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

NCT06538506 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-09

No results posted yet for this study

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).

Conditions

  • Chronic Stroke

Interventions

DEVICE

RehUp BCI Intervention

Participants will be seated wearing a cap on their head containing surface electrodes connected to a computer/laptop. The laptop employs machine learning algorithms and uses the scalp electroencephalogram (EEG) signals from the scalp's surface to control a robotic arm which supports the patient's stroke-affected arm. The machine learning algorithms rapidly interpret EEG signals and adjust the outgoing movement commands to the robot based on an individual's responses to stimuli. The participant will be wearing a VR headset. The VR displays visual stimulus in time with the robotic arm. Based on information from the EEG, the participant is able to animate their robotic arm and receive visual task-based feedback in the VR.

OTHER

Control Therapy

The study therapist will focus on 3 activities (\~15 minutes each/session): passive range of motion exercises, motor imagery, and mirror therapy. These activities were chosen as they are all passive activities that are commonly used in a patient with severe impairment of the post-stroke arm and hand. Each session will last \~1hour including set up and switching between activities.

Sponsors & Collaborators

  • VIBRAINT Inc.

    collaborator UNKNOWN

  • University of Calgary

    lead OTHER

Principal Investigators

  • Sean P Dukelow, MD PhD FRCPC · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06538506 on ClinicalTrials.gov