Lazar I Jovanovic1,2,3, Naaz Kapadia4,5,6, Vera Zivanovic4, Hope Jervis Rademeyer4,6, Mohammad Alavinia4, Colleen McGillivray7,8, Sukhvinder Kalsi-Ryan4,6, Milos R Popovic9,4,5,6, Cesar Marquez-Chin9,4,5. 1. Institute of Biomedical Engineering, University of Toronto, Toronto, ON, Canada. lazar.jovanovic@mail.utoronto.ca. 2. The KITE Research Institute, Toronto Rehabilitation Institute, University Health Network, Toronto, ON, Canada. lazar.jovanovic@mail.utoronto.ca. 3. CRANIA, University Health Network, Toronto, ON, Canada. lazar.jovanovic@mail.utoronto.ca. 4. The KITE Research Institute, Toronto Rehabilitation Institute, University Health Network, Toronto, ON, Canada. 5. CRANIA, University Health Network, Toronto, ON, Canada. 6. Rehabilitation Sciences Institute, University of Toronto, Toronto, ON, Canada. 7. Toronto Rehabilitation Institute, University Health Network, Toronto, ON, Canada. 8. Department of Medicine, Division of Physical Medicine and Rehabilitation, University of Toronto, Toronto, ON, Canada. 9. Institute of Biomedical Engineering, University of Toronto, Toronto, ON, Canada.
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.
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.
Authors: Naaz M Kapadia; Vera Zivanovic; Julio C Furlan; B Cathy Craven; Colleen McGillivray; Milos R Popovic Journal: Artif Organs Date: 2011-03 Impact factor: 3.094
Authors: Sukhvinder Kalsi-Ryan; Dorcas Beaton; Armin Curt; Milos R Popovic; Mary C Verrier; Michael G Fehlings Journal: J Spinal Cord Med Date: 2014-09 Impact factor: 1.985
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