Microelectrodes in Epilepsy

NCT05200455 | Completed Results FDA Device

• 2 other identifiers: STUDY000219931R01NS074450-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test microelectrodes in intracranial monitoring to see if they will provide novel information on the epileptic potential of the implanted brain tissue. A secondary objective is to investigate the activity of single neurons during specific cognitive tasks.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Feasibility of Microelectrode Technology to Isolate Place Responsive Neurons in the Human Hippocampus as Measured by the Number of Place Responsive Neurons.

  With the occipito-temporal implantation approach of implantation of microelectrodes, feasibility will measured by the number of place responsive neurons that could be isolated.

  Evaluated for each patient during monitoring period of approximately 2 weeks

Secondary Outcomes (1)

• How Precise the Frequencies (Alpha, Beta, Delta, Theta, Gamma, and High-gamma) of Neural Brain Activity Predict the Speed of the Participant at Performing the Cognitive Task (Accuracy Measured in Percentage).

  Evaluated for each patient during monitoring period of approximately 2 weeks

Study Arms (1)

Microelectrodes

EXPERIMENTAL

Patients who qualify for this study will be implanted with standard electrodes as well as microelectrodes for their intracranial seizure monitoring.

Device: Microelectrodes

Interventions

Microelectrodes DEVICE

Microelectrode implantation

Microelectrodes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year old
• male or female
• right or left handed
• IQ\>70
• medically refractory focal epilepsy requiring intracranial EEG for pre-surgical evaluation deemed medically necessary
• no contraindications to intracranial electrode study
• able and willing to participate in research

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Microelectrodes

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electrodes; Electrical Equipment and Supplies; Equipment and Supplies

Limitations and Caveats

Too few single units were recorded, and it was not possible to identify the units as place cells.

Results Point of Contact

• Title: Dr. Barbara Jobst
• Organization: Dartmouth-Hitchcock Medical Center

Barbara.C.Jobst@hitchcock.org

6036505000

Study Officials

• Barbara C Jobst, MD, PhD

  Section Chief of Adult Neurology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Neurology

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 20, 2022
• Study Start: September 18, 2009
• Primary Completion: March 30, 2021
• Study Completion: May 18, 2021
• Last Updated: September 7, 2022
• Results First Posted: September 7, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)