Hippocampal Network Function in Epilepsy

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT06521437
Status
Enrolling By Invitation

Conditions

  • Mesial Temporal Lobe Epilepsy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Jul 1, 2024
Status verified
Sep 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Experiment 1
    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

Primary Outcome Measure

Epileptic activity (IEDs) [ Time Frame: Measured at baseline and 1 day after stimulation ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637-

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By research site
University of Chicago· Chicago, IL

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