Feasibility Study of Deep Brain Recordings for Learning and Memory

A Feasibility Study of Deep Brain Recordings for Learning and Memory

Background:

- Some people with movement disorders are in another NIH protocol. They will have electrodes placed in deep brain areas. They may do tasks before, during, and after surgery. Researchers want to learn more about how brain cells and networks work while people learn and remember. They want to use the data from the other NIH study to do this.

Objective:

- To share data from before and during deep brain stimulation surgery. The data will be used in a study of how the brain learns and remembers.

Eligibility:

- People at least 18 years old who are in protocol 11-N-0211 and have certain movement disorders.

Design:

  • As part of protocol 11-N-0211, data on participants brainwave activity is collected. In this protocol, they will have that data stored and shared.
  • Researchers will access imaging data from deep brain stimulation surgery.
  • Researchers will access other medical records.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

OBJECTIVES:

The purpose of this protocol is to share neural data collected before and during deep brain stimulation surgery with the University of Pennsylvania to identify biomarkers of successful learning and memory.

STUDY POPULATION:

Up to twenty (20) adult subjects who are participating in NIH protocol 11-N-0211 Deep Brain Stimulation Surgery for Movement Disorders who provide written informed consent for sharing and the additional use of their data.

STUDY DESIGN:

This protocol only involves providing consent to share learning and memory data collected under Protocol 11-N-0211. There are no separate or additional participant procedures involved in this protocol.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

Adults at least age 18

Currently enrolled in 11-N-0211

EXCLUSION CRITERIA:

Unable to provide own informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Permission to share data from partiicpation on NIH protocol #11-N-0211
Time Frame: ongoing
ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 23, 2015

Primary Completion (Anticipated)

June 30, 2018

Study Completion (Anticipated)

June 30, 2018

Study Registration Dates

First Submitted

April 15, 2015

First Submitted That Met QC Criteria

April 15, 2015

First Posted (Estimate)

April 16, 2015

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

October 23, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 150102
  • 15-N-0102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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