Feasibility Study of Deep Brain Recordings for Learning and Memory

Movement Disorders Clinical Trial

Official title:

A Feasibility Study of Deep Brain Recordings for Learning and Memory

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02417727
• Other study ID #: 150102
• Secondary ID: 15-N-0102
• Status: Withdrawn
• Start date: March 23, 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: October 23, 2015
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• INCLUSION CRITERIA:

Adults at least age 18

Currently enrolled in 11-N-0211

EXCLUSION CRITERIA:

Unable to provide own informed consent

Related Conditions & MeSH terms

• Movement Disorders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Permission to share data from partiicpation on NIH protocol #11-N-0211		ongoing