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

NCT06538506 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: ANIMATOR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Stroke

Keywords

Brain Computer Interface; Robotic Therapy

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Upper Extremity (FM-UE)

  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.

  Baseline, 4weeks, 8 weeks, 16 weeks

Secondary Outcomes (4)

• Action Research Arm Test (ARAT)

  Baseline, 4 weeks, 8 weeks, 16 weeks

• Modified Ashworth Scale (MAS)

  Baseline, 4 weeks, 8 weeks, 16 weeks

• Patient Health Questionnaire - Module 9 (PHQ-9)

  Baseline, 4 weeks, 8 weeks, 16 weeks

• EQ-5D (EuroQuol Measure of Health Status, Version 5D)

  Baseline, 4 weeks, 8 weeks, 16 weeks

Other Outcomes (2)

• National Institute of Health Stroke Scale (NIHSS)

  Baseline, 4 weeks, 8 weeks, 16 weeks

• Modified Rankin Scale (mRS)

  Baseline, 4 weeks, 8 weeks, 16 weeks

Study Arms (2)

RehUp BCI intervention

EXPERIMENTAL

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

Device: RehUp BCI Intervention

Control Therapy

ACTIVE COMPARATOR

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

Other: Control Therapy

Interventions

RehUp BCI Intervention DEVICE

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.

RehUp BCI intervention

Control Therapy OTHER

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.

Control Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke survivors, ≥ 6 months post-stroke with severe arm impairment.
• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Calgary: lead
• VIBRAINT Inc.: collaborator

Study Sites (1)

Foothills Hospital

Calgary, Alberta, T2N2T9, Canada

Location

Study Officials

• Sean P Dukelow, MD PhD FRCPC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark A Piitz

CONTACT

(403)944-1085; robotlab@ucalgary.ca

Sean P Dukelow, MD PhD FRCPC

CONTACT

(403)944-4050; robotlab@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The outcome assessor and investigator will be blinded to participant allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 5, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)