Axem Home for Hemiparesis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hemiparesis+1 More
Axem Home - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Hemiparesis

Treatment Effectiveness

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 10 weeks

10 weeks
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.
6 weeks
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 participants can learn to modulate motor cortex brain activity during at-home BCI rehabilitation using a prototype wireless fNIRS device.
Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.
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.

Trial Safety

Trial Design

1 Treatment Group

Axem Home
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Axem Home · No Placebo Group · Phase < 1

Axem Home
Device
Experimental Group · 1 Intervention: Axem Home · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 10 weeks

Who is running the clinical trial?

Axem Neurotechnology Inc.Lead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,679 Previous Clinical Trials
30,832,183 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had a stroke within the past 6 months.
You are able to communicate in English.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: November 8th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.