Their Functional Coupling by Transcranial Stimulation Enhances Memory Consolidation in Mild Cognitive Impairment. Ladenbauer, J., Ladenbauer, J., Külzow, N., et al.[2020]

Transcranial electrical stimulation (tES), including tDCS and MHF-tPCS, was found to be well tolerated in healthy subjects over a six-week period, with common side effects being mild skin sensations like tingling and itching, which were less frequent than in the sham-tDCS group.

The MHF-tPCS group showed significantly higher compliance in completing sessions compared to the sham-tDCS group, indicating that this waveform may be more acceptable for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability of Repeated Application of Transcranial Electrical Stimulation with Limited Outputs to Healthy Subjects. Paneri, B., Adair, D., Thomas, C., et al.[2018]

Transcranial Electrical Stimulation (tES) has been shown to modify brain oscillations during sleep, indicating its potential as a non-invasive tool for sleep modulation.

While the effects of tES on objective sleep patterns are inconsistent, subjective assessments of sleep quality consistently show improvements, suggesting that tES may enhance perceived sleep quality in both healthy individuals and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Transcranial Electrical Stimulation of the Brain on Sleep: A Systematic Review. Dondé, C., Brunelin, J., Micoulaud-Franchi, JA., et al.[2021]

Short duration repetitive transcranial electrical stimulation (SDR-tES) during daytime naps significantly enhances declarative memory consolidation in healthy individuals, showing improved memory performance compared to sham stimulation both immediately after sleep and 48 hours later.

SDR-tES also increases the amount of time spent in deeper NREM sleep (NREM3) and boosts the rate of slow oscillations during NREM sleep, suggesting that the timing of stimulation during quiet brain activity may optimize its effects on memory consolidation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short Duration Repetitive Transcranial Electrical Stimulation During Sleep Enhances Declarative Memory of Facts. Cellini, N., Shimizu, RE., Connolly, PM., et al.[2023]

Low-intensity transcranial electric stimulation (tES) is considered safe when following established protocols and using devices that adhere to engineering risk-management standards, but outcomes can vary significantly based on numerous factors such as dosage and individual characteristics.

Self-administered brain stimulation devices must be designed to minimize variability in efficacy and should not make medical claims, as they are less regulated than medical devices, highlighting the importance of ethical marketing practices by manufacturers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive brain stimulation and neuroenhancement. Antal, A., Luber, B., Brem, AK., et al.[2022]

Limited output transcranial electrical stimulation (tES) devices, such as tDCS, tACS, and tPCS, have been shown to have electrical output levels significantly lower than many FDA-cleared devices, suggesting they pose minimal risk when responsibly manufactured and marketed.

The paper establishes a comprehensive framework for the regulation and manufacturing standards of low-power tES devices, promoting safety and innovation while ensuring public access to these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limited output transcranial electrical stimulation (LOTES-2017): Engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk. Bikson, M., Paneri, B., Mourdoukoutas, A., et al.[2018]

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