ANIMATOR - RehUP BCI Controlled Robotic Therapy vs. an Attention-based Control

Phase 2

Not yet recruiting

• Conditions: Chronic Stroke
• Interventions: Device: RehUp BCI Intervention; Other: Control Therapy

• Registration Number: NCT06538506
• Lead Sponsor: University of Calgary

Brief Summary

ANIMATOR aims to examine how BCI therapy vs. attention based control therapy can be used to treat people in the chronic phase of stroke with moderate to severe upper extremity impairment. This interventional trial has two phases: Pilot (10 consecutive days of intervention) and a Randomized Phase (24 sessions over 8 weeks).

Detailed Description

There is a large population of Canadians with chronic stroke and severely impaired upper limbs. Consultation with this population reveals individuals who are looking for treatment to improve their ability to move their arm and hand. The aim of the trial is to offer such a post-stroke neurorehabilitation solution using the RehUp brain computer interface (BCI). To do so, the investigators will harness neuroplastic mechanisms that form new connections in the brain helping the participant to move their arm and hand voluntarily outside of BCI and robotic support.

Given the potential for BCI facilitated post-stroke therapy to improve upper extremity function, the investigators will conduct a pilot trial and then a randomized controlled trial to compare the responses of the upper extremity in chronic stroke survivors to RehUp BCI controlled robotic device vs. an attention-based control comparator.

ANIMATOR is a phase 2, prospective, open label, randomized, controlled trial with blinded outcome assessment. Randomization will be centrally blocked and computerized. Participants will be randomized 1:1 BCI intervention or control.

In the Pilot phase, 10 participants will be enrolled and all allocated to the intervention arm.

In the Randomized Phase, Forty stroke survivors more than 6 months post-stroke with severe arm impairment will be recruited for this trial. Participants will complete 24 one-hour sessions (3x/wk for 8 weeks) of BCI robotic upper extremity therapy, or a control intervention. Potential participants will be identified by stroke physiatrists, neurologists and therapists working in clinics with individuals with stroke related impairment. They may also be identified through previous participation in research studies at one of the trial sites or through self-identification in response to community outreach by the investigators to local stroke recovery groups. Consent will be acquired prior to participating in the study. Participant will be screened using the Fugl-Meyer Upper Extremity (FM-UE), Modified Ashworth Scale (MAS), and Visual Acuity measures to meet inclusion criteria after they have consented to participate.

All groups will receive standard of care rehabilitation. Participants will not be blinded, but the assessor therapist will be. These therapists will complete a training session with the central site to ensure replicability between sites and assessors. Blinded assessors will never deliver either intervention in the trail.

The BCI intervention uses the VIBRAINT BCI robot. It allows participants to perform tasks in a virtual reality environment. In the VR,the participant is given a task to either focus on the motor goal (a target virtual object) or imagine motion of the paralyzed arm connected to this object while reaching to it or grasping it. Once the BCI recognizes cortical activity related to the assigned task, it sends a message to the robotic device to accomplish the desired motion, complemented by synchronous movement in Virtual Reality (VR) of the participant's avatar's arm. During the robotic-driven motion the participant imagines the movement as if it is being performed by them voluntarily. The participant will perform a series of tasks in VR focused on improving arm and hand function. These tasks will be scaled in difficulty and tailored to the participant's level of impairment. The goal is for the participant to complete as many repetitions as possible. A therapist will supervise these sessions to ensure the participant does not become too fatigued. The session will last 45 minutes.

The control intervention is completed with a therapist and focuses on three activities: passive range of motion exercises, motor imagery, and mirror therapy for 15 minutes each.

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08
• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-01
• Study First Posted: 2024-08-05
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Stroke survivors, ≥ 6 months post-stroke with severe arm impairment.
• 18 years of age of older
• Adequate language skills to be able to follow instructions
• FM-UE score 30 or less at study entry (i.e., severe arm impairment and would likely not use the stroke-affected arm in daily activities)
• Modified Ashworth Score ≦ 2
• Visual acuity 20/50 corrected (both eyes)

Exclusion Criteria

Potential participants will be excluded if they do not meet the requirements above, or:

• have neurologic history in addition to stroke (injury or disease), eg. TBI, MS, dementia
• enrollment in concurrent interventional trial
• major co-morbid illness making study completion unlikely
• contraindication to MRI (such as pacemaker, pregnancy, etc).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RehUp BCI intervention	RehUp BCI Intervention	The BCI intervention will complete 24 one hour intervention sessions (3x/week for 8 weeks).
Control Therapy	Control Therapy	Participants randomly allocated to the control therapy arm will complete 24 one hour therapy sessions (3x/week for 8 weeks).

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Upper Extremity (FM-UE)	Baseline, 4weeks, 8 weeks, 16 weeks	Change in Fugl-Meyer Upper Extremity (FM-UE) from measurement at baseline. The FM-UE is the most widely used outcome measure for upper limb stroke recovery studies.; The FM-UE is scored on a scale from 0 to 66, where 66 points indicates unimpaired motor function.

Secondary Outcome Measures

Name	Time	Method
Action Research Arm Test (ARAT)	Baseline, 4 weeks, 8 weeks, 16 weeks	Change in Action Research Arm Test (ARAT) from measurement at baseline. The ARAT will provide complimentary data on limb impairment.; The ARAT is scored on a scale from 0 to 57 points, where 57 points indicates unimpaired motor function.
Patient Health Questionnaire - Module 9 (PHQ-9)	Baseline, 4 weeks, 8 weeks, 16 weeks	Change in Patient Health Questionnaire - Module 9 (PHQ-9) from measurement at baseline. The PHQ-9 is used to screen for depression.; The PHQ-9 is a 10 question screening tool where nine of the ten items are scored on a scale from 0 to 3. The tenth item grades how difficult the first nine items make the participant's day-to-day life. A lower score indicates a lower likelihood and/or severity of depression.
EQ-5D (EuroQuol Measure of Health Status, Version 5D)	Baseline, 4 weeks, 8 weeks, 16 weeks	Change in EQ-5D (EuroQuol Measure of Health Status, Version 5D) from measurement at baseline. The EQ-5D is used to measure quality of life.; The EQ-5D scores fives areas of health on a scale of 1-5, where 1 indicates no problems and 5 indicates extreme problems.
Modified Ashworth Scale (MAS)	Baseline, 4 weeks, 8 weeks, 16 weeks	Change in Modified Ashworth Scale (MAS) from measurement at baseline. The MAS is used to assess spasticity.; The MAS is scored on a 6 point scale \[0, 1, 1+, 2, 3, 4\]. 0 indicates no increase in tone. 4 indicates the limb is rigid in flexion or extension.

Trial Locations

Locations (1)

Foothills Hospital; 🇨🇦 Calgary, Alberta, Canada