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Completed

NCT Number: NCT02781129

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center in Lebanon, NH

Lebanon, New Hampshire, 03766, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electrical Stimulation

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Barbara Jobst

Other

Collaborators

  • NeuroPace

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
May 24, 2016
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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