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Behavioural Intervention
BCI-Controlled Devices for Motor Disorders
N/A
Recruiting
Led By Jose del R. Millan, PhD
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up difference between the week before versus after each intervention
Awards & highlights
Study Summary
This trial is testing whether or not a brain-computer interface (BCI) can help people with low spatial resolution differentiate patterns of activity associated with different hand movements of the same limb.
Who is the study for?
This trial is for people with certain motor disabilities (like stroke, spinal cord injury, or muscular diseases) and healthy individuals with normal vision. Participants must understand English and be able to consent. Those with serious illnesses, attention/cognitive issues preventing focus during sessions, heavy central nervous system medication, or conditions affecting EEG/EMG data collection can't join.Check my eligibility
What is being tested?
The study tests brain-computer interfaces (BCI) that read brain activity to control devices without movement. It focuses on whether neuromuscular electrical stimulation (NMES), when paired with motor imagery-based BCI, improves the differentiation of hand movement patterns in the same limb.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from EEG/EMG equipment or skin irritation from electrical stimulation devices used during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ difference between the week before versus after each intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~difference between the week before versus after each intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in fMRI activation for different imagined movements
Change in the BCI command delivery accuracy
Secondary outcome measures
Changes in electroencephalography functional connectivity
Changes in motor-evoked potential amplitude
Stability and separability of Motor Imagery features
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NMES-BCIExperimental Treatment1 Intervention
Sensory-threshold electrical stimulation is delivered to the flexors/extensors of the forearm contingent to the voluntary activation of the motor cortex by motor imagery of hand flexion/extension as detected by a closed-loop BCI.
Group II: Visual-BCIActive Control1 Intervention
Bar-based visual feedback is provided on a screen contingent to the voluntary activation of the motor cortex by motor imagery of hand flexion/extension as detected by a closed-loop BCI.
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Who is running the clinical trial?
University of Texas at AustinLead Sponsor
356 Previous Clinical Trials
81,439 Total Patients Enrolled
Jose del R. Millan, PhDPrincipal InvestigatorThe University of Texas at Austin
1 Previous Clinical Trials
32 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have another serious health condition, like a metabolic disorder.You have trouble moving and paying attention for the entire study session.You are taking strong medication that affects your brain and alertness.You have conditions that make it difficult to measure brain or muscle activity, or deliver certain types of electrical stimulation (such as skin infection, wounds, dermatitis, or metal implants under electrodes).You have regular vision or use corrective lenses.You have trouble moving because of certain health conditions like stroke, spinal cord injury, or muscle diseases.You have metal implants that could cause problems during certain medical tests like MRI and TMS.You do not have a history of brain or mental health problems.You have trouble moving because of conditions like stroke, spinal cord injury, muscle diseases, or pain disorders.
Research Study Groups:
This trial has the following groups:- Group 1: NMES-BCI
- Group 2: Visual-BCI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Movement Disorders Patient Testimony for trial: Trial Name: NCT05183152 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this medical research accept applicants over the age of fifty-five?
"This trial requires that applicants are aged between 18 and 80. For younger participants, there are 511 clinical trials available while those 65 years or older can choose from 2,937 studies."
Answered by AI
Does my profile qualify me to participate in this research study?
"This investigation is accepting 40 people with a stroke between 18 - 80 years of age. To be eligible, subjects must have motor deficits resulting from unilateral/bilateral stroke, spinal cord injury, motor neuron diseases (e.g., amyotrophic lateral sclerosis or multiple sclerosis), muscular disorders (myopathy), traumatic pain/neurological pain, movement issues (cerebral palsy) due to orthopedic trauma or brain tumors; they also need to possess normal vision and general good health as well as having no prior neurological or psychiatric ailments. Moreover, applicants should comprehend English since Research Personnel do not converse in Spanish and are"
Answered by AI
Is it currently possible for participants to join this clinical investigation?
"Per clinicaltrials.gov, this trial is not currently seeking patients. Initially posted on June 16th 2021 and most recently adjusted November 17th 2022, the study has suspended recruitment for now - though 3976 other trials remain open to participants at this moment in time."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
The University of Texas at Austin
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
How long do screening visits take? If accepted, how often, and how long are the visits?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I have limited hand function which has kept me from performing my occupation at my previous level of competency.(I teach cosmetology). This trial looks like it could help me regain more function. Please consider my application!
PatientReceived 1 prior treatment
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