Brain Stimulation for Memory Impairments in Epilepsy

(MEMREINS Trial)

Not currently recruiting at 11 trial locations

Overseen By Michael Sperling, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Physical disability, Cognitive disability, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore memory function in people with epilepsy through direct electrical brain stimulation. Researchers seek to understand the connection between memory markers and other brain activities or behaviors. The study involves administering small, controlled electrical pulses to the brain and comparing the effects to no stimulation. Individuals with epilepsy that does not improve with medication and who are scheduled for brain monitoring may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on epilepsy and memory.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this direct electrical stimulation is safe for memory impairments in epilepsy?

Research suggests that electrical brain stimulation can be safe in some cases. For example, one study found that stimulating the nucleus accumbens was safe for people with epilepsy. Although this isn't the exact type of stimulation used in the trial, it provides insights into safety.

It's important to know that the FDA has not approved this kind of brain stimulation for any health condition yet. This means it is still under study to ensure its effectiveness and safety.

In summary, while some studies indicate that electrical stimulation can be safe, more research is needed to confirm this, especially for memory-related issues in epilepsy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Direct electrical stimulation is unique because it directly targets brain areas to improve memory in epilepsy patients, unlike traditional treatments that often involve medication to manage seizures. This technique delivers targeted electrical impulses to the brain, potentially enhancing cognitive function during tasks. Researchers are excited about this approach as it offers a non-invasive alternative with the potential for more precise effects on memory, possibly leading to fewer side effects compared to medication.

What evidence suggests that direct electrical stimulation is effective for memory impairments in epilepsy?

Research has shown that electrical stimulation, such as direct electrical stimulation, can improve memory and thinking skills in people with epilepsy. In this trial, participants will receive direct electrical stimulation during tasks. One study found that deep brain stimulation (DBS) not only helps control seizures but also enhances memory and other cognitive functions. Another review suggests that DBS can boost memory and thinking abilities in conditions like Alzheimer's and Parkinson's, indicating it might also help with epilepsy. Additionally, some patients who received certain types of brain stimulation reported better verbal skills. These findings suggest that direct electrical stimulation may help with memory problems related to epilepsy. ^{4 6 7 8 9}

Who Is on the Research Team?

Michael Kahana, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for individuals with drug-resistant epilepsy who are already scheduled to have brain monitoring. Participants should be able to perform memory tests and give informed consent. It's not suitable for those with cognitive or physical disabilities affecting task performance, psychiatric conditions impacting consent, other serious medical issues, or pregnant women.

Inclusion Criteria

I am scheduled for brain monitoring due to hard-to-treat epilepsy.

Exclusion Criteria

Pregnancy

Medical condition limiting subject's participation in the study

You have a mental health condition that makes it hard for you to understand the study or complete tasks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive direct electrical stimulation to study memory biomarkers, interleaved with sham trials

4 weeks

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Direct electrical stimulation

Trial Overview The study uses direct electrical brain stimulation during verbal and spatial memory tasks to understand how the brain processes memories. This research involves multiple sites working together and participants will undergo experiments while being monitored.

How Is the Trial Designed?

Group I: Direct Electrical Stimulation Experimental Treatment 1 Intervention

Stimulation will be applied concurrently with the task, if applicable, and stimulation trials will be interleaved with sham trials, where no stimulation is delivered.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

University of Freiburg

Collaborator

Trials

57

Recruited

24,600+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

Thomas Jefferson University

Collaborator

Trials

475

Recruited

189,000+

The University of Texas Health Science Center at San Antonio

Collaborator

Trials

486

Recruited

92,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11586187/

Transcranial direct current stimulation in the management ... Our results indicated that tDCS reduced seizure frequency by ~28 and 49% within 1- and 2-month follow-ups post-treatment, respectively. Further ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0361923024002685

Review Deep brain stimulation on cognition in epilepsy Recently data suggests that DBS can not only improve the seizure control, but also improved cognitive function. This review summarizes the effects of DBS on ...

3. nature.com nature.com/articles/s41593-025-01988-1

Closed-loop electrical stimulation prevents focal epilepsy ... It is unclear whether addressing IED-induced dysfunction could improve epilepsy outcomes, as most therapeutic approaches target seizures.

4. seizure-journal.com seizure-journal.com/article/S1059-1311(11)00300-1/fulltext

Cognitive improvement after long-term electrical ... The mean seizure-reduction rate of these patients after ATN DBS was 57.9% (35.6–90.4%). Cognitive testing showed favorable results for verbal fluency tasks ( ...

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

Effect of neurostimulation on cognition and mood in ... DBS may be effective in treating disorders of memory and cognition, like Alzheimer's and Parkinson's disease,40 and so DBS for epilepsy may be associated with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5007190/

Safety of transcranial Direct Current Stimulation: Evidence ... This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0965229925000172

The safety and effectiveness of tDCS for epileptic patients The current evidence is limited to support tDCS treatment for depression, anxiety, and cognitive function in epilepsy patients.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4119256/

Safety and feasibility of nucleus accumbens stimulation in five ... We provide initial evidence for safety and feasibility of chronic electrical stimulation of the NAC in patients with intractable partial epilepsy.

9. health.harvard.edu health.harvard.edu/blog/can-electrical-brain-stimulation-boost-attention-memory-and-more-202303032898

Can electrical brain stimulation boost attention, memory ... The FDA has not cleared tDCS for any health condition, and it is considered investigational. More research with positive results and reassuring ...