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NCT01958086 · ClinicalTrials.gov registry record · NA
Visuomotor Prosthetic for Paralysis
A NA study of Quadriplegia, sponsored by Richard A. Andersen, PhD.
- Recruiting
- Registry status
- NA
- Development phase
- 2
- Enrollment target
- 3
- Study locations
NCT01958086: Recruiting NA study of Quadriplegia, sponsored by Richard A. Andersen, PhD.
NCT01958086 is a NA study of Quadriplegia that is actively recruiting participants, run by Richard A. Andersen, PhD. The registered enrollment target is 2 participants, below the 9-participant average among 6 other Quadriplegia trials with a reported enrollment target (78% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01958086, a NA study of Quadriplegia, is actively recruiting participants, sponsored by Richard A. Andersen, PhD.
- RECRUITING
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
- 3
- Study locations
Study Summary
The investigators objective is to run human clinical trials in which brain activity recorded through a "brain-chip" implanted in the human brain can be used to provide novel communication capabilities to severely paralyzed individuals by allowing direct brain-control of a computer interface. A prospective, longitudinal, single-arm early feasibility study will be used to examine the safety and effectiveness of using a neural communication system to control a simple computer interface and a tablet computer. Initial brain control training will occur in simplified computer environments, however, the ultimate objective of the clinical trial is to allow the human patient autonomous control over the Google Android tablet operating system. Tablet computers offer a balance of ease of use and functionality that should facilitate fusion with the BMI. The tablet interface could potentially allow the patient population to make a phone call, manage personal finances, watch movies, paint pictures, play videogames, program applications, and interact with a variety of "smart" devices such as televisions, kitchen appliances, and perhaps in time, devices such as robotic limbs and smart cars. Brain control of tablet computers has the potential to greatly improve the quality of life of severely paralyzed individuals. Five subjects will be enrolled, each implanted with the NCS for a period of at least 53 weeks and up to 313 weeks. The study is expected to take at least one year and up to six years in total.
Primary Outcome
Assessments will be compared with chance and previous reports of BMI efficacy using control signals derived from primary motor cortex. Computer-interface competency examination that measures the ability of the subject to control various aspects of the tablet user interface. Additionally we will measure the Quality of Life Inventory (QOLI) at regular intervals over the duration of the study. Changes in performance over time.
Conditions Studied
Interventions
- DEVICE Neural Communication System
Study Locations (3)
California
- University of California Los Angeles - Los Angeles
- California Institute of Technology - Pasadena
- Casa Colina Centers for Rehabilitation - Pomona
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2013-10-01 |
| Est. Completion | 2031-07-31 |
| Phase | NA |
What NCT01958086 shows while recruiting
NCT01958086 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 9-participant average among 6 other Quadriplegia trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Quadriplegia appearing as the primary indexed condition, and to 1 intervention - of which Neural Communication System is the first listed.
NCT01958086 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01958086 about?
NCT01958086 is a clinical study titled "Visuomotor Prosthetic for Paralysis". The investigators objective is to run human clinical trials in which brain activity recorded through a "brain-chip" implanted in the human brain can be used to provide novel communication capabilities to severely paralyzed individuals by allowing direct brain-control of a computer interface. A prosp...
What is the current status of trial NCT01958086?
This trial is currently recruiting. It is a NA study. The enrollment target is 2 participants. The study started on 2013-10-01. Estimated completion is 2031-07-31.
What conditions does trial NCT01958086 study?
This clinical trial studies the following conditions: Quadriplegia.
What interventions are being tested in trial NCT01958086?
The interventions under investigation include: Neural Communication System (DEVICE).
Who is sponsoring clinical trial NCT01958086?
This trial is sponsored by Richard A. Andersen, PhD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01958086 being conducted?
This trial has 3 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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