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Motor Learning in a Customized Body-Machine Interface (BMI)

Primary Purpose

Spinal Cord Injury

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Customizing the Body-Machine Interface
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injury focused on measuring Body-machine interface, Customization, Upper-body motion, Motor learning, Assistive Devices, Wheelchair, Computer keyboard

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-65
  • Injuries at C3-C6 level, complete (ASIA A) or incomplete (ASIA B and C)
  • Able to follow simple commands
  • Able to speak or respond to questions

Exclusion Criteria:

  • Presence of tremors, spasm and other significant involuntary movements
  • Cognitive impairment
  • Deficit of visuo-spatial orientation
  • Concurrent pressure sores or urinary tract infection

(Optional) Additional Exclusion Criteria for evaluation of corticospinal excitability using Transcranial Magnetic Stimulation:

  • Any metal in head with the exception of dental work or any ferromagnetic metal elsewhere in the body. This applies to all metallic hardware such as cochlear implants, or an Internal Pulse Generator or medication pumps, implanted brain electrodes, and peacemaker.
  • Personal history of epilepsy (untreated with one or a few past episodes), or treated patients
  • Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without history of seizure, and without anticonvulsant medication
  • Administration of drugs that potentially lower seizure threshold [62], without concomitant administration of anticonvulsant drugs which potentially protect against seizures occurrence
  • Change in dosage for neuro-active medications (Baclophen, Lyrica, Celebrex, Cymbalta, Gapapentin, Naposyn, Diclofenac, Diazapam, Tramadol, etc) within 2 weeks of any study visit.
  • Skull fractures, skull deficits or concussion within the last 6 months
  • unexplained recurring headaches
  • Sleep deprivation, alcoholism
  • Claustrophobia precluding MRI
  • Pregnancy

Sites / Locations

  • Shirley Ryan AbilityLab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SCI Static

SCI Machine Learning

Arm Description

SCI group that practices with a static body-machine map

Spinal Cord Injury patients who practice with a body-machine map that is adapted using machine learning

Outcomes

Primary Outcome Measures

Change in Time to task completion from Baseline at 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.

Secondary Outcome Measures

Change in Movement Smoothness from Baseline at 8 months
This outcome measure measures the change in movement smoothness when operating the virtual and real wheelchairs
Change in Strength
This outcome measure measures the changes in upper body strength after training
Change in Mental State
This outcome measures measures the change in mental state (as quantified by the State-Trait Anxiety Inventory) after training

Full Information

First Posted
April 16, 2012
Last Updated
November 14, 2019
Sponsor
Shirley Ryan AbilityLab
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01608438
Brief Title
Motor Learning in a Customized Body-Machine Interface
Acronym
BMI
Official Title
Motor Learning in a Customized Body-Machine Interface for Persons With Paralysis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
People with tetraplegia often retain some level of mobility of the upper body. The proposed study will test the hypothesis that it is possible to develop personalized interfaces, which utilize the residual mobility to enable paralyzed persons to control computers, wheelchairs and other assistive devices. If successful the project will result into the establishment of a new family of human-machine interfaces based on wearable sensors that adapt their functions to their users' abilities.
Detailed Description
The goal of these studies is to enable persons paralyzed by spinal cord injury (SCI) to drive powered wheelchairs and interact with computers by acting through an interface that maximizes the effectiveness of their residual motor function. This is called a "body-machine interface" because it maps the motions of the upper-body (arms and shoulders) to the space of device control signals in an optimal way. In this way, paralyzed persons that cannot operate a joystick controller because of lack of hand mobility can effectively use their whole upper body as virtual joystick device. An important characteristic of the proposed approach is that it is based on the possibility to control a computer or a wheelchair by bodily movements through an interactive learning process, in which the interface adapts itself to the subject's mobility and the subject learns to act through the interface. This study aims at developing and testing the customization of this interface to a group of SCI participants with tetraplegia, resulting from high-level cervical injury. The proposed research is organized in three specific aims: (Aim 1) To develop new functional capabilities in persons with spinal cord injury by customizing a body-machine interface to their individual upper body mobility. After fitting the interface to the residual movements of each subject, participants will practice computer games aimed at training two classes of control actions: operating a virtual joystick and operating a virtual keyboard. This study will test the ability of the subjects to perform skilled maneuvers with a simulated wheelchair. (Aim 2.) To test the hypothesis that practicing the upper-body control of personalized interfaces results in significant physical and psychological benefits after spinal-cord injury. A study will evaluate and quantify the impact of the practicing functional upper-body motions on the mobility of the shoulder and arms by conventional clinical methods and by measuring the subjects' ability to generate coordinated upper body movements and to apply isometric forces. Other studies under this aim will evaluate the effects of operating the body-machine interface on musculoskeletal pain and on the mood and mental state of the participants. (Aim 3) To train spinal-cord injury survivors to skillfully operate a powered wheelchair using their enhanced upper body motor skills and customized interface parameters. Finally, the last study will test the hypothesis that the skills learned through practice in the virtual environment are retained for the control of an actual powered wheelchair. After reaching stable performance in the simulated wheelchair, subjects will practice the control of the physical wheelchair in safe a testing environment. (Aim 4.) To understand how extensive practice with a body machine interface affects the cortical representation of the trained limbs. A study will evaluate and quantify the impact of the practicing functional upper-body motions on corticospinal excitability as a correlate to sensorimotor skill learning. Participants will meet the inclusion criteria for both the main study and satisfy the additional optional criteria. Participant will practice upper-body movements using the body-machine interface. The study will evaluate the evolution of corticospinal excitability in related areas of the motor cortex during the training compared to the baseline and after a follow-up period. If successful, this study will lead to effective operation of a highly customized interface that adapts to the residual motor capability of its users. Physical and psychological benefits are expected to derive from the sustained and coordinated activity associated with the use of this body-machine interface

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Body-machine interface, Customization, Upper-body motion, Motor learning, Assistive Devices, Wheelchair, Computer keyboard

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCI Static
Arm Type
Experimental
Arm Description
SCI group that practices with a static body-machine map
Arm Title
SCI Machine Learning
Arm Type
Experimental
Arm Description
Spinal Cord Injury patients who practice with a body-machine map that is adapted using machine learning
Intervention Type
Device
Intervention Name(s)
Customizing the Body-Machine Interface
Intervention Description
The intervention compares two ways of customizing the body-machine interface which will be used for subjects for 40 sessions (spread over 8 months). In one case (SCI static), the body-machine interface is static. In the other case (SCI Machine Learning), there is a machine learning algorithm that adapts to the movements made by the subject.
Primary Outcome Measure Information:
Title
Change in Time to task completion from Baseline at 8 months
Description
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.
Time Frame
Baseline and 8 months
Secondary Outcome Measure Information:
Title
Change in Movement Smoothness from Baseline at 8 months
Description
This outcome measure measures the change in movement smoothness when operating the virtual and real wheelchairs
Time Frame
Baseline and 8 months
Title
Change in Strength
Description
This outcome measure measures the changes in upper body strength after training
Time Frame
Baseline and 8 months
Title
Change in Mental State
Description
This outcome measures measures the change in mental state (as quantified by the State-Trait Anxiety Inventory) after training
Time Frame
Baseline and 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-65 Injuries at C3-C6 level, complete (ASIA A) or incomplete (ASIA B and C) Able to follow simple commands Able to speak or respond to questions Exclusion Criteria: Presence of tremors, spasm and other significant involuntary movements Cognitive impairment Deficit of visuo-spatial orientation Concurrent pressure sores or urinary tract infection (Optional) Additional Exclusion Criteria for evaluation of corticospinal excitability using Transcranial Magnetic Stimulation: Any metal in head with the exception of dental work or any ferromagnetic metal elsewhere in the body. This applies to all metallic hardware such as cochlear implants, or an Internal Pulse Generator or medication pumps, implanted brain electrodes, and peacemaker. Personal history of epilepsy (untreated with one or a few past episodes), or treated patients Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without history of seizure, and without anticonvulsant medication Administration of drugs that potentially lower seizure threshold [62], without concomitant administration of anticonvulsant drugs which potentially protect against seizures occurrence Change in dosage for neuro-active medications (Baclophen, Lyrica, Celebrex, Cymbalta, Gapapentin, Naposyn, Diclofenac, Diazapam, Tramadol, etc) within 2 weeks of any study visit. Skull fractures, skull deficits or concussion within the last 6 months unexplained recurring headaches Sleep deprivation, alcoholism Claustrophobia precluding MRI Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferdinando A Mussa-Ivaldi, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28413945
Citation
Abdollahi F, Farshchiansadegh A, Pierella C, Seanez-Gonzalez I, Thorp E, Lee MH, Ranganathan R, Pedersen J, Chen D, Roth E, Casadio M, Mussa-Ivaldi F. Body-Machine Interface Enables People With Cervical Spinal Cord Injury to Control Devices With Available Body Movements: Proof of Concept. Neurorehabil Neural Repair. 2017 May;31(5):487-493. doi: 10.1177/1545968317693111. Epub 2017 Feb 1.
Results Reference
background
PubMed Identifier
32393288
Citation
De Santis D, Mussa-Ivaldi FA. Guiding functional reorganization of motor redundancy using a body-machine interface. J Neuroeng Rehabil. 2020 May 11;17(1):61. doi: 10.1186/s12984-020-00681-7.
Results Reference
derived

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Motor Learning in a Customized Body-Machine Interface

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