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Brain-Computer Interface

Brain-Computer Interface Rehabilitation for Post-Stroke Motor Impairment (fNIRS-PROMOTE Trial)

Q: How many participants have been admitted to this research project?

Affirmative. Information on clinicaltrials.gov affirms that the medical trial, initially posted February 23rd 2022, is currently recruiting participants. A total of 40 individuals must be sourced from 1 centre for this study.

Q: Are researchers currently recruiting participants for this trial?

Affirmative. According to clinicaltrials.gov, this experiment is currently recruiting patients; the original post was made on February 23rd 2022 and it has been updated as recently as May 20th 2022. The trial needs 40 participants at one centre.

Q: Does this experiment accommodate participants 18 years and older?

According to the study's inclusion criteria, <a href="https://www.withpower.com/clinical-trials/all">all</a> potential participants must fall between 18 and 90 years of age. Specifically, there are 8 trials for minors under 18 and 67 clinical studies available for individuals over 65.

Q: What prerequisites must an individual meet to be eligible for this research experiment?

This clinical trial seeks 40 participants aged 18 to 90 with hemiparesis. To be eligible, patients must have experienced a <a href="https://www.withpower.com/clinical-trials/stroke">stroke</a> within the last 6 months and 5 years respectively, hold an FMA-UE score of 56 or lower, demonstrate basic obedience in English language instructions, and not be receiving therapy for their upper extremity at present.

Phase < 1

Recruiting

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

fNIRS-PROMOTE Trial Summary

This trial provides a system to aid in at-home rehabilitation for chronic stroke survivors suffering from weaknesses or movement difficulties in their hand/arm. The system includes a headband that measures and provides feedback from the brain during rehabilitation, together with tablet-based software.

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.Check my eligibility

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.See study design

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.

fNIRS-PROMOTE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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.

fNIRS-PROMOTE 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Axem Neurotechnology Inc.Lead Sponsor

1 Previous Clinical Trials

30 Total Patients Enrolled

Massachusetts General HospitalOTHER

2,928 Previous Clinical Trials

13,198,315 Total Patients Enrolled

Media Library

Axem Home (Brain-Computer Interface) Clinical Trial Eligibility Overview. Trial Name: NCT05258591 — Phase < 1

Hemiparesis Research Study Groups: Axem Home

Hemiparesis Clinical Trial 2023: Axem Home Highlights & Side Effects. Trial Name: NCT05258591 — Phase < 1

Axem Home (Brain-Computer Interface) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05258591 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been admitted to this research project?

"Affirmative. Information on clinicaltrials.gov affirms that the medical trial, initially posted February 23rd 2022, is currently recruiting participants. A total of 40 individuals must be sourced from 1 centre for this study."

Answered by AI

Are researchers currently recruiting participants for this trial?

"Affirmative. According to clinicaltrials.gov, this experiment is currently recruiting patients; the original post was made on February 23rd 2022 and it has been updated as recently as May 20th 2022. The trial needs 40 participants at one centre."

Answered by AI

Does this experiment accommodate participants 18 years and older?

"According to the study's inclusion criteria, all potential participants must fall between 18 and 90 years of age. Specifically, there are 8 trials for minors under 18 and 67 clinical studies available for individuals over 65."

Answered by AI

What prerequisites must an individual meet to be eligible for this research experiment?

"This clinical trial seeks 40 participants aged 18 to 90 with hemiparesis. To be eligible, patients must have experienced a stroke within the last 6 months and 5 years respectively, hold an FMA-UE score of 56 or lower, demonstrate basic obedience in English language instructions, and not be receiving therapy for their upper extremity at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Post-stroke Motor Rehabilitation Using Functional Near-infrared Spectroscopy-based Brain-computer-interface

2022. "Post-stroke Motor Rehabilitation Using Functional Near-infrared Spectroscopy-based Brain-computer-interface". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05258591.