CLINICAL TRIAL

Customizing the Body-Machine Interface for Spinal Cord Injuries

Waitlist Available · 18+ · All Sexes · Chicago, IL

This study is evaluating whether it is possible to develop personalized interfaces for people with tetraplegia.

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About the trial for Spinal Cord Injuries

Eligible Conditions
Spinal Cord Injuries (SCI) · Spinal Cord Injuries

Treatment Groups

This trial involves 2 different treatments. Customizing The Body-Machine Interface is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Customizing the Body-Machine Interface
DEVICE
Experimental Group 2
Customizing the Body-Machine Interface
DEVICE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
tetraplegia, have a devastating impact on the quality of life of people with these injuries show original
Able to understand the questions The patient is able to speak and respond to questions and understand the questions. show original
Age 18-65
The dog is able to follow simple commands. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline and 8 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline and 8 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Customizing the Body-Machine Interface will improve 1 primary outcome and 3 secondary outcomes in patients with Spinal Cord Injuries. Measurement will happen over the course of Baseline and 8 months.

Change in Movement Smoothness from Baseline at 8 months
BASELINE AND 8 MONTHS
This outcome measure measures the change in movement smoothness when operating the virtual and real wheelchairs
Change in Time to task completion from Baseline at 8 months
BASELINE AND 8 MONTHS
The subjects will perform computer games requiring different data entry tasks (characters, cursor control) and navigate either a virtual or a real obstacle course. This primary outcome measure is the time it takes subjects to complete each task.
Change in Mental State
BASELINE AND 8 MONTHS
This outcome measures measures the change in mental state (as quantified by the State-Trait Anxiety Inventory) after training
Change in Strength
BASELINE AND 8 MONTHS
This outcome measure measures the changes in upper body strength after training

Who is running the study

Principal Investigator
F. M.
Ferdinando Mussa-Ivaldi, Senior Research Scientist
Shirley Ryan AbilityLab

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can spinal cord injuries be cured?

Although the prognosis for patients with SCI is better than for the general population, there does not appear to be a cure for SCI. The best we can propose is that patients should be managed in a way that meets their individual needs and that this should include an awareness of their own expectations and an assessment of their abilities and their wish to cope with their disability. In the future, however, new knowledge will allow a clearer picture to emerge.

Anonymous Patient Answer

What are the signs of spinal cord injuries?

The signs of spinal cord injuries include pain, paralysis, bladder dysfunction, bowel and bladder dysfunction, incontinence, and loss of bladder or bowel control. Also an intact sensation of the skin is a good indicator for the preservation of urinary or anal sphincters.

Anonymous Patient Answer

What is spinal cord injuries?

Nearly 90,000 new cases occur in the US each year. Although they can affect many functions of the body, nearly half of cases involve a single, complete loss of muscle and nerve function, which is termed a complete transection. In the USA, the injury occurs most frequently in those 25-40 years old (27%), and is equally frequent in males and females (14% male; 13% female). The National Institutes of Health Spinal Cord Injury Clinical Research Center (NINCDS C-R-16) at the National Institutes of Health sponsors the S-CORT study.

Anonymous Patient Answer

What causes spinal cord injuries?

In a country that has only moderate traumatic injury incidence, the majority of injuries are nontraumatic. However, the incidence of SCI is increasing, especially at a younger age.

Anonymous Patient Answer

What are common treatments for spinal cord injuries?

In the first two decades after an injury, treatment for patients with spinal cord contusions includes immediate conservative measures with careful attention to patients' comfort and treatment of complications, and supportive care, including physical therapy and occupational therapy. Patients with epidural hematoma may benefit from surgical decompression if symptoms are mild but rapid neurological deterioration develops, whereas patients with mild symptoms that do not improve when treated with nonsurgical measures may benefit from surgical decompression at some interval after injury.

Anonymous Patient Answer

How many people get spinal cord injuries a year in the United States?

Almost 19,500 Americans are hospitalized per year with spinal cord injuries. The rate of spinal cord injuries tripled between 1955 and 1973. Preventable causes have contributed to the rapid increases of the prevalence of spinal cord injuries, and the national rate may be as high as 1.35 spinal cord injury admissions/100,000 population.

Anonymous Patient Answer

What is the average age someone gets spinal cord injuries?

The average age of a SCI sufferer is 44, or approximately 28 years younger than the average American. While still young, [not all doctors in the United States are aware that SCIs are more frequent in [young] black men than in [young] white men] (https://www.fhi.org/sites/default/files/health%20resources/fact-sheets/fact-sheets-courses-teacher/med%20-friendly_lessons.pdf). As a result, spinal cord injury is less likely to be a concern in [young, white] men.

Anonymous Patient Answer

What is the primary cause of spinal cord injuries?

Recent findings, trauma was the sole primary cause of thoraco-lumbar and lumbar SCIs by itself or in combination with another injury. It has become a trend to place less emphasis on the history and physical examination of the spinal cord in the workup of SCI. As we gain more knowledge about the causes of SCI, we can more accurately prevent SCI and other spinal cord injuries.

Anonymous Patient Answer

Is customizing the body-machine interface typically used in combination with any other treatments?

The majority of participants, 66%, had some form of customizing treatment in combination with other treatments. Customizing treatments may be of value when combined with other treatments to optimize the effects of these treatments and to enhance recovery. Inclusion and exclusion criteria from clinical studies of rehabilitation in combination with other treatments may need to adjusted to be appropriate for patients who require customized therapy to address the individual needs of their condition. Copyright © 2015 John Wiley&Sons, Ltd.

Anonymous Patient Answer

Has customizing the body-machine interface proven to be more effective than a placebo?

Results from a recent paper shows that, by modifying the way that the BM-I interacts with the human, a new method for enhancing functional recovery of the human body and for enhancing recovery in the whole human system can be developed.

Anonymous Patient Answer

How does customizing the body-machine interface work?

With a single system design for both upper- and lower- extremities, the most effective BMA design that can support all users is a modular one. With current hardware, this would be a multi-chambered FSM that includes an upper extremities module, a lower extremities module and a waist module. The waist module will allow users to control their BMA remotely without putting forward full weight on their upper limbs or knees.

Anonymous Patient Answer
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