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Brain Stimulation

Thalamic Stimulation for Temporal Lobe Epilepsy (START Trial)

Q: What are the eligibility requirements for participation in this medical trial?

<p>Only individuals that meet the criteria of having <a href="https://www.withpower.com/clinical-trials/epilepsy">epilepsy</a>, uncinate and being between 18-75 years old are able to participate in this trial. This study is hoping to enroll up to 5 patients.</p>

N/A

Waitlist Available

Led By Gregory Worrell, MD, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Drug resistance to at least two antiseizure medications with adequate dose and duration

Age 18 to 75 years at time of consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 45 months

Awards & highlights

START Trial Summary

This trial is testing whether adding bilateral thalamic stimulation to existing responsive neurostimulation can help restore consciousness in people with temporal lobe epilepsy whose seizures cannot be controlled by other treatments.

Who is the study for?

This trial is for adults aged 18-75 with temporal lobe epilepsy not controlled by medication, surgery, or other neurostimulation. Candidates must have a history of mesial temporal seizures, be drug-resistant to at least two antiseizure medications, and be medically stable. They should also be able to complete neuropsychology evaluations and manage the stimulation device.Check my eligibility

What is being tested?

The study tests whether central thalamic stimulation can restore consciousness during seizures in patients with temporal lobe epilepsy when other treatments fail. It's an innovative approach that differs from previous methods which focus on stopping seizures altogether.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort or risks associated with brain stimulation procedures such as infection, bleeding, headache or changes in mood or cognition.

START Trial Eligibility Criteria

Inclusion Criteria

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

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I have tried at least two seizure medications without success.

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I am between 18 and 75 years old.

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I have epilepsy with at least 2 severe seizures a month.

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I am not pregnant and use birth control if I'm sexually active.

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My seizures originate from the middle part of my temporal lobe.

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I can complete a brain function test and score within the normal range.

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My body can accommodate the Medtronic device close to my skin.

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I am willing to keep my seizure medications unchanged during the study.

START Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 45 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 45 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 45 months 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 Conscious Awareness

Secondary outcome measures

Change in Quality of Life

Change in Seizure Severity

Other outcome measures

Change in Seizure Frequency

START Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Therapeutic Thalamic StimulationExperimental Treatment2 Interventions

Four months post implant, the neurostimulator device will provide patients with hippocampal stimulation for all seizures. For seizures longer than five seconds, thalamic stimulation will be administered at a therapeutic level established based on the physician's evaluation and patient specific parameters established at a previous visit. This will occur in half of the seizures the patient experiences and will be randomly assigned during this phase of the study. If no benefit is experienced during this phase of the study, patients may participate in an optional randomized CL stimulation phase for an additional four months.

Group II: Non-Therapeutic Thalamic StimulationPlacebo Group1 Intervention

Four months post implant, the neurostimulator device will provide patients with hippocampal stimulation for all seizures. For seizures longer than five seconds, thalamic stimulation will be administered at below therapeutic threshold to control for implant and placebo effects. This will occur in half of the seizures the patient experiences and will be randomly assigned during this phase of the study. If no benefit is experienced during this phase of the study, patients may participate in an optional randomized CL stimulation phase for an additional four months.

0 / 8Eligibility criteria met

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Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,339 Previous Clinical Trials

649,385 Total Patients Enrolled

Yale UniversityLead Sponsor

1,847 Previous Clinical Trials

2,736,523 Total Patients Enrolled

Mayo ClinicOTHER

3,205 Previous Clinical Trials

3,766,779 Total Patients Enrolled

Media Library

Central Thalamic Stimulation (Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04897776 — N/A

Temporal Lobe Epilepsy Research Study Groups: Therapeutic Thalamic Stimulation, Non-Therapeutic Thalamic Stimulation

Temporal Lobe Epilepsy Clinical Trial 2023: Central Thalamic Stimulation Highlights & Side Effects. Trial Name: NCT04897776 — N/A

Central Thalamic Stimulation (Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04897776 — N/A

Frequently Asked Questions

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

Does this research project extend to adults over 20 years of age?

"In order to participate in this drug trial, applicants must be aged between 18 and 75. There are 103 clinical trials for minors and 158 studies dedicated exclusively to persons above the retirement age."

Answered by AI

What are the eligibility requirements for participation in this medical trial?

"Only individuals that meet the criteria of having epilepsy, uncinate and being between 18-75 years old are able to participate in this trial. This study is hoping to enroll up to 5 patients."

Answered by AI

Recent research and studies

EpilepsiaJournal

Brain-responsive Neurostimulation in Patients with Medically Intractable Mesial Temporal Lobe Epilepsy

Geller, Eric B., Tara L. Skarpaas, Robert E. Gross, Robert R. Goodman, Gregory L. Barkley, Carl W. Bazil, Michael J. Berg, et al.. 2017. “Brain-responsive Neurostimulation in Patients with Medically Intractable Mesial Temporal Lobe Epilepsy”. Epilepsia. Wiley. doi:10.1111/epi.13740.

NatureJournal

Behavioural Improvements with Thalamic Stimulation After Severe Traumatic Brain Injury

Schiff, N. D., J. T. Giacino, K. Kalmar, J. D. Victor, K. Baker, M. Gerber, B. Fritz, et al.. 2007. “Behavioural Improvements with Thalamic Stimulation After Severe Traumatic Brain Injury”. Nature. Springer Science and Business Media LLC. doi:10.1038/nature06041.

Brain Research BulletinJournal

Electrical Stimulation of Hippocampus for the Treatment of Refractory Temporal Lobe Epilepsy

Han, Chun-Lei, Wei Hu, Matt Stead, Tan Zhang, Jian-Guo Zhang, Gregory A. Worrell, and Fan-Gang Meng. 2014. “Electrical Stimulation of Hippocampus for the Treatment of Refractory Temporal Lobe Epilepsy”. Brain Research Bulletin. Elsevier BV. doi:10.1016/j.brainresbull.2014.08.007.

IEEE Journal of Translational Engineering in Health and MedicineJournal