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Brain Stimulation

Thalamic Stimulation for Temporal Lobe Epilepsy (START Trial)

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

Must not have

Significant platelet dysfunction from medical conditions or medications

On anticoagulants and unable to discontinue them peri-surgically

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 45 months

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition or take medication that affects how my blood clots.

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I am on blood thinners and cannot stop them for surgery.

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I have been diagnosed with seizures not caused by epilepsy.

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I do not have severe lung, heart disease, or ongoing infections.

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I've had epilepsy surgery that could affect where electrodes are placed.

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I cannot have surgery on my brain.

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I have been diagnosed with primary generalized seizures.

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I had a sudden, severe seizure without a clear cause in the last year.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Conscious Awareness

Secondary study objectives

Change in Quality of Life

Change in Seizure Severity

Other study objectives

Change in Seizure Frequency

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 / 16Eligibility criteria met