BCI Therapy for Stroke

(ANIMATOR Trial)

Overseen By Sean P Dukelow, MD PhD FRCPC

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Calgary

Disqualifiers: TBI, MS, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 39

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how BCI therapy, which uses brain-computer interface technology, can assist people who have had a stroke and continue to struggle with severe arm movement issues. Researchers compare it to a standard attention-based therapy to determine which is more effective. Participants will join either the RehUp BCI Intervention group or a control therapy group, attending 24 sessions over eight weeks. This trial suits stroke survivors who have experienced significant arm problems for at least six months and find it difficult to use the affected arm in daily life. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the RehUp BCI Intervention is safe for stroke patients?

Research has shown that brain-computer interface (BCI) therapy, such as the RehUp BCI Intervention, is safe for aiding stroke recovery. Studies have found that patients can undergo BCI training without major safety concerns, making it a promising method for helping stroke patients regain movement.

Earlier trials consistently showed that BCI therapy does not cause serious side effects, and most patients tolerate it well. While minor side effects may occur, they are typically manageable. The treatment remains under study to confirm these findings, but current data is encouraging. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the RehUp BCI intervention for stroke recovery because it taps into brain-computer interface (BCI) technology, a cutting-edge approach not commonly used in conventional stroke therapy. Unlike standard rehabilitation methods that focus on physical exercises, this treatment uses BCI to directly engage and retrain the brain's neural pathways, potentially enhancing neuroplasticity and recovery. The technology offers a novel way to aid the brain in regaining control over motor functions, offering hope for improved outcomes in stroke rehabilitation.

What evidence suggests that the RehUp BCI intervention is effective for stroke recovery?

This trial will compare the RehUp BCI intervention with a control therapy. Studies have shown that Brain-Computer Interface (BCI) therapy can improve movement in stroke patients. Research indicates that BCI treatments, such as the RehUp BCI program, help the brain and muscles collaborate more effectively. A review of studies found that BCI-based rehabilitation successfully improves movement after a stroke. Specifically, one study showed that using BCI with motor imagery (imagining movement) enhances arm and hand function in individuals with stroke-related difficulties. Overall, BCI therapy shows promise for aiding movement recovery after a stroke. ^{1 4 6 7 8}

Who Is on the Research Team?

Sean P Dukelow, MD PhD FRCPC

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

The ANIMATOR trial is for individuals in the chronic phase of stroke recovery who have moderate to severe difficulty moving their arms. Specific details about who can join or reasons someone might not be eligible are not provided.

Inclusion Criteria

Adequate language skills to be able to follow instructions

My arm is severely impaired from a stroke, affecting daily use.

Modified Ashworth Score ≦ 2

Exclusion Criteria

I have a history of neurological conditions like stroke, TBI, MS, or dementia.

Enrollment in concurrent interventional trial

Major co-morbid illness making study completion unlikely

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pilot

10 consecutive days of intervention for initial testing of BCI therapy

2 weeks

10 visits (in-person)

Randomized Treatment

Participants receive either BCI robotic therapy or control therapy over 8 weeks

8 weeks

24 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• RehUp BCI Intervention

Trial Overview

This study compares two types of therapy: RehUp BCI, which uses brain-computer interface technology, and a control therapy that requires attention but doesn't use BCI. Participants will first go through a pilot phase followed by randomized sessions over 8 weeks.

How Is the Trial Designed?

Group I: RehUp BCI intervention Experimental Treatment 1 Intervention

The BCI intervention will complete 24 one hour intervention sessions (3x/week for 8 weeks).

Group II: Control Therapy Active Control 1 Intervention

Participants randomly allocated to the control therapy arm will complete 24 one hour therapy sessions (3x/week for 8 weeks).

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

VIBRAINT Inc.

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

Brain-computer interface (BCI) training significantly improves motor function recovery in stroke patients, with a standardized mean difference (SMD) of 0.39 for upper extremity recovery and 0.41 for lower extremity recovery compared to conventional therapy alone, based on a meta-analysis of 14 studies involving 362 patients.

BCI training also enhances brain function recovery, showing a strong effect with an SMD of 1.11, indicating its potential as a valuable addition to rehabilitation strategies for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of brain-computer interface training based on non-invasive electroencephalography using motor imagery on functional recovery after stroke - a systematic review and meta-analysis. Kruse, A., Suica, Z., Taeymans, J., et al.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12383906/

Brain-Computer Interfaces for Stroke Motor Rehabilitation - PMC

Analyses of BCI-FES interventions have shown that this type of training leads to improved motor function, greater efficiency of cortical ...

2.

iopscience.iop.org

iopscience.iop.org/article/10.1088/1741-2552/aba162

BCI for stroke rehabilitation: motor and beyond

In this paper, we review the recent advances in BCI-based post-stroke motor rehabilitation and highlight the potential for the use of BCI ...

3.

frontiersin.org

frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2023.1117670/full

Motor imagery brain–computer interface rehabilitation ...

The findings demonstrate that MI-BCI rehabilitation training could more effectively improve motor function after upper limb motor dysfunction after stroke.

4.

jneuroengrehab.biomedcentral.com

jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-021-00820-8

Brain–computer interface robotics for hand rehabilitation after ...

We report the first systematic examination of the literature on the use of BCI-robot systems for the rehabilitation of fine motor skills associated with hand ...

5.

cureus.com

cureus.com/articles/421351-brain-computer-interfaces-in-the-rehabilitation-of-stroke-and-spinal-cord-injury-a-systematic-review-and-meta-analysis-of-clinical-efficacy

Brain-Computer Interfaces in the Rehabilitation of Stroke ...

This systematic review and meta-analysis demonstrate that BCI-based rehabilitation is an effective and clinically meaningful intervention for ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03611855

Chronic Stroke Rehabilitation With Contralesional Brain- ...

The purpose of this research study is to show that a computer can analyze brain waves and that those brain waves can be used to control an external device.

7.

withpower.com

withpower.com/trial/phase-2-stroke-chronic-7-2024-12548

BCI Therapy for Stroke (ANIMATOR Trial)

The RehUp BCI Intervention is unique because it uses brain-computer interface (BCI) technology to help stroke patients regain motor function by directly ...

8.

rehab.jmir.org

rehab.jmir.org/2025/1/e71789

Recommendations for Combining Brain-Computer Interface ...

Objective: This study aims to develop recommendations for BCI interventions using task specificity and ecological validity through simulated VR ...