Navigation and Free Recall in Chronically Implanted Humans

Not Applicable

• Conditions: Epilepsy
• Interventions: Other: electrical stimulation

• Registration Number: NCT02781129
• Lead Sponsor: Barbara Jobst

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-05
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-24
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RNS® Neurostimulator	electrical stimulation	Subjects with pharmaceutically intractable seizures who have been implanted with a RNS® Neurostimulator.

Primary Outcome Measures

Name	Time	Method
Proportion of words recalled with and without stimulation.	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.

Secondary Outcome Measures

Name	Time	Method
Changes in the power spectrum of ECoG data with an increase of recalled words.	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.
Proportion of words recalled during times of interictal activity.	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.
Proportion of navigation challenges recalled successfully with and without stimulation.	30 days	This outcome will be assessed by real-world and virtual navigation tasks.

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center in Lebanon, NH; 🇺🇸 Lebanon, New Hampshire, United States