- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07236892
Towards Restoring Complex Movement After Paralysis: Algorithm Development With Healthy Participants
Restoring Complex Movement and Locomotion After Paralysis Through Collaborative Copilots: Algorithm Development With Healthy Participants
Participants will perform experiments with non-invasive activity recordings. The study will record from multiple non-invasive signal sources that reflect motor intent that may include: electroencephalography (EEG), electromyography (EMG), functional near infrared spectroscopy (fNIRS), inertial measurement units (IMUs), eye movements, pupil size, and speech. Participants will wear all or a subset of these sensors and be asked to perform, imagine, or attempt movements or speech. The recorded sensor signals will be decoded to help guide an end effector, which may be a computer, robotic arm, wheelchair, or other assistive device.
These experiments present minimal risk and participants may withdraw participation at any time for any reason. Participants may return for additional experiments if desired and to perform additional comparisons. If a participant withdraws during a comparison, another participant will be recruited to complete collection of data for that comparison.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Restoring Movement Study Coordinator
- Email: restoringmovementstudy@gmail.com
Study Locations
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California
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Los Angeles, California, United States, 90095
- Recruiting
- UCLA Neural Engineering and Computation Lab
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Contact:
- Restoring Movement Study Coordinator
- Phone Number: 310-983-3068
- Email: restoringmovementstudy@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Fluent in the English language
Exclusion Criteria:
- Neurological injury or disease that results in functional paralysis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthy Participants
Participants will perform a subset of tasks while non-invasive activity is recorded which may include EEG, EMG, IMUs, fNIRS, eye gaze, or pupillometry.
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Participants may be prompted to imagine, attempt, or perform actions while a task is being performed on a computer, robotic arm, wheelchair, or exoskeleton.
Participants may also autonomously perform actions to control each end effector.
Participants may be asked to control a cursor to acquire a target or multiple targets.
Participants may be asked to pick and place various objects, interact with articulated objects, or perform other motor tasks using a robotic manipulator.
Participants may be asked to navigate a wheelchair.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Normalized Performance
Time Frame: Usually one visit (Day 1), with possible additional study visits usually within a month.
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The normalized performance of the non-invasive assistive interface on a task.
Non-invasive signals, which may include electroencephalography, electromyography, functional near infrared spectroscopy, inertial measurements units, eye movements, pupil size, and speech are input into an algorithm that controls an end effector's movements.
The end effector, which may be a computer cursor, robotic manipulator, wheelchair, or other assistive device, is used to perform a motor task.
The normalized performance is derived from the the performance of the end effector on the motor task, reflecting the overall performance of the non-invasive assistive interface.
The minimum value is zero.
There is no maximum value, although the values are usually less than 1.
Higher is better.
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Usually one visit (Day 1), with possible additional study visits usually within a month.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jonathan Kao, PhD, UCLA Neural Engineering and Computation Lab
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-1072
- 1DP1HD121548-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
- Identifier data, along with non-invasive activity (e.g., EEG, EMG, fNIRS, IMU, eye gaze) and corresponding behavior (e.g., cursor kinematics, robotic arm joint angles, wheelchair kinematics) will be generated for participants. The species is human, format .bin (binary file), amount per experiment approximately 6 GB.
- Non-invasive activity and corresponding behavior will be preserved and shared, corresponding to nonidentifiable data collected during experiments.
- Documentation will be provided to facilitate interpretation of the data.
- Specialized tools, software, or code are not needed. The data is stored in Python, which is freely available, and can be loaded following documentation.
- No consensus standard exists. These will be custom datasets for the particular experimental tasks. All data will be de-identified before sharing.
IPD Sharing Time Frame
IPD Sharing Access Criteria
Scientific data and metadata will be archived on NICHD Data and Specimen Hub (DASH). DASH automatically assigns a digital object identifier (doi) to data files.
DASH is an NIH-controlled-access data repository. The NICHD DASH Data Access Committee reviews all requests to access DASH data and biospecimens from identity-verified requesters to determine whether the proposed use is scientifically and ethically appropriate and does not conflict with constraints or research data use limitations identified by the institutions that submitted the research data. The Recipient's institution and the Recipient must sign and agree to the terms and conditions.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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