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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Severe quadriparesis
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new technology called Neuralis that helps people with severe muscle and nerve problems control their wheelchair using their brain signals. The study wants to see if Neuralis is safe, practical,
Who is the study for?
This trial is for individuals with severe paralysis due to conditions like Multiple Sclerosis, Spinal Cord Injury, or ALS. Participants must be able to attend all tests, give consent, speak English fluently, and have a study partner. It's not suitable for those who can't use the device properly.
What is being tested?
The EMPOWER study is testing Neuralis, a non-invasive brain-computer interface (BCI) that allows people with paralysis to control their wheelchairs using EEG signals from their visual cortex by focusing their attention.
What are the potential side effects?
Since this technology is non-invasive and involves wearing an EEG headset for wheelchair control, side effects may include discomfort at the sensor sites on the scalp or fatigue from concentration required to operate the device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe weakness in all four limbs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Device safety and efficacy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patient Group / ArmExperimental Treatment1 Intervention
Use of non-invasive EEG headband device
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Who is running the clinical trial?
Synaptrix Labs Inc.Lead Sponsor
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