Clinical trial NCT05016193: Independent Use of Brain Measurement-Based Rehabilitation System by Stroke Survivors
Official title: Independent Use of Brain Measurement-Based Rehabilitation System by Stroke Survivors: A Randomized Open Label Phase 1 Clinical Trial With Blinded Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Rehabilitation
Neurofeedback
Functional near-infrared spectroscopy
Neuroergonomics
Motor cortex
Gamification
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Axem Neurotechnology Inc.
First posted: 2021-08-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The Axem Home study is a randomized open label trial analyzing the safety and feasibility of coupling the Axem Home prototype device with exercise to improve motor recovery following a stroke.

Detailed description: The Axem Home study is a randomized, open label, phase I clinical trial evaluating the safety and feasibility of coupling feedback to participants on their levels of sensorimotor brain activity (via the Axem Home prototype device) with exercise rehabilitation. 15 participants will be enrolled in each arm of the study. Both groups will participate in an exercise program, but only one group (the intervention group) will receive the Axem Home prototype device.

Study participants will be evaluated at baseline, after 3 weeks, and after 6 weeks (upon the completion of their time in the Early Supported Discharge program). Evaluators will be blinded as to which group participants are in. The study is constructed with randomization to remove selection and allocation biases.

Eligibility criteria: Inclusion Criteria:

* Accepted into the Calgary Stroke Program's Early Supported Discharge program for stroke survivors
* Aged 18 or older
* Visual acuity better than 20/50 in both eyes
* Able to give consent
* Clinician reported upper-extremity movement deficit

Exclusion Criteria:

* Score ≥15 on the PHQ-9
* Score \<10 on the MoCA or \<20 on the CASP
* Inclusion in another interventional trial
* Have open wounds on their scalp

Primary outcomes:
measure: Incidence of Adverse Events Related to the Axem Home Prototype Device (Safety and Tolerability)
timeFrame: Intervention group only: through study completion, an average of 6 weeks
measure: Usability Interview
timeFrame: Intervention group only: once per week for an average of 6 weeks and post-intervention (after study completion, an average of week 6)
measure: Usability Questionnaire
timeFrame: Intervention group only: post-intervention (after study completion, an average of week 6)
measure: Participation
timeFrame: Intervention group only: through study completion, an average of 6 weeks
Secondary outcomes:
measure: Change in Fugl-Meyer Assessment (FMA) of Motor Recovery
timeFrame: Baseline, week 3, and post-intervention (after study completion, an average of week 6)
measure: Change in Action Research Arm Test (ARAT) score
timeFrame: Baseline, week 3, and post-intervention (after study completion, an average of week 6)
measure: Stroke Impact Scale (SIS)
timeFrame: Baseline, week 3, and post-intervention (after study completion, an average of week 6)
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: Baseline
measure: Cognitive Assessment for Stroke Patients (CASP)
timeFrame: Baseline
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline
measure: Snellen Eye Chart Assessment of Visual Acuity
timeFrame: Baseline
measure: Clinician Assessment of Vision
timeFrame: Baseline
measure: Functional Independence Measure (FIM)
timeFrame: Baseline and post-intervention (after study completion, an average of week 6)
measure: Modified Rankin Scale (mRS)
timeFrame: Baseline and post-intervention (after study completion, an average of week 6)
measure: Thumb Localizing Test
timeFrame: Baseline and post-intervention (after study completion, an average of week 6)
measure: Strength
timeFrame: Baseline and post-intervention (after study completion, an average of week 6)
measure: Modified Ashworth Scale (MAS)
timeFrame: Baseline and post-intervention (after study completion, an average of week 6)
measure: Functional Near-Infrared Spectroscopy (fNIRS) Measures
timeFrame: Intervention group: baseline, once per week for an average of 6 weeks, and post-intervention (after study completion, an average of week 6). Control group: baseline and post-intervention (after study completion, an average of week 6)
measure: Recording of Assigned Home Exercises
timeFrame: Weekly (for an average of 6 weeks)
measure: Home Exercise Compliance
timeFrame: Weekly (for an average of 6 weeks)
measure: Video Capture
timeFrame: Intervention group only: rehabilitation sessions (for an average of 6 weeks)
measure: Magnetic Resonance Imaging (MRI)
timeFrame: Images taken from within the first week after stroke; collected during the baseline assessment
measure: Computed Tomography Scan Imaging (CT)
timeFrame: Images taken from within the first week after stroke; collected during the baseline assessment
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Calgary Stroke Program Early Supported Discharge
state: Alberta
Study officials:
affiliation: University of Calgary
name: Sean Dukelow, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mihara M, Hattori N, Hatakenaka M, Yagura H, Kawano T, Hino T, Miyai I. Near-infrared spectroscopy-mediated neurofeedback enhances efficacy of motor imagery-based training in poststroke victims: a pilot study. Stroke. 2013 Apr;44(4):1091-8. doi: 10.1161/STROKEAHA.111.674507. Epub 2013 Feb 12.