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Multimodal EEG and NIRS-based BCI With Assistive Soft Robotics for Stroke (MBCI-SR) (MBCI-SR)

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
MBCI-SR
Sponsored by
Tan Tock Seng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Brain-Computer Interface; upper limb rehabilitation

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: first ever stroke prior to clinical trial Fugl-Meyer Assessment scale of upper extremity impairment of 11-45 out of a maximum score of 66 ability to give own consent ability to pay attention and maintain supported sitting for 1.5 hours continuously able to comprehend and follow commands fulfils BCI resting brain states on initial screening unilateral upper limb impairment Exclusion Criteria: recurrent stroke inability to follow command and sit upright for 1.5 hours hemi-spatial neglect spasticity assessed by Modified Ashworth Scale more than 2/4 History of Epilepsy Fixed contracture / deformity of finger joints upper limb pain impeding movements with visual analogy scale > 4/10 Severe aphasia or cognitive impairment despite visual aids other conditions ensuing upper limb weakness poor skin conditions skull defect that might affect EEG or NIRS reading allergy to electrodes or adhesive gel significant vision and hearing impairment affecting participation Pregnant women

Sites / Locations

  • Tan Tock Seng Hospital Rehabilitation CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MBCI-SR

Arm Description

BCI based robotic rehabilitation works by detecting the motor intent of the user from Electroencephalogram signals to drive rehabilitation assisted by the soft robotics gloves.

Outcomes

Primary Outcome Measures

Fugl-Meyer score of upper limb
a measure for upper extremity, movement coordination and reflex action.
Fugl-Meyer score of upper limb
a measure for upper extremity, movement coordination and reflex action.
Fugl-Meyer score of upper limb
a measure for upper extremity, movement coordination and reflex action.
Fugl-Meyer score of upper limb
a measure for upper extremity, movement coordination and reflex action.
Fugl-Meyer score of upper limb
a measure for upper extremity, movement coordination and reflex action.

Secondary Outcome Measures

Action Research Arm Test
A measure for upper extremity functioning, such as dexterity and motor coordination, the key components in performing ADLs
Action Research Arm Test
A measure for upper extremity functioning, such as dexterity and motor coordination, the key components in performing ADLs
Action Research Arm Test
A measure for upper extremity functioning, such as dexterity and motor coordination, the key components in performing ADLs

Full Information

First Posted
November 15, 2022
Last Updated
December 7, 2022
Sponsor
Tan Tock Seng Hospital
Collaborators
Institute for Infocomm Research, Nanyang Technological University
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1. Study Identification

Unique Protocol Identification Number
NCT05642299
Brief Title
Multimodal EEG and NIRS-based BCI With Assistive Soft Robotics for Stroke (MBCI-SR)
Acronym
MBCI-SR
Official Title
Multimodal EEG and NIRS-based BCI With Assistive Soft Robotics for Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
September 14, 2023 (Anticipated)
Study Completion Date
December 14, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tan Tock Seng Hospital
Collaborators
Institute for Infocomm Research, Nanyang Technological University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
One-third of patients who had stroke suffered persistent disabilities, and upper limb (UL) motor impairment is one of the main disabilities. Recent clinical studies had been conducted using non-invasive EEG-based BCI via motor imagery, for post-stroke rehabilitation, yielded motor improvement of 7.2 on the Fugl-Meyer Motor Assessment (FMA-UE)score in chronic stroke patients that is significantly better than standard care. However, all the stroke patients underwent the same "one-size-fits-all" treatment option involving all six different activities of daily living (ADL)-oriented tasks regardless of their impairment or ability. Investigators hypothesize that precision personalized stroke rehabilitation intervention that is tailored to the patient hold more promise than a "one-size-fits-all" stroke rehabilitation strategy.
Detailed Description
To address the "one-size-fits-all" stroke rehabilitation strategy, RRIS will develop an Ability data-driven personalized stroke rehabilitation based on the stroke patient's UL impairment and motor ability, by first matching 6 UL tasks in RRIS Ability Database with the 6 ADL tasks of the BCI-SR Intervention via similarity indices. A personalized subset of ADL tasks treatment options is then generated by a data-driven recommendation based on the patient's ability, movement pattern of the treatment option and the normative data from the RRIS Ability Database. A multi-modal BCI is proposed to perform EEG subject-specific calibration using Near-infrared spectroscopy, NIRS to ensure motor imagery compliance. stroke subjects with UL impairments (score 11-45 on the FMA-UE) will be recruited to undergo the UL tasks assessment at RRIS. They will then undergo the personalized stroke rehabilitation using the Multimodal EEG and NIRS-based BCI with Soft Robotic therapy for 1.5 hour over 6 weeks, 3 times a week. The effectiveness of the personalized stroke rehabilitation can then be retrospectively compared to the use of "one-size-fits-all" ADL tasks in the previous clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Brain-Computer Interface; upper limb rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MBCI-SR
Arm Type
Experimental
Arm Description
BCI based robotic rehabilitation works by detecting the motor intent of the user from Electroencephalogram signals to drive rehabilitation assisted by the soft robotics gloves.
Intervention Type
Device
Intervention Name(s)
MBCI-SR
Intervention Description
Participants will be asked to wear and EEG+NIRS cap and a soft robotic glove on their stroke-impaired hand. The participant will be instructed to ask to imagine to picture moving the stroke-imparied hand in the mind. The brain signal (EEG and NIRS data) will be recorded as a reference. When the participant pictures this move again, upon detection of such imagined move by MBCI-SR system, the glove will be activated and assists the participants to perform a specific upper limb task based on individual ability. There are six different activities of daily living (ADL)-oriented tasks enacted through a virtual arm and virtual objects, which formed the visual feedback for the participants. These tasks include scanning goods, moving an object upward to a cabinet, using two hands to move a towel, pouring of water into a cup, eating action and fine motor movement of picking up a small block using two fingers. Training intensity is 1.5 hours for 3 times a week for 6 weeks, a total of 18 sessions.
Primary Outcome Measure Information:
Title
Fugl-Meyer score of upper limb
Description
a measure for upper extremity, movement coordination and reflex action.
Time Frame
Baseline
Title
Fugl-Meyer score of upper limb
Description
a measure for upper extremity, movement coordination and reflex action.
Time Frame
at week 4 (mid point)
Title
Fugl-Meyer score of upper limb
Description
a measure for upper extremity, movement coordination and reflex action.
Time Frame
at week 6 (completion of intervention)
Title
Fugl-Meyer score of upper limb
Description
a measure for upper extremity, movement coordination and reflex action.
Time Frame
at week 12 (at 3 month post intervention)
Title
Fugl-Meyer score of upper limb
Description
a measure for upper extremity, movement coordination and reflex action.
Time Frame
at week 24 (at 6 month post intervention)
Secondary Outcome Measure Information:
Title
Action Research Arm Test
Description
A measure for upper extremity functioning, such as dexterity and motor coordination, the key components in performing ADLs
Time Frame
Baseline
Title
Action Research Arm Test
Description
A measure for upper extremity functioning, such as dexterity and motor coordination, the key components in performing ADLs
Time Frame
at week 12 (at 3 months post intervention)
Title
Action Research Arm Test
Description
A measure for upper extremity functioning, such as dexterity and motor coordination, the key components in performing ADLs
Time Frame
at week 24 ( at 6 months post intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: first ever stroke prior to clinical trial Fugl-Meyer Assessment scale of upper extremity impairment of 11-45 out of a maximum score of 66 ability to give own consent ability to pay attention and maintain supported sitting for 1.5 hours continuously able to comprehend and follow commands fulfils BCI resting brain states on initial screening unilateral upper limb impairment Exclusion Criteria: recurrent stroke inability to follow command and sit upright for 1.5 hours hemi-spatial neglect spasticity assessed by Modified Ashworth Scale more than 2/4 History of Epilepsy Fixed contracture / deformity of finger joints upper limb pain impeding movements with visual analogy scale > 4/10 Severe aphasia or cognitive impairment despite visual aids other conditions ensuing upper limb weakness poor skin conditions skull defect that might affect EEG or NIRS reading allergy to electrodes or adhesive gel significant vision and hearing impairment affecting participation Pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chloe Lauha Chung, PhD
Phone
+65 6357 8305
Email
chloe_lh_chung@ttsh.com.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Keng Ang, PhD
Phone
+65 6408 2000
Email
kkang@i2r.a-star.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chloe Lauha Chung, PhD
Organizational Affiliation
Tan Tock Seng Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kai Keng Ang
Organizational Affiliation
Institute for Infocomm Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tan Tock Seng Hospital Rehabilitation Centre
City
Singapore
ZIP/Postal Code
569766
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chloe Lauha Chung, PhD
Phone
6357 8305
Email
Chloe_lh_chung@ttsh.com.sg

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Share the study protocol, clinical study report and results
Citations:
PubMed Identifier
18835541
Citation
Daly JJ, Wolpaw JR. Brain-computer interfaces in neurological rehabilitation. Lancet Neurol. 2008 Nov;7(11):1032-43. doi: 10.1016/S1474-4422(08)70223-0. Epub 2008 Oct 2.
Results Reference
background
PubMed Identifier
24756025
Citation
Ang KK, Chua KS, Phua KS, Wang C, Chin ZY, Kuah CW, Low W, Guan C. A Randomized Controlled Trial of EEG-Based Motor Imagery Brain-Computer Interface Robotic Rehabilitation for Stroke. Clin EEG Neurosci. 2015 Oct;46(4):310-20. doi: 10.1177/1550059414522229. Epub 2014 Apr 21.
Results Reference
result
PubMed Identifier
25120465
Citation
Ang KK, Guan C, Phua KS, Wang C, Zhou L, Tang KY, Ephraim Joseph GJ, Kuah CW, Chua KS. Brain-computer interface-based robotic end effector system for wrist and hand rehabilitation: results of a three-armed randomized controlled trial for chronic stroke. Front Neuroeng. 2014 Jul 29;7:30. doi: 10.3389/fneng.2014.00030. eCollection 2014.
Results Reference
result
PubMed Identifier
32248089
Citation
Cheng N, Phua KS, Lai HS, Tam PK, Tang KY, Cheng KK, Yeow RC, Ang KK, Guan C, Lim JH. Brain-Computer Interface-Based Soft Robotic Glove Rehabilitation for Stroke. IEEE Trans Biomed Eng. 2020 Dec;67(12):3339-3351. doi: 10.1109/TBME.2020.2984003. Epub 2020 Nov 19.
Results Reference
result
PubMed Identifier
22208123
Citation
Ang KK, Guan C, Chua KS, Ang BT, Kuah CW, Wang C, Phua KS, Chin ZY, Zhang H. A large clinical study on the ability of stroke patients to use an EEG-based motor imagery brain-computer interface. Clin EEG Neurosci. 2011 Oct;42(4):253-8. doi: 10.1177/155005941104200411.
Results Reference
result

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Multimodal EEG and NIRS-based BCI With Assistive Soft Robotics for Stroke (MBCI-SR)

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