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Intracranial Stimulation for Memory Enhancement

N/A

Recruiting

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with epilepsy.

Diagnosed with epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial will study how the amygdala affects other structures in the brain to better understand how memories are stored. This is relevant to disorders where memory and emotion are affected, such as traumatic brain injury and post-traumatic stress disorder.

Who is the study for?

This trial is for English-speaking individuals who can consent to participate, have been diagnosed with epilepsy, and are scheduled for long-term video monitoring of seizures. They must be set to receive intracranial depth electrodes in specific brain regions related to memory.Check my eligibility

What is being tested?

The study is testing the effects of stimulating the amygdala—a part of the brain—on memory functions. It aims to improve understanding relevant to conditions like traumatic brain injury and post-traumatic stress disorder that affect memory.See study design

What are the potential side effects?

While not explicitly stated, potential side effects may include discomfort at electrode sites, headaches, or changes in mood or cognition due to stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with epilepsy.

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I have been diagnosed with epilepsy.

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I am scheduled for a long-term brain video monitoring to locate my seizure origins.

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I have electrodes implanted in specific parts of my brain.

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I have electrodes implanted in specific brain areas for monitoring.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Free recall memory discriminability index (proportion recalled)

Recognition memory discriminability index (proportion recalled)

Secondary outcome measures

Amplitude of SPEP response to amygdala stimulation

LFP of bad memory state

Latency of SPEP response to amygdala stimulation

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Brain StimulationExperimental Treatment1 Intervention

Neurosurgical epilepsy patients that undergo placement of medial temporal electrode for seizure localizations will be recruited. All participants will view a series of images of emotionally-neutral objects on a computer screen. After each item presentation, they will randomly undergo either active-BLAES or sham-stimulation. Over subsequent days, free recall and recognition memory for these items, relative to new distractor items will be tested. Memory for items presented with and without stimulation will be compared. Brain activity recorded in the medial temporal lobe during item presentations will be used to predict subsequent memory. Such good and bad memory states (biomarkers) will be used to perform closed-loop stimulation when bad memory states are detected in order to enhance subsequent memory.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,720 Total Patients Enrolled

Media Library

Intracranial Stimulation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05065450 — N/A

Memory Loss Research Study Groups: Brain Stimulation

Memory Loss Clinical Trial 2023: Intracranial Stimulation Highlights & Side Effects. Trial Name: NCT05065450 — N/A

Intracranial Stimulation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05065450 — N/A

Memory Loss Patient Testimony for trial: Trial Name: NCT05065450 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there presently any opportunities to join the experiment?

"The evidence on clinicaltrials.gov illustrates that this research study is currently in the recruitment phase. The trial was originally listed on November 1st 2021 with its most recent update appearing on November 29th of the same year."

Answered by AI

Does this experiment cater to individuals aged 45 or more?

"The study's regulations stipulate that the minimum age for participation is 18, while the maximum age limit stands at 75."

Answered by AI

What key goals are being sought out in this medical investigation?

"The primary metric of this five-year long clinical trial is the Free Recall Memory Discriminability Index (proportion recalled). Secondary objectives include recording Location of Single Pulse Evoked Potential responses to Amygdala Stimulation, Local Field Potentials indicative of a Good Memory State, and Latency of SPEP Responses."

Answered by AI

What is the current participant recruitment for this trial?

"Affirmative. According to clinicaltrials.gov, this medical trial is actively enrolling applicants since its inception on November 1st 2021 and continues to be updated as late as November 29th 2021. They are hoping for 90 participants from a single site."

Answered by AI

Is there any possibility of me joining this experiment?

"This investigation requires 90 participants aged 18-75 with aura to take part. Furthermore, these individuals must also possess certain prerequisites in order for their participation: implantation of intracranial depth electrodes into the amygdala, hippocampus, and parahippocampal/perirhinal cortices plus scheduled long-term intra-cranial video monitoring for seizure onset localization."

Answered by AI

Who else is applying?

What state do they live in?

Illinois

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

What site did they apply to?

Washington University School of Medicine

Why did patients apply to this trial?

I have been on over 4 different medications and was told at this point my memory loss will never improve.

PatientReceived 1 prior treatment

I reside with other seniors in independent living apts. for 6 plus years. I can see others decline. I do not want to give up on myself. I have seen a neurologist Dr Santwani and he found some brain seizures while sleeping during study. I read and interpret other things in my own life.

PatientReceived no prior treatments

Recent research and studies

Proceedings of the National Academy of SciencesJournal

Direct Electrical Stimulation of the Amygdala Enhances Declarative Memory in Humans

Inman, Cory S., Joseph R. Manns, Kelly R. Bijanki, David I. Bass, Stephan Hamann, Daniel L. Drane, Rebecca E. Fasano, Christopher K. Kovach, Robert E. Gross, and Jon T. Willie. 2017. “Direct Electrical Stimulation of the Amygdala Enhances Declarative Memory in Humans”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.1714058114.

Behavioral NeuroscienceJournal

Memory-enhancing Amygdala Stimulation Elicits Gamma Synchrony in the Hippocampus.

Bass, David I., and Joseph R. Manns. 2015. “Memory-enhancing Amygdala Stimulation Elicits Gamma Synchrony in the Hippocampus.”. Behavioral Neuroscience. American Psychological Association (APA). doi:10.1037/bne0000052.

Current Directions in Psychological ScienceJournal

The Amygdala and Prioritization of Declarative Memories

Manns, Joseph R., and David I. Bass. 2016. “The Amygdala and Prioritization of Declarative Memories”. Current Directions in Psychological Science. SAGE Publications. doi:10.1177/0963721416654456.

Neurobiology of Learning and MemoryJournal