What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for hemiparesis, such as neurofeedback and motor learning-based rehabilitation, generally have mild side effects. For instance, functional electrical stimulation (FES) may cause skin irritation or discomfort at the electrode site. Transcranial magnetic stimulation (TMS) can lead to mild headaches, scalp discomfort, or tingling sensations. Overall, these treatments are well-tolerated, with serious adverse events being rare.

What prior FDA approvals exist?

The FDA has approved several neuromodulation devices for the treatment of conditions similar to hemiparesis, such as stroke rehabilitation. These include transcranial magnetic stimulation (TMS) and vagus nerve stimulation (VNS), which have shown efficacy in improving motor function and reducing symptoms in patients with neurological impairments. Additionally, devices like functional electrical stimulation (FES) are used to enhance motor recovery by stimulating muscles and nerves. While specific approvals for a neurofeedback headband and tablet-based rehabilitation software are not detailed, these technologies align with the broader category of neuromodulation and biofeedback therapies that are gaining traction in neurorehabilitation.

What other types of research exist?

Promising alternatives for hemiparesis treatment in 2024 include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in improving motor function post-stroke. 2) Transcranial Direct Current Stimulation (tDCS), which has been effective in enhancing neurocognition and motor recovery. 3) Functional Electrical Stimulation (FES), which aids in muscle re-education and motor function improvement. 4) Brain-Computer Interface (BCI) systems, which facilitate motor recovery through direct brain activity feedback.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

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.

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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.