Brain Stimulation for Memory Impairments in Epilepsy

(MEMREINS Trial)

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

800 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to understand biomarkers of human memory through correlational analyses and to use focal electrical stimulation as a causal manipulation to understand how biomarkers of memory relate to other brain states and behavioral measures.

Research Team

Michael Kahana, PhD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+