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Clinical Trials/NCT04286776
NCT04286776
Active, not recruiting
Not Applicable

Memory Retrieval and Encoding Investigated by Neural Stimulation

University of Pennsylvania11 sites in 1 country800 target enrollmentOctober 12, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy Intractable
Sponsor
University of Pennsylvania
Enrollment
800
Locations
11
Primary Endpoint
To determine whether state-dependent stimulation can separately be used to modulate encoding and retrieval processes
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 12, 2014
End Date
December 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Expected to undergo intracranial implantation and postoperative electroencephalographic monitoring as part of a standard clinical procedure for the treatment of pharmacologically resistant epilepsy
  • Age 18 or older

Exclusion Criteria

  • Any physical or cognitive disability or illness that would limit their ability to perform cognitive tasks
  • Any medical condition that would, in the investigator's opinion, limit the subject's participation in the study.
  • Unable or unwilling to provide informed consent
  • MRI contraindications
  • Standard clinical care includes a pregnancy test for female patients prior to the surgical implantation of the electrodes. Pregnant women are not surgically implanted.

Outcomes

Primary Outcomes

To determine whether state-dependent stimulation can separately be used to modulate encoding and retrieval processes

Time Frame: Up to 4 weeks (typical duration of hospital stay)

4. We will evaluate the closed-loop stimulation protocol described in Kahana et al. (2023) in both encoding and retrieval.

To determine whether stimulation is more effective at modulating memory when targeted to regions with specific connectivity profiles to the medial temporal lobe

Time Frame: Up to 4 weeks (typical duration of hospital stay)

5. We will compare recall rates during a free recall experiment with brain stimulation at sites with high network-mediated activation, as described in Solomon et al. (2018), versus low network-mediated activation.

To determine how simultaneous stimulation at multiple target sites can be optimized to modulate memory

Time Frame: Up to 4 weeks (typical duration of hospital stay)

6. We will compare recall rates during a free recall experiment with no brain stimulation, stimulation at one site, and stimulation at multiple sites.

To use direct electrical stimulation to disentangle causal versus correlative biomarkers of verbal and spatial episodic memory

Time Frame: Up to 4 weeks (typical duration of hospital stay)

1. We will use linear mixed effects models and L2-penalized logistic regression classifiers to compare periods of successful and unsuccessful performance in our tasks

To develop and test models of human brain dynamics in the presence of electrical stimulation

Time Frame: Up to 4 weeks (typical duration of hospital stay)

2. We will compare spectral indices of brain activity before and after stimulation as a function of stimulation parameters.

To assess how reactivation of prior memories shapes subsequent recall and memory organization, including memory for the content, context and value of experiences.

Time Frame: Up to 4 weeks (typical duration of hospital stay)

3. We will mathematical models of neural similarity described in detail in Halpern (2024) and Manning (2011, 2012) to test the reactivation mechanisms described in Lohnas et al. (2014) and Healey and Kahana (2015).

Study Sites (11)

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