Navigation and Free Recall in Chronically Implanted Humans

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02781129
• Other study ID #: D16119
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 2016
• Est. completion date: May 2025

Study information

• Verified date: July 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• electrical stimulation
Stimulation applied will be within parameters commonly used for the treatment of epilepsy during periods of encoding, recall, and memory maintenance .

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center in Lebanon, NH	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Jobst	NeuroPace

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	30 days
Secondary	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.	30 days
Secondary	Proportion of navigation challenges recalled successfully with and without stimulation.	This outcome will be assessed by real-world and virtual navigation tasks.	30 days