Navigation and Free Recall in Chronically Implanted Humans
Memory, Epilepsy and Brain Stimulation: Oscillatory Patterns During Real-world Navigation and Free Recall in Chronically Implanted Humans
1 other identifier
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 5, 2016
CompletedFirst Posted
Study publicly available on registry
May 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedJuly 30, 2025
July 1, 2025
9 years
May 5, 2016
July 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
30 days
Secondary Outcomes (3)
Changes in the power spectrum of ECoG data with an increase of recalled words.
30 days
Proportion of words recalled during times of interictal activity.
30 days
Proportion of navigation challenges recalled successfully with and without stimulation.
30 days
Study Arms (1)
RNS® Neurostimulator
EXPERIMENTALSubjects with pharmaceutically intractable seizures who have been implanted with a RNS® Neurostimulator.
Interventions
Stimulation applied will be within parameters commonly used for the treatment of epilepsy during periods of encoding, recall, and memory maintenance .
Eligibility Criteria
You may qualify if:
- able to give informed consent
- 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
You may not qualify if:
- RNS® Neurostimulator implanted within 3 months of experimental tasks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Barbara Jobstlead
- NeuroPacecollaborator
Study Sites (1)
Dartmouth-Hitchcock Medical Center in Lebanon, NH
Lebanon, New Hampshire, 03766, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara C Jobst, MD
Dartmouth-Hitchcock Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
May 5, 2016
First Posted
May 24, 2016
Study Start
May 1, 2016
Primary Completion
May 1, 2025
Study Completion
May 1, 2025
Last Updated
July 30, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share