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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 immediately after each intervention session and one-day after all sessions
Awards & highlights
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 ~ immediately after each intervention session and up to one week after all sessions
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after each intervention session and up to one week after all sessions
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the BCI command delivery performance
Change in the focality and Strength of SMR Modulation
Secondary outcome measures
Change in focality of fMRI activation for different imagined movements
Changes in electroencephalography functional connectivity
Changes in motor-evoked potential amplitude
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: TESS BCI - Standard MI TaskExperimental Treatment2 Interventions
Transcutaneous Electrical Spinal Stimulation (TESS) is applied for 20 minutes prior to BCI training sessions. Following TESS, BCI training is performed with visual feedback contingent to motor imagery as detected by a closed-loop BCI.
Group II: NMES BCI - Difficult MI TaskExperimental Treatment1 Intervention
BCI training is performed with NMES instead of Visual feedback. NMES is delivered over the flexors/extensors of the forearm contingent to the imagination of same-hand wrist and fingers flexion versus extension as detected by a closed-loop BCI.
Group III: Visual BCI - Standard MI TaskActive Control1 Intervention
Conventional BCI training is performed with visual feedback contingent to the imagination of right versus left hand movements as detected by a closed-loop BCI.
Group IV: Visual BCI - Difficult MI TaskActive Control1 Intervention
Conventional BCI training is performed with visual feedback contingent to the imagination of same-hand wrist and fingers flexion versus extension as detected by a closed-loop BCI.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Visual Feedback
2016
N/A
~420
Find a Location
Who is running the clinical trial?
University of Texas at AustinLead Sponsor
359 Previous Clinical Trials
81,653 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
276 Patients Enrolled for Multiple Sclerosis
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: TESS BCI - Standard MI Task
- Group 2: Visual BCI - Standard MI Task
- Group 3: NMES BCI - Difficult MI Task
- Group 4: Visual BCI - Difficult MI Task
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.
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT05183152 — N/A
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