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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the RehUp BCI Intervention treatment for stroke?

Research shows that brain-computer interface (BCI) training can help improve motor function in stroke patients. Studies have found that BCI training, especially when combined with other therapies like functional electrical stimulation, can lead to significant improvements in arm movement and daily activities. ^{1 2 3 4 5}

What makes the RehUp BCI Intervention treatment unique for stroke patients?

The RehUp BCI Intervention is unique because it uses brain-computer interface (BCI) technology to help stroke patients regain motor function by directly connecting brain signals to a computer, which is different from traditional physical therapy that relies on physical exercises alone. ^{6 7 8 9 10}

What is the purpose of this trial?

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).

Research Team

Sean P Dukelow, MD PhD FRCPC

Principal Investigator

University of Calgary

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England 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. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Initial constructs for patient-centered outcome measures to evaluate brain-computer interfaces. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Investigating the impact of feedback update interval on the efficacy of restorative brain-computer interfaces. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Evidence of neuroplasticity with brain-computer interface in a randomized trial for post-stroke rehabilitation: a graph-theoretic study of subnetwork analysis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effects of Action Observational Training Plus Brain-Computer Interface-Based Functional Electrical Stimulation on Paretic Arm Motor Recovery in Patient with Stroke: A Randomized Controlled Trial. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Strategies for bioremediation of polychlorinated biphenyls. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

In-Situ Remediation Approaches for the Management of Contaminated Sites: A Comprehensive Overview. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Dementia as a neuropsychological consequence of chronic occupational exposure to polychlorinated biphenyls (PCBs). [2003]

9. United States pubmed.ncbi.nlm.nih.gov

SITE demonstration of the CF systems organic extraction process. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Overview of in situ and ex situ remediation technologies for PCB-contaminated soils and sediments and obstacles for full-scale application. [2017]