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Procedure

ANT recording and stimulation for Epilepsy

N/A
Waitlist Available
Led By Derek Southwell, M.D., Ph.D.
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All epilepsy patients admitted to Duke Hospital for surgical placement of depth electrodes age 18 and up are eligible
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measurements will be made 7-14 days following surgery for seeg placement
Awards & highlights

Study Summary

In this study, the investigator aims to perform cortical stereo electroencephalogram (sEEG) recordings during simultaneous anterior nucleus of the thalamus (ANT) recording and stimulation to better understand the following: 1) how the ANT is involved in various seizure types; 2) which cortical regions are modulated by established ANT stimulation patterns; and 3) how novel ANT stimulation patterns modify epileptogenic cortical activity. Together, this knowledge will advance ANT deep brain stimulation (DBS) therapy by providing a physiologic basis for patient selection for ANT DBS, while identifying brain signals and stimulation patterns that can be used to develop novel methods for ANT DBS. Up to 15 adult patients (18 and older) who present to Duke Neurosurgery for routine seizure localization using sEEG will be asked to enroll in this pilot study of ANT recording and stimulation. In the course of surgical epilepsy treatment, patients routinely undergo surgical placement of sEEG electrodes for the purposes of seizure localization. During this procedure, 2 additional leads will be placed in the ANT. These patients remain hospitalized for 7-14 days after sEEG placement, during which time their seizure medications are tapered. Concurrent video monitoring is performed while continuous neural recordings are made through the sEEG electrodes. Additionally, continuous recordings will be performed through the electrodes placed in the thalamus. Periodically, standard intermittent high-frequency stimulation (130 Hz, 90-ms pulse width, and 2 mA intensity) will be performed with a 60-s on and a 300-s off cycle after surgery. These standard ANT stimulation parameters are employed clinically. Data will include the sEEG recordings marked for ANT stimulation, any side effects, medications, past medical history (PMH), and tests/procedures during the hospital stay. Risks involved are as described for the standard depth electrode surgery with the addition of the possible side effects from the stimulation which include sensations of numbness and tingling, and possibly increased seizure activity.

Eligible Conditions
  • Epilepsy
  • Seizures

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measurements will be made 7-14 days following surgery for seeg placement
This trial's timeline: 3 weeks for screening, Varies for treatment, and measurements will be made 7-14 days following surgery for seeg placement for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent changes from baseline in power (dB)
Percent changes from baseline in rates of high frequency oscillations
Percent changes from baseline in rates of interictal spikes
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ANT recording and stimulationExperimental Treatment1 Intervention
Up to 15 adult patients who present to Duke Neurosurgery for routine seizure location using sEEG will be asked to enroll in this pilot study of ANT recording and stimulation. Once enrolled in the trial, subjects will have additional placement of two thalamic electrodes during the course of standard sEEG placement surgery. Patients routinely remain hospitalized for 7-14 days after sEEG placement, during which time their seizure medications are tapered. Continuous neural recordings are made through the sEEG electrodes for the purposes of seizure localization during the entire time the depth electrodes are in place. Up to three times daily, standard intermittent high-frequency stimulation [130 Hertz (Hz), 90-millisecond pulse width, and 2 milliamps (mA) intensity] will be performed with a 60-seconds on and a 300-seconds off cycle following surgery up to the entire length of sEEG monitoring.

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Who is running the clinical trial?

Duke UniversityLead Sponsor
2,360 Previous Clinical Trials
3,420,330 Total Patients Enrolled
9 Trials studying Epilepsy
31,504 Patients Enrolled for Epilepsy
Derek Southwell, M.D., Ph.D.Principal InvestigatorDuke Health

Frequently Asked Questions

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~0 spots leftby Jan 2025