Neural Basis of Cognition

Epilepsy Clinical Trial

Official title:

Studying Human Cognition and Neurological Disorders Using µECoG Electrodes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05132543
• Other study ID #: Pro00072892
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: September 15, 2027

Study information

• Verified date: June 2024
• Source: Duke University
• Contact: Gregory B Cogan, PhD
• Phone: 919-681-7601
• Email: gregory.cogan[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall purpose of this study is to better understand human cognition and human epilepsy by working with patients undergoing clinical treatment for pharmacologically resistant epilepsy. The investigators will investigate human cognition by conducting controlled experiments that focus on sensory, motor, and cognitive phenomena such as sensory processing, memory, and language. The investigators will also examine the neural underpinnings of epilepsy during both sleep and wakefulness to better understand both the foundations of epilepsy and how epilepsy affects cognition. The investigators hope to use these data to have a better understanding of cognition, epilepsy, and how the two interact. This will potentially lead to better markers for seizure onsets as well as epilepsy more generally. For this research, the investigators will use μECoG arrays manufactured by commercial partners. These arrays have passed all major ISO 10993 bio-compatibility tests. Based on this characterization and use in the intraoperative setting (limited duration and supervised usage), these devices pose a minimal risk to participants. Data will be analyzed and protected using the Duke SSRI protected research data network.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: September 15, 2027
• Est. primary completion date: September 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Potential subjects will come from adult and pediatric patients (between the ages of 12 and 18) undergoing surgery for the treatment of pharmacologically resistant epilepsy, brain tumor resection, brain mass resection, or deep brain stimulation (DBS) for the first time

• Proficient English speakers

• No Major cognitive impairment

Exclusion Criteria:

• Previous DBS procedure

• Subject unable to consent to study

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• High density micro-electrocorticography for neural speech prothesis
ECoG electrodes are thin, high-density, flexible electrode arrays used for recording electrophysiological signals from the brain.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evoked signal-to-noise analysis human brain.	This study will compare the neural response sensitivity of intraoperative µECoG recording to those of in-unit recordings with macro-ECoG and SEEG. The strength and reliability of the high gamma (HG) response are critical for speech decoding algorithms. For all recordings, the HG power modulation ratio over baseline during speech perception and production will be measured and compared with non-parametric statistical tests.	Intraoperative data collection period, 20 minutes
Primary	Percentage of phoneme decoding accuracy as measured by linear decoding model		Intraoperative data collection period, 20 minutes
Primary	Number of HG power modulation as measured by signal power.		Intraoperative data collection period, 20 minutes
Primary	Number of kriging resolution as measured by signal power.		Intraoperative data collection period, 20 minutes
Secondary	Number of serious adverse events as measured by medical record review		Implantation to Three-months follow-up