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Neurostimulation for Epilepsy

N/A
Waitlist Available
Led By Robert Gross, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, aged 18-65
Diagnosed with lesional or non-lesional mesial temporal (hippocampal) seizure onset confirmed on SEEG monitoring
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 6 weeks postintervention
Awards & highlights

Study Summary

This trial will study individuals with medical temporal lobe epilepsy who are having surgery to determine if computerized memory tasks and stimulation can help with their condition.

Who is the study for?
This trial is for adults aged 18-65 with mesial temporal lobe epilepsy, confirmed by SEEG monitoring. Participants must have depth electrodes implanted for seizure localization and be able to give informed consent. Pregnant women, minors, and incarcerated individuals cannot participate.Check my eligibility
What is being tested?
The study tests ADMES using an implantable neurostimulation device in patients with mesial temporal lobe epilepsy during their surgical workup. It involves computerized memory tasks paired with stimulation while under intracranial EEG monitoring.See study design
What are the potential side effects?
Potential side effects of the ADMES neurostimulation may include discomfort at the electrode site, temporary worsening of seizures, headaches or dizziness post-stimulation, and possible skin irritation from the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are between 18 and 65 years old.
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You have been diagnosed with seizures starting in the middle of the brain near the hippocampus.
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You have had depth electrodes implanted to find the source of your seizures, and have multiple electrode arrays in your hippocampus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 6 weeks postintervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 6 weeks postintervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Intracranial EEG Recording: Spectral Power From Baseline
Change in Intracranial EEG Recording: Synchrony From Baseline
Secondary outcome measures
Changes in Memory During Brain Stimulation From Baseline

Trial Design

1Treatment groups
Experimental Treatment
Group I: Brain stimulation via clinically implanted electrodesExperimental Treatment1 Intervention
Brain will be stimulated in different patterns including synchronized or asynchronous current.

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,627 Previous Clinical Trials
2,560,764 Total Patients Enrolled
Robert Gross, MDPrincipal InvestigatorEmory University
3 Previous Clinical Trials
1,048 Total Patients Enrolled

Media Library

Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device Clinical Trial Eligibility Overview. Trial Name: NCT04710004 — N/A
Mesial Temporal Lobe Epilepsy Research Study Groups: Brain stimulation via clinically implanted electrodes
Mesial Temporal Lobe Epilepsy Clinical Trial 2023: Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device Highlights & Side Effects. Trial Name: NCT04710004 — N/A
Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device 2023 Treatment Timeline for Medical Study. Trial Name: NCT04710004 — N/A

Frequently Asked Questions

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

Who would meet the eligibility criteria to participate in this trial?

"This research is looking for 18 participants with epilepsy, between ages of majority and retirement age. Patients must meet the following criteria: Confirmation that their mesial temporal (hippocampal) seizure onset was detected during SEEG monitoring; have electrodes implanted on multiple hippocampal arrays to localize seizure origin; provide a signed and dated informed consent form; identify as male or female in this demographic range."

Answered by AI

How many study participants are being monitored as part of this clinical research?

"Absolutely. The information present on clinicaltrials.gov shows that this study is actively seeking participants; it was initiated on November 30th 2021 and amended as recently as March 2nd 2022. This medical research requires 18 subjects from a single medical facility to take part in the trial."

Answered by AI

Is this research endeavor currently recruiting participants?

"Correct. Clinicaltrials.gov records demonstrate that this health research endeavour, which was initially published on November 30th 2021, is actively recruiting volunteers. The trial hopes to enroll 18 patients from a single location."

Answered by AI

Are geriatric patients being included in the sample population for this exploration?

"This trial is restricted to participants aged 18-65; those that don't qualify are encouraged to look into the 103 studies for minors or the 157 trials for seniors."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
What portion of applicants met pre-screening criteria?
Met criteria
~0 spots leftby Mar 2025