What side effects are associated with this type of intervention?

Common treatments for epilepsy include antiepileptic drugs (AEDs) and neuromodulation therapies such as electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS). AEDs often cause mild and reversible side effects like dizziness, fatigue, and gastrointestinal issues, though some may have more severe effects like mood changes or cognitive impairment. ECT, while effective, can lead to transient memory loss and confusion. rTMS is generally well-tolerated but may cause headaches or scalp discomfort. Both ECT and rTMS are considered when patients do not respond to standard pharmacotherapy.

What prior FDA approvals exist?

The FDA has approved several neuromodulation devices for the treatment of epilepsy, including the Vagus Nerve Stimulation (VNS) Therapy System and the Responsive Neurostimulation (RNS) System. VNS involves electrical stimulation of the vagus nerve to reduce seizure frequency, while RNS delivers targeted electrical pulses to specific brain regions to prevent seizures. Additionally, various antiepileptic drugs (AEDs) such as valproate, lamotrigine, and topiramate have been approved for epilepsy management. These treatments aim to control seizures through different mechanisms, either by modulating neural activity directly or by pharmacological means.

What other types of research exist?

Promising novel alternatives to intracranial recordings and microstimulation for epilepsy patients include transcutaneous supraorbital nerve stimulation and remote electrical neuromodulation. These methods have shown efficacy in reducing migraine pain, which suggests potential applicability for epilepsy treatment. Additionally, transcranial magnetic stimulation (TMS) has shown promise in reducing headache days and may offer benefits for epilepsy management.

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Brain Activity and Neurochemical Monitoring for Epilepsy

N/A

Waitlist Available

Led By Robert Bina, MD

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

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

Must have

Age 18 to 80 years, inclusive

Committee approved candidates for brain surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during hospitalization - 1-2 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial uses advanced computer programs and real-time brain measurements to study how the brain works in epilepsy surgery patients. By recording and stimulating brain activity, researchers aim to understand how brain chemicals like dopamine, serotonin, and norepinephrine affect mood, attention, and behavior.

Who is the study for?

This trial is for adults aged 18-80 with intractable epilepsy or similar conditions requiring brain surgery, fluent in English, and able to consent. Excluded are those with significant cognitive dysfunction, terminal illness, MRI contraindications (like pacemakers), current or planned pregnancy during the study.

What is being tested?

The study tests how cognition and emotion behaviors are linked to brain activity using intracranial monitoring during behavioral tasks on a computer/iPad. It involves standard neuropsychological assessments pre-surgery and additional characterizations through questionnaires.

What are the potential side effects?

Since this isn't a drug trial but an observational one involving standard clinical procedures for epilepsy treatment, specific side effects aren't listed; however, typical risks of neurosurgical procedures may apply.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 80 years old.

Select...

I am approved for brain surgery by a committee.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during hospitalization - 1-2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during hospitalization - 1-2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and during hospitalization - 1-2 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Neurotransmitter Concentration Fluctuation and Pupillary Diameter in Sustained Attention Tasks

Neurotransmitter Concentration Fluctuation in Neuroeconomics Tasks

Neurotransmitter Concentration Fluctuation in Visual Memory

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Behavioral testing under intracranial monitoringExperimental Treatment1 Intervention

Patients will undergo behavioral tasks while being monitored by intercranial electrodes

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for epilepsy include antiepileptic drugs (AEDs) and neuromodulation therapies. AEDs work by stabilizing neuronal membranes and reducing excitability, often by enhancing inhibitory neurotransmission (e.g., GABA) or inhibiting excitatory neurotransmission (e.g., glutamate). Neuromodulation therapies, such as vagus nerve stimulation (VNS) and responsive neurostimulation (RNS), involve direct electrical stimulation to modulate brain activity and prevent seizures. Intracranial recordings and microstimulation, as studied in advanced trials, provide real-time data on brain activity and allow precise modulation of neural circuits. These treatments are crucial for epilepsy patients as they offer targeted and potentially more effective seizure control, especially for those who do not respond to conventional therapies.