Evaluation and Stimulation of Hippocampal Neuronal Ensembles in Patients Undergoing Intracranial Monitoring for Medically Refractory Epilepsy

What we are studying

We have developed the ability to collect microrecording data from identified single hippocampal neurons for the development of algorithmic models of neuronal ensemble function by implanting conformal recording/stimulating electrodes into specific human hippocampal subfields (see IRB 00021100). Subsequently, by developing and applying specific feedback-based stimulation patterns derived from a conformal, multineuron closed-loop model, recovery of cognitive impairment and the facilitation of memory function can be achieved. A related method has been shown safe and efficacious in recovery of cognitive impairment and memory facilitation in both the rodent hippocampus (Berger et al., 2011;Hampson et al., 2012) and primate prefrontal cortex (Robert E Hampson and Greg, 2012), and as will be described below, has a safe precedent in human subjects.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Potential subjects will be identified by clinician referral during evaluation of patients for standard invasive epilepsy monitoring. At neurosurgical evaluation
  • A member of the research team will contact the patient with a detailed description of the project which will include verbal and/or written documentation. Efforts will be made to ensure equal access to participation between women and minorities by evaluating each potential monitoring candidate as a potential for inclusion in this study.

What is involved

  • Study procedures will be conducted in an inpatient setting. Confidentiality will be protected by collecting only information needed to assess study outcomes
  • Minimizing to the fullest extent possible the collection of any information that could directly identify subjects
  • And maintaining all study information in a secure manner. To help ensure subject privacy and confidentiality
  • Only a unique study identifier will appear on the data collection form. Any collected patient identifying information corresponding to the unique study identifier will be maintained on a linkage file
  • Store separately from the data. The linkage file will be kept secure
  • With access limited to designated study personnel. Following data collection subject identifying information will be deleted or destroyed within three years after closure of the study
  • By commercial provider
  • Consistent with data validation and study design
  • Producing an anonymous analytical data set. Data access will be limited to study staff. Data and records will be kept locked and secured
  • With any computer data password protected. No reference to any individual participant will appear in reports
  • Presentations
  • Or publications that may arise from the study.

Compensation

None

Contact Information

Study Coordinator
Wendy Jenkins, RN BSN, CCRC
Email
wejenkin@wakehealth.edu
Phone
3367169728
Principal Investigator
Daniel E. Couture, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.