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NCT01964261 · ClinicalTrials.gov registry record · NA

Sensory Motor Transformations in Human Cortex

A NA study of Quadriplegia, sponsored by Richard A. Andersen, PhD.

Recruiting
Registry status
NA
Development phase
5
Enrollment target
4
Study locations

NCT01964261: Recruiting NA study of Quadriplegia, sponsored by Richard A. Andersen, PhD.

NCT01964261 is a NA study of Quadriplegia that is actively recruiting participants, run by Richard A. Andersen, PhD. The registered enrollment target is 5 participants, below the 9-participant average among 6 other Quadriplegia trials with a reported enrollment target (44% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01964261, a NA study of Quadriplegia, is actively recruiting participants, sponsored by Richard A. Andersen, PhD.

RECRUITING
Registry status
NA
Development phase
5 participants
Enrollment target
4
Study locations

Study Summary

This research study is being conducted to develop a brain controlled medical device, called a brain-machine interface. The device will provide people with a spinal cord injury some ability to control an external device such as a computer cursor or robotic limb by using their thoughts along with sensory feedback. Development of a brain-machine interface is very difficult and currently only limited technology exists in this area of neuroscience. Other studies have shown that people with high spinal cord injury still have intact brain areas capable of planning movements and grasps, but are not able to execute the movement plans. The device in this study involves implanting very fine recording electrodes into areas of the brain that are known to create arm movement plans and provide hand grasping information and sense feeling in the hand and fingers. These movement and grasp plans would then normally be sent to other regions of the brain to execute the actual movements. By tying into those pathways and sending the movement plan signals to a computer instead, the investigators can translate the movement plans into actual movements by a computer cursor or robotic limb. A key part of this study is to electrically stimulate the brain by introducing a small amount of electrical current into the electrodes in the sensory area of the brain. This will result in the sensation of touch in the hand and/or fingers. This stimulation to the brain will occur when the robotic limb touches the object, thereby allowing the brain to "feel" what the robotic arm is touching. The device being used in this study is called the Neuroport Array and is surgically implanted in the brain. This device and the implantation procedure are experimental which means that it has not been approved by the Food and Drug Administration (FDA). One Neuroport Array consists of a small grid of electrodes that will be implanted in brain tissue and a small cable that runs from the electrode grid to a small hourgl

Primary Outcome

The primary effectiveness objective of this study is to evaluate the effectiveness of the NPS2 in controlling virtual or physical end effectors. Signals from posterior parietal cortex will allow the subject to control the end effector with accuracy significantly greater than chance; the subject will be able to perceive and discriminate ICMS above the level of chance; and,incorporating stimulation will improve the subject's control over the end effector. We will evaluate the effectiveness of the

Conditions Studied

Interventions

  • DEVICE Neural Prosthetic System 2 (NPS2)

Study Locations (4)

California

  • Rancho Los Amigos National Rehabilitation Center - Downey
  • University of Southern California - Los Angeles
  • Richard Andersen - Pasadena

Colorado

  • University of Colorado Anschutz Medical Campus - Aurora

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2013-11-01
Est. Completion 2027-01-31
Phase NA
Richard A. Andersen, PhD

3 total trials

What NCT01964261 shows while recruiting

NCT01964261 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 9-participant average among 6 other Quadriplegia trials with a reported enrollment target (44% lower).

The record links to 1 condition, with Quadriplegia appearing as the primary indexed condition, and to 1 intervention - of which Neural Prosthetic System 2 (NPS2) is the first listed.

NCT01964261 reports a single indexed study location in California, Colorado.

Frequently Asked Questions

What is clinical trial NCT01964261 about?

NCT01964261 is a clinical study titled "Sensory Motor Transformations in Human Cortex". This research study is being conducted to develop a brain controlled medical device, called a brain-machine interface. The device will provide people with a spinal cord injury some ability to control an external device such as a computer cursor or robotic limb by using their thoughts along with sens...

What is the current status of trial NCT01964261?

This trial is currently recruiting. It is a NA study. The enrollment target is 5 participants. The study started on 2013-11-01. Estimated completion is 2027-01-31.

What conditions does trial NCT01964261 study?

This clinical trial studies the following conditions: Quadriplegia.

What interventions are being tested in trial NCT01964261?

The interventions under investigation include: Neural Prosthetic System 2 (NPS2) (DEVICE).

Who is sponsoring clinical trial NCT01964261?

This trial is sponsored by Richard A. Andersen, PhD, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01964261 being conducted?

This trial has 4 study locations across California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT01964261, the US trial registry maintained by the National Library of Medicine. NCT01964261 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.