Hippocampal Network Function in Epilepsy

NCT06521437 | Enrolling By Invitation FDA Device

• 1 other identifier: IRB23-1089
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this pilot study is to understand hippocampal network function in mesial temporal lobe epilepsy (MTLE) and to test whether transcranial magnetic stimulation (TMS) targeting the network of the hippocampus can change hippocampal-dependent memory task performance and epileptic activity in people with (MTLE). Positive findings would implicate the hippocampal network as a source of these typical primary MTLE symptoms. Subjects with a primary diagnosis of MTLE will be enrolled in a non-randomized, non-blinded pilot experiment to test target engagement and preliminary efficacy of a novel neurostimulation approach targeting the hippocampal network. At baseline, subjects will undergo neurocognitive testing for hippocampal-dependent memory and functional magnetic resonance imagining (fMRI) neuroimaging assessment of brain structure and task-dependent activity. They will also receive scalp-electroencephalography (EEG) to measure interictal epileptiform discharge (IED) frequency at baseline, and will complete a seizure diary for one month. They will then receive high-frequency repetitive TMS targeting an area of parieto-occipital cortex defined based on fMRI connectivity with the hippocampus measured at baseline. The baseline assessments will then be repeated, using an alternate form of the memory test. The investigators will analyze changes from baseline in memory task performance, fMRI activity of the hippocampal network, IED frequency, and reported seizure frequency.

Conditions

Mesial Temporal Lobe Epilepsy

Outcome Measures

Primary Outcomes (1)

• Epileptic activity (IEDs)

  Scalp EEG is used to measure IEDs, identified via clinical assessment and quantified

  Measured at baseline and 1 day after stimulation

Secondary Outcomes (3)

• Memory task performance

  The memory task is administered at baseline and 1 day after the last stimulation session. Recall will be measured approximately 15 minutes after seeing the word pairs.

• fMRI connectivity of the hippocampal network

  First day of study (baseline session) and 1 day after last stimulation session.

• Seizure frequency reported in seizure diary

  From the baseline session to 30 days following the post-treatment sessions

Study Arms (1)

Experiment 1

EXPERIMENTAL

Subjects will be tested for baseline performance on a memory task while in an MRI scanner and with scalp EEG. Subjects will then receive multiple sessions, of repetitive transcranial magnetic stimulation. Post-treatment, baseline assessments will be repeated. Overall study period per subject: 2 months

Device: TMS targeting the hippocampus indirectly via its network

Interventions

TMS targeting the hippocampus indirectly via its network DEVICE

Subjects will receive high-frequency repetitive TMS to a parieto-occipital location defined in each subject based on high resting-state fMRI connectivity with the hippocampus at baseline

Experiment 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of (pharmacoresistant) MTLE
• Age 18+ years old
• Native English speakers
• Normal or corrected-to-normal near and far vision
• Stable antiepileptic drugs (AED) regimen (unchanged for at least 1 month)

You may not qualify if:

• Diagnosis of neurological illness other than MTLE
• Taking drugs that impair cognition other than anticonvulsive medication for the treatment of MTLE (e.g., antipsychotics or psychostimulants).
• Children under the age of 18 years

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

• Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.

  PMID: 19833552 BACKGROUND

Study Officials

• Joel Voss, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 26, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)