Brain Stimulation for Cognitive Impairment

Overseen By Ishita Basu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Cognitive impairments, Physical impairments, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: up to 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how brain stimulation, a technique involving electrical stimulation, might affect cognitive control, which refers to how brains manage tasks and focus attention. Participants will receive targeted electrical stimulation to specific brain areas while researchers record brain activity. The goal is not to treat a disease but to better understand brain function. Ideal candidates are adults already undergoing EEG (brain activity monitoring) for epilepsy treatment at the University of Cincinnati Medical Center. As an unphased study, this trial offers participants a unique opportunity to contribute to groundbreaking research on brain function.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Since the study involves patients already undergoing treatment for epilepsy, it's likely you can continue your current medications, but you should confirm with the study team.

What prior data suggests that this brain stimulation is safe for cognitive impairment studies?

Research has shown that brain stimulation is safe for people with epilepsy. Studies have found that different types, such as deep brain stimulation (DBS) and responsive neurostimulation (RNS), are generally well-tolerated. These treatments have helped reduce seizures and have been considered safe over many years.

In this study, participants will receive brief electrical brain stimulation. Researchers carefully select the settings to ensure safety, testing them first to avoid any discomfort or distress. This design prioritizes participant safety. However, as a basic neuroscience study, the focus is more on understanding brain activity than on treating any condition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about brain stimulation for cognitive impairment because it offers a novel approach by directly interacting with brain activity. Unlike traditional treatments that primarily focus on medication or therapy, electrical brain stimulation tailors the intervention to each individual's brain activity in real-time. This method could potentially enhance cognitive functions by targeting specific brain regions without the risks associated with medication side effects. Additionally, the stimulation parameters are personalized and kept within safe limits, ensuring a comfortable experience for participants.

What evidence suggests that brain stimulation is effective for cognitive impairment?

Research has shown that brain stimulation, such as vagus nerve stimulation (VNS), can help maintain thinking skills in people with epilepsy. Studies have found that treatments like VNS and deep brain stimulation (DBS) reduce seizures. These treatments also link to stable or improved thinking and mood. While the immediate effects on cognition remain unclear, long-term results appear promising for mental health maintenance. In this trial, participants will receive electrical brain stimulation, which might aid in thinking control, even for those with epilepsy. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This study is for adult patients at the University of Cincinnati Medical Center who are already getting EEG monitoring for epilepsy treatment and can consent to participate. It excludes minors, those with cognitive or physical impairments affecting test participation, non-English speakers, pregnant women, and prisoners.

Inclusion Criteria

I am an adult with drug-resistant epilepsy and am getting EEG monitoring at the University of Cincinnati Medical Center.

Exclusion Criteria

I am unable to give consent for medical procedures.

Pregnant women (note: pregnant women are not candidates for intracranial EEG monitoring)

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo brain recording and electrical stimulation while performing cognitive tasks

up to 1 week

Continuous monitoring during task performance

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brain Stimulation

Trial Overview The study involves brain stimulation while recording EEG in participants. It aims to understand how stimulating certain brain areas affects cognitive control but isn't designed as a treatment trial for any condition.

How Is the Trial Designed?

Group I: Electrical stimulation Experimental Treatment 1 Intervention

Participants will receive brief electrical brain stimulation as they perform the study tasks. This will be linked to events occurring on screen and/or to specific changes in their brain activity. The stimulation parameters will be individualized for each participant, but will never exceed safe limits for charge density (30 µC/phase). They will always be tested beforehand to ensure that they do not cause participants any discomfort or distress.

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33711711/

Cognitive outcomes following vagus nerve stimulation ... Long-term cognitive outcomes are at least stable following VNS, DBS and RNS. Acute effects of stimulation are less clear.

2. sciencedirect.com sciencedirect.com/science/article/pii/S187874792301944X

Neurostimulation treatments for epilepsy: Deep brain ... E03 and E05 are two of the largest multicenter, randomized studies on VNS outcomes [26,27]. Both demonstrate the efficacy of high-intensity VNS in reducing ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/epi.18544

A systematic review and meta‐analysis of vagus nerve ... This meta-analysis suggests that all three neuromodulation therapies are effective for seizure reduction in LGS, with DBS and RNS demonstrating potentially ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0920121121000449

Cognitive outcomes following vagus nerve stimulation ... Long-term cognitive outcomes are at least stable following VNS, DBS and RNS. Acute effects of stimulation are less clear. However, data are limited by number, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5839311/

Effect of neurostimulation on cognition and mood in ... Here, we review the current evidence for how invasive and noninvasive neurostimulation therapies affect mood and cognition in persons with epilepsy.

6. neurology.org neurology.org/doi/10.1212/WNL.0000000000010154

Nine-year prospective efficacy and safety of brain- ... This study provides Class IV evidence that brain-responsive neurostimulation significantly reduces focal seizures with acceptable safety over 9 years.