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

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.

KITE-BCI: A brain-computer interface system for functional electrical stimulation therapy

“…Detailed clinical results from the study with sub-acute participants have been reported elsewhere. 24 In general, most participants experienced improvements in upper limb motor function. Three out of five participants demonstrated clinically significant improvements on self-reported assessments of independence, used as primary outcome measures.…”

“…We conducted two interventional studies to assess the feasibility and efficacy of BCI-FEST for upper limb rehabilitation for individuals with sub-acute (less than six months after injury) 24 and chronic (at least 24 months after injury) SCI. Participants of both studies were adults with traumatic incomplete SCI at the C4-C7 level and AIS B-D.…”

Characterizing the stimulation interference in electroencephalographic signals during brain–computer interface–controlled functional electrical stimulation therapy

“…The EEG data used for the stimulation interference analysis in this report were acquired from eight participants in two studies investigating the feasibility of delivering BCI‐FEST intervention in individuals with cervical SCI. One study included five individuals with subacute SCI 27 . The other study is ongoing, and thus far, data have been collected from three individuals with chronic SCI.…”

“…All of them had an incomplete traumatic SCI at the C4 or C5 level (B‐D AIS) 28 . The clinical scores in the subacute population 27 and the BCI performance figures from all eight participants have been reported elsewhere.…”

Preliminary evaluation of the reliability and validity of the 3D printed Toronto Rehabilitation Institute-Hand Function Test in individuals with spinal cord injury

“…This study was a sub-study conducted within two single arm interventional studies that aimed at assessing the feasibility and efficacy of EEG-Triggered Functional Electrical Stimulation Therapy for Upper Limb Rehabilitation. 22 Inclusion criteria for study 1 were: (a) traumatic SCI classified as American Spinal Injury Association Impairment Scale (AIS) B-D, (b) SCI less than six months prior to baseline assessment, (c) neurological level of injury between C4 to C7 and (d) expected length of stay of at least 80 days at the time of study initiation. The exclusion criteria were (a) history of seizure disorder not effectively managed by seizure medications, (b) an existing electrical stimulation device (e.g.…”