Clinical trial NCT06538506: ANIMATOR - RehUP BCI Controlled Robotic Therapy vs. an Attention-based Control
Official title: ANIMATOR - A Single-blind Randomized Controlled Trial of RehUP BCI Controlled Robotic Therapy vs. an Attention-based Control
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Chronic Stroke
Keywords: Brain Computer Interface
Robotic Therapy
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: VIBRAINT Inc.
First posted: 2024-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups for the duration of the study (BCI therapy or standard physiotherapy employing active and passive range of motion exercises).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Fugl-Meyer Upper Extremity (FM-UE)
timeFrame: Baseline, 4weeks, 8 weeks, 16 weeks
Secondary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: Baseline, 4 weeks, 8 weeks, 16 weeks
measure: Modified Ashworth Scale (MAS)
timeFrame: Baseline, 4 weeks, 8 weeks, 16 weeks
measure: Patient Health Questionnaire - Module 9 (PHQ-9)
timeFrame: Baseline, 4 weeks, 8 weeks, 16 weeks
measure: EQ-5D (EuroQuol Measure of Health Status, Version 5D)
timeFrame: Baseline, 4 weeks, 8 weeks, 16 weeks
Other outcomes:
measure: National Institute of Health Stroke Scale (NIHSS)
timeFrame: Baseline, 4 weeks, 8 weeks, 16 weeks
measure: Modified Rankin Scale (mRS)
timeFrame: Baseline, 4 weeks, 8 weeks, 16 weeks
Locations:
city: Calgary
country: Canada
facility: Foothills Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Sean P Dukelow, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: