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Brain-Computer Interface
Brain-Computer Interface Rehabilitation for Post-Stroke Motor Impairment (fNIRS-PROMOTE Trial)
Phase < 1
Waitlist Available
Research Sponsored by Axem Neurotechnology Inc.
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 10 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial involves a home-based rehabilitation program for chronic stroke survivors who have trouble moving their hands or arms. The program uses a special headband to monitor brain activity and a tablet app to guide exercises. The goal is to improve movement abilities by providing real-time feedback from the brain during exercises.
Who is the study for?
This trial is for chronic stroke survivors aged 18-90, who are 6 months to 5 years post-stroke and have arm/hand movement difficulties. They should be able to understand simple commands and speak English. Those with severe visual impairments, cognitive issues (MoCA score ≥10), pre-stroke disabilities, scalp wounds, or hair/head coverings that interfere with the device cannot participate.
What is being tested?
The study tests a home rehabilitation system called Axem Home for six weeks on stroke survivors with hand/arm paresis. It includes a brain-activity feedback headband and tablet software. The impact on motor skills and brain function will be assessed during the trial and one month after completion.
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort from wearing the headband or frustration if difficulty using the technology occurs. There could also be fatigue from regular use of the rehabilitation exercises.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Determine when in the course of the study (if at all) fNIRS data contains predictive information regarding the likelihood that participants would respond to at-home BCI rehabilitation.
Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.
Secondary study objectives
Determine whether participants can learn to modulate motor cortex brain activity during at-home BCI rehabilitation using a prototype wireless fNIRS device.
If any of primary objectives 1-4 are met, show that the improvements in function achieved by responders to at-home BCI rehabilitation is maintained after the at-home BCI rehabilitation is discontinued.
If secondary objective 1 is met, determine whether learning to modulate motor cortex brain activity during at-home BCI rehabilitation increases the likelihood of benefitting from at-home BCI rehabilitation.
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: Axem HomeExperimental Treatment1 Intervention
Patients receive at-home access to Axem Home system for duration of the study period.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for hemiparesis, such as neurofeedback headbands and tablet-based rehabilitation software, work by promoting neuroplasticity and enhancing motor learning. Neurofeedback provides real-time monitoring and feedback of brain activity, helping patients to retrain their brain to improve motor control.
Tablet-based rehabilitation software engages patients in repetitive, task-specific exercises that enhance coordination and motor skills. These mechanisms are crucial for hemiparesis patients as they can lead to significant improvements in motor function, independence, and overall quality of life.
The Effect of Biofeedback on the Motor- Muscular Situation in Rehabilitation of Stroke Patients: a Randomized Controlled Trial.Effectiveness and neural mechanisms of home-based telerehabilitation in patients with stroke based on fMRI and DTI: A study protocol for a randomized controlled trial.
The Effect of Biofeedback on the Motor- Muscular Situation in Rehabilitation of Stroke Patients: a Randomized Controlled Trial.Effectiveness and neural mechanisms of home-based telerehabilitation in patients with stroke based on fMRI and DTI: A study protocol for a randomized controlled trial.
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Who is running the clinical trial?
Axem Neurotechnology Inc.Lead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
Massachusetts General HospitalOTHER
3,006 Previous Clinical Trials
13,307,242 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to score at least 10 on the Montreal Cognitive Assessment (MoCA) test.You had a major physical disability before your most recent stroke.You have any cuts or open sores on your scalp.You must be between 18 and 90 years old.You had a stroke between 6 months and 5 years ago.Your ability to move your arms and hands is limited, with a score of 56 or lower on a specific test.You have trouble seeing that would make it difficult to use the therapy interface.
Research Study Groups:
This trial has the following groups:- Group 1: Axem Home
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.
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