Brain–computer interface-triggered functional electrical stimulation therapy for rehabilitation of reaching and grasping after spinal cord injury: a feasibility study

Study design Feasibility and preliminary clinical efficacy analysis in a single-arm interventional study. Objectives We developed a brain–computer interface-triggered functional electrical stimulation therapy (BCI-FEST) system for clinical application and conducted an interventional study to (1) ass...

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Published inSpinal cord series and cases Vol. 7; no. 1; p. 24
Main Authors Jovanovic, Lazar I., Kapadia, Naaz, Zivanovic, Vera, Rademeyer, Hope Jervis, Alavinia, Mohammad, McGillivray, Colleen, Kalsi-Ryan, Sukhvinder, Popovic, Milos R., Marquez-Chin, Cesar
Format Journal Article
LanguageEnglish
Published London Nature Publishing Group UK 19.03.2021
Nature Publishing Group
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ISSN2058-6124
2058-6124
DOI10.1038/s41394-020-00380-4

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Abstract Study design Feasibility and preliminary clinical efficacy analysis in a single-arm interventional study. Objectives We developed a brain–computer interface-triggered functional electrical stimulation therapy (BCI-FEST) system for clinical application and conducted an interventional study to (1) assess its feasibility and (2) understand its potential clinical efficacy for the rehabilitation of reaching and grasping in individuals with sub-acute spinal cord injury (SCI). Setting Spinal cord injury rehabilitation hospital—Toronto Rehabilitation Institute—Lyndhurst Centre. Methods Five participants with sub-acute SCI completed between 12 and 40 1-hour sessions using BCI-FEST, with up to 5 sessions a week. We assessed feasibility by measuring participants’ compliance with treatment, the occurrence of adverse events, BCI sensitivity, and BCI setup duration. Clinical efficacy was assessed using Functional Independence Measure (FIM) and Spinal Cord Independence Measure (SCIM), as primary outcomes. In addition, we used two upper-limb function tests as secondary outcomes. Results On average, participants completed 29.8 sessions with no adverse events. Only one of the 149 sessions was affected by technical challenges. The BCI sensitivity ranged between 69.5 and 80.2%, and the mean BCI setup duration was ~11 min. In the primary outcomes, three out of five participants showed changes greater than the minimal clinically important differences (MCIDs). Additionally, the mean change in secondary outcome measures met the threshold for detecting MCID as well; four out of five participants achieved MCID. Conclusions The new BCI-FEST intervention is safe, feasible, and promising for the rehabilitation of reaching and grasping after SCI.
AbstractList Feasibility and preliminary clinical efficacy analysis in a single-arm interventional study. We developed a brain-computer interface-triggered functional electrical stimulation therapy (BCI-FEST) system for clinical application and conducted an interventional study to (1) assess its feasibility and (2) understand its potential clinical efficacy for the rehabilitation of reaching and grasping in individuals with sub-acute spinal cord injury (SCI). Spinal cord injury rehabilitation hospital-Toronto Rehabilitation Institute-Lyndhurst Centre. Five participants with sub-acute SCI completed between 12 and 40 1-hour sessions using BCI-FEST, with up to 5 sessions a week. We assessed feasibility by measuring participants' compliance with treatment, the occurrence of adverse events, BCI sensitivity, and BCI setup duration. Clinical efficacy was assessed using Functional Independence Measure (FIM) and Spinal Cord Independence Measure (SCIM), as primary outcomes. In addition, we used two upper-limb function tests as secondary outcomes. On average, participants completed 29.8 sessions with no adverse events. Only one of the 149 sessions was affected by technical challenges. The BCI sensitivity ranged between 69.5 and 80.2%, and the mean BCI setup duration was ~11 min. In the primary outcomes, three out of five participants showed changes greater than the minimal clinically important differences (MCIDs). Additionally, the mean change in secondary outcome measures met the threshold for detecting MCID as well; four out of five participants achieved MCID. The new BCI-FEST intervention is safe, feasible, and promising for the rehabilitation of reaching and grasping after SCI.
Study design Feasibility and preliminary clinical efficacy analysis in a single-arm interventional study. Objectives We developed a brain–computer interface-triggered functional electrical stimulation therapy (BCI-FEST) system for clinical application and conducted an interventional study to (1) assess its feasibility and (2) understand its potential clinical efficacy for the rehabilitation of reaching and grasping in individuals with sub-acute spinal cord injury (SCI). Setting Spinal cord injury rehabilitation hospital—Toronto Rehabilitation Institute—Lyndhurst Centre. Methods Five participants with sub-acute SCI completed between 12 and 40 1-hour sessions using BCI-FEST, with up to 5 sessions a week. We assessed feasibility by measuring participants’ compliance with treatment, the occurrence of adverse events, BCI sensitivity, and BCI setup duration. Clinical efficacy was assessed using Functional Independence Measure (FIM) and Spinal Cord Independence Measure (SCIM), as primary outcomes. In addition, we used two upper-limb function tests as secondary outcomes. Results On average, participants completed 29.8 sessions with no adverse events. Only one of the 149 sessions was affected by technical challenges. The BCI sensitivity ranged between 69.5 and 80.2%, and the mean BCI setup duration was ~11 min. In the primary outcomes, three out of five participants showed changes greater than the minimal clinically important differences (MCIDs). Additionally, the mean change in secondary outcome measures met the threshold for detecting MCID as well; four out of five participants achieved MCID. Conclusions The new BCI-FEST intervention is safe, feasible, and promising for the rehabilitation of reaching and grasping after SCI.
Feasibility and preliminary clinical efficacy analysis in a single-arm interventional study.STUDY DESIGNFeasibility and preliminary clinical efficacy analysis in a single-arm interventional study.We developed a brain-computer interface-triggered functional electrical stimulation therapy (BCI-FEST) system for clinical application and conducted an interventional study to (1) assess its feasibility and (2) understand its potential clinical efficacy for the rehabilitation of reaching and grasping in individuals with sub-acute spinal cord injury (SCI).OBJECTIVESWe developed a brain-computer interface-triggered functional electrical stimulation therapy (BCI-FEST) system for clinical application and conducted an interventional study to (1) assess its feasibility and (2) understand its potential clinical efficacy for the rehabilitation of reaching and grasping in individuals with sub-acute spinal cord injury (SCI).Spinal cord injury rehabilitation hospital-Toronto Rehabilitation Institute-Lyndhurst Centre.SETTINGSpinal cord injury rehabilitation hospital-Toronto Rehabilitation Institute-Lyndhurst Centre.Five participants with sub-acute SCI completed between 12 and 40 1-hour sessions using BCI-FEST, with up to 5 sessions a week. We assessed feasibility by measuring participants' compliance with treatment, the occurrence of adverse events, BCI sensitivity, and BCI setup duration. Clinical efficacy was assessed using Functional Independence Measure (FIM) and Spinal Cord Independence Measure (SCIM), as primary outcomes. In addition, we used two upper-limb function tests as secondary outcomes.METHODSFive participants with sub-acute SCI completed between 12 and 40 1-hour sessions using BCI-FEST, with up to 5 sessions a week. We assessed feasibility by measuring participants' compliance with treatment, the occurrence of adverse events, BCI sensitivity, and BCI setup duration. Clinical efficacy was assessed using Functional Independence Measure (FIM) and Spinal Cord Independence Measure (SCIM), as primary outcomes. In addition, we used two upper-limb function tests as secondary outcomes.On average, participants completed 29.8 sessions with no adverse events. Only one of the 149 sessions was affected by technical challenges. The BCI sensitivity ranged between 69.5 and 80.2%, and the mean BCI setup duration was ~11 min. In the primary outcomes, three out of five participants showed changes greater than the minimal clinically important differences (MCIDs). Additionally, the mean change in secondary outcome measures met the threshold for detecting MCID as well; four out of five participants achieved MCID.RESULTSOn average, participants completed 29.8 sessions with no adverse events. Only one of the 149 sessions was affected by technical challenges. The BCI sensitivity ranged between 69.5 and 80.2%, and the mean BCI setup duration was ~11 min. In the primary outcomes, three out of five participants showed changes greater than the minimal clinically important differences (MCIDs). Additionally, the mean change in secondary outcome measures met the threshold for detecting MCID as well; four out of five participants achieved MCID.The new BCI-FEST intervention is safe, feasible, and promising for the rehabilitation of reaching and grasping after SCI.CONCLUSIONSThe new BCI-FEST intervention is safe, feasible, and promising for the rehabilitation of reaching and grasping after SCI.
Study designFeasibility and preliminary clinical efficacy analysis in a single-arm interventional study.ObjectivesWe developed a brain–computer interface-triggered functional electrical stimulation therapy (BCI-FEST) system for clinical application and conducted an interventional study to (1) assess its feasibility and (2) understand its potential clinical efficacy for the rehabilitation of reaching and grasping in individuals with sub-acute spinal cord injury (SCI).SettingSpinal cord injury rehabilitation hospital—Toronto Rehabilitation Institute—Lyndhurst Centre.MethodsFive participants with sub-acute SCI completed between 12 and 40 1-hour sessions using BCI-FEST, with up to 5 sessions a week. We assessed feasibility by measuring participants’ compliance with treatment, the occurrence of adverse events, BCI sensitivity, and BCI setup duration. Clinical efficacy was assessed using Functional Independence Measure (FIM) and Spinal Cord Independence Measure (SCIM), as primary outcomes. In addition, we used two upper-limb function tests as secondary outcomes.ResultsOn average, participants completed 29.8 sessions with no adverse events. Only one of the 149 sessions was affected by technical challenges. The BCI sensitivity ranged between 69.5 and 80.2%, and the mean BCI setup duration was ~11 min. In the primary outcomes, three out of five participants showed changes greater than the minimal clinically important differences (MCIDs). Additionally, the mean change in secondary outcome measures met the threshold for detecting MCID as well; four out of five participants achieved MCID.ConclusionsThe new BCI-FEST intervention is safe, feasible, and promising for the rehabilitation of reaching and grasping after SCI.
ArticleNumber 24
Author Kapadia, Naaz
McGillivray, Colleen
Kalsi-Ryan, Sukhvinder
Jovanovic, Lazar I.
Rademeyer, Hope Jervis
Zivanovic, Vera
Popovic, Milos R.
Alavinia, Mohammad
Marquez-Chin, Cesar
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Snippet Study design Feasibility and preliminary clinical efficacy analysis in a single-arm interventional study. Objectives We developed a brain–computer...
Feasibility and preliminary clinical efficacy analysis in a single-arm interventional study. We developed a brain-computer interface-triggered functional...
Study designFeasibility and preliminary clinical efficacy analysis in a single-arm interventional study.ObjectivesWe developed a brain–computer...
Feasibility and preliminary clinical efficacy analysis in a single-arm interventional study.STUDY DESIGNFeasibility and preliminary clinical efficacy analysis...
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pubmed
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springer
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StartPage 24
SubjectTerms 692/308/409
692/700/565/491
Anatomy
Biomedical and Life Sciences
Biomedicine
Brain-Computer Interfaces
Calibration
Electric Stimulation Therapy
Feasibility Studies
Hand Strength
Health care networks
Human Physiology
Humans
Neurochemistry
Neuropsychology
Neurosciences
Rehabilitation
Spinal cord injuries
Spinal Cord Injuries - therapy
Stroke
Title Brain–computer interface-triggered functional electrical stimulation therapy for rehabilitation of reaching and grasping after spinal cord injury: a feasibility study
URI https://link.springer.com/article/10.1038/s41394-020-00380-4
https://www.ncbi.nlm.nih.gov/pubmed/33741900
https://www.proquest.com/docview/2503047486
https://www.proquest.com/docview/2503448705
https://pubmed.ncbi.nlm.nih.gov/PMC7979732
Volume 7
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