Patients are searching for this trial right now

This page is already ranking on Google. Activate it to start receiving pre-qualified patient leads directly in your inbox.

14-day free trial · $44/mo after · Cancel anytime · Money-back guarantee

NCT01964261 · Richard A. Andersen, PhD

Sensory Motor Transformations in Human Cortex

What this study is about

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.

View original scientific description

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 hourglass-shaped pedestal. This pedestal is designed to be attached to the skull and protrude through the scalp to allow for connection with the computer equipment. The top portion of the pedestal has a protective cover that will be in place when the pedestal is not in use. The top of this pedestal and its protective cover will be visible on the outside of the head. Three Neuroport Arrays and pedestals will be implanted in this study so three of these protective covers will be visible outside of the head. It will be possible to cover these exposed portions of the device with a hat or scarf. The investigators hope to learn how safe and effective the Neuroport array plus stimulation is in controlling computer generated images and real world objects, such as a robotic arm, using imagined movements of the arms and hands.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • High cervical spinal lesion
  • Able to provide informed consent
  • Able to understand and comply with instructions in English
  • Communicate via speech
  • Surgical clearance
  • Life expectancy greater than 12 months
  • Travel up to 60 miles to study locations up to five days per week
  • Caregiver monitor for surgical site complications and behavioral changes on a daily basis
  • Psychosocial support system

Exclusion criteria

  • Presence of memory problems
  • Intellectual impairment
  • Psychotic illness or chronic psychiatric disorder, including major depression if untreated
  • Poor visual acuity
  • Active infection or unexplained fever
  • Scalp lesions or skin breakdown
  • HIV or AIDS infection
  • Active cancer or chemotherapy
  • Autonomic dysreflexia
  • History of seizure
  • Implanted hydrocephalus shunt
  • Previous neurosurgical history affecting parietal lobe function
  • Medical conditions contraindicating surgery and chronic implantation of a medical device
  • Prior cranioplasty
  • Unable to undergo MRI or anticipated need for MRI during study
  • Nursing an infant or unwilling to bottle-feed infant
  • Chronic oral or intravenous use of steroids or immunosuppressive therapy
  • Suicidal ideation
  • Drug or alcohol dependence
  • Planning to become pregnant, or unwilling to use adequate birth control
  • Implanted Cardiac Defibrillator, Pacemaker, vagal nerve stimulator, or spinal cord stimulator.
  • Implanted deep brain stimulator (DBS), DBS leads, or cochlear implant.

Where

  • Downey, California
  • Los Angeles, California
  • Pasadena, California
  • Aurora, Colorado

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced May 22, 2025 · Source of record for eligibility and locations

📊
1 of 5 participants interested
20% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Downey

California

Location available
RECRUITING

Los Angeles

California

Location available
RECRUITING

Pasadena

California

Location available
RECRUITING

Aurora

Colorado

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Find More Alzheimers Disease Trials by City

Browse all alzheimers disease clinical trials in these cities — not just this study.

Looking for Quadriplegia Treatment in Downey?

Join others in California exploring innovative treatment options through clinical research

Quadriplegia Treatment Options in Downey, California

If you're searching for Quadriplegia treatment in Downey, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Downey, Los Angeles, Pasadena and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Quadriplegia. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 5 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Quadriplegia?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Quadriplegia

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Quadriplegia Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT01964261. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.