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Navigation and Free Recall in Chronically Implanted Humans

Primary Purpose

Epilepsy

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
electrical stimulation
Sponsored by
Barbara Jobst
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Epilepsy focused on measuring Memory, Responsive Neurostimulator System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dartmouth-Hitchcock Medical Center in Lebanon, NH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RNS® Neurostimulator

Arm Description

Subjects with pharmaceutically intractable seizures who have been implanted with a RNS® Neurostimulator.

Outcomes

Primary Outcome Measures

Proportion of words recalled with and without stimulation.
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.

Secondary Outcome Measures

Changes in the power spectrum of ECoG data with an increase of recalled words.
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.
Proportion of words recalled during times of interictal activity.
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.
Proportion of navigation challenges recalled successfully with and without stimulation.
This outcome will be assessed by real-world and virtual navigation tasks.

Full Information

First Posted
May 5, 2016
Last Updated
July 14, 2023
Sponsor
Barbara Jobst
Collaborators
NeuroPace
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1. Study Identification

Unique Protocol Identification Number
NCT02781129
Brief Title
Navigation and Free Recall in Chronically Implanted Humans
Official Title
Memory, Epilepsy and Brain Stimulation: Oscillatory Patterns During Real-world Navigation and Free Recall in Chronically Implanted Humans
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Barbara Jobst
Collaborators
NeuroPace

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Memory, Responsive Neurostimulator System

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RNS® Neurostimulator
Arm Type
Experimental
Arm Description
Subjects with pharmaceutically intractable seizures who have been implanted with a RNS® Neurostimulator.
Intervention Type
Other
Intervention Name(s)
electrical stimulation
Intervention Description
Stimulation applied will be within parameters commonly used for the treatment of epilepsy during periods of encoding, recall, and memory maintenance .
Primary Outcome Measure Information:
Title
Proportion of words recalled with and without stimulation.
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Changes in the power spectrum of ECoG data with an increase of recalled words.
Description
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.
Time Frame
30 days
Title
Proportion of words recalled during times of interictal activity.
Description
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.
Time Frame
30 days
Title
Proportion of navigation challenges recalled successfully with and without stimulation.
Description
This outcome will be assessed by real-world and virtual navigation tasks.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara C Jobst, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center in Lebanon, NH
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Navigation and Free Recall in Chronically Implanted Humans

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