Navigation and Free Recall in Chronically Implanted Humans

July 14, 2023 updated by: Barbara Jobst

Memory, Epilepsy and Brain Stimulation: Oscillatory Patterns During Real-world Navigation and Free Recall in Chronically Implanted Humans

This study is designed to identify brain activity associated with good memory in subjects with a chronically implanted RNS® device and to study the effects of therapeutic stimulation for epilepsy on memory. This will be accomplished through analysis of ECoG data collected during memory encoding for short and long-term free recall as well as during navigation tasks.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Dartmouth-Hitchcock Medical Center in Lebanon, NH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • able to give informed consent
  • 18 years of age or older
  • Diagnosis of epilepsy
  • Implanted RNS® device and receiving therapeutic stimulation for epilepsy.
  • Capable of completing experimental tasks in the judgment of the Principal Investigator

Exclusion Criteria:

  • RNS® Neurostimulator implanted within 3 months of experimental tasks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RNS® Neurostimulator
Subjects with pharmaceutically intractable seizures who have been implanted with a RNS® Neurostimulator.
Other: electrical stimulation
Stimulation applied will be within parameters commonly used for the treatment of epilepsy during periods of encoding, recall, and memory maintenance .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of words recalled with and without stimulation.
Time Frame: 30 days
This study is designed to study the effects of therapeutic stimulation for epilepsy on memory. This outcome will be assessed by free recall language and memory tasks.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the power spectrum of ECoG data with an increase of recalled words.
Time Frame: 30 days
This study is designed to identify brain activity associated with good memory in subjects with a chronically implanted RNS® device. This outcome will be assessed by free recall language and memory tasks.
30 days
Proportion of words recalled during times of interictal activity.
Time Frame: 30 days
This study is designed to investigate the effects of IEDs on spatial, long-term, and short-term memory. This will be assessed by free recall language and memory tasks.
30 days
Proportion of navigation challenges recalled successfully with and without stimulation.
Time Frame: 30 days
This outcome will be assessed by real-world and virtual navigation tasks.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barbara Jobst

Collaborators

NeuroPace

Investigators

  • Principal Investigator: Barbara C Jobst, MD, Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

May 5, 2016

First Submitted That Met QC Criteria

May 19, 2016

First Posted (Estimated)

May 24, 2016

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 14, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D16119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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