Intermittent theta-burst stimulation for upper-limb dysfunction and spasticity in spinal cord injury: a single-blind randomized feasibility study

Study design Single-blind, sham-controlled, crossover randomized feasibility study Objectives (1) Assess the feasibility of a full-scale trial of intermittent theta-burst stimulation (iTBS) for upper-limb sensorimotor dysfunction following spinal cord injury (SCI). (2) Determine the safety and tolerability of iTBS over primary motor cortex on upper-limb function in people with spinal cord injury (SCI). Setting Large Tertiary Spinal Injuries Centre Methods Participants with incomplete SCI, suffering with upper-limb spasticity were recruited and randomized to receive active/sham iTBS over the hand representation of the primary motor cortex. The intervention was delivered in 10 sessions over a 2-week period, followed by a 2-week washout, before being crossed over to receive the alternative intervention for the same number of sessions. Feasibility was assessed by pre-specified criteria which included recruitment rate of 3 participants per month, 10 completed interventions and 10 complete data sets for 15 recruited participants with no serious adverse events. Secondary outcomes included preliminary data collection for spasticity, pain and sensorimotor function. Results Twelve participants were recruited over 10 weeks (i.e., 4.8 per month), with 11 randomized and 10 completing the intervention protocol with no serious adverse events. Eight complete data sets were obtained as two participants failed to attend follow-up. Data from 10 participants were analyzed, with one early dropout due to an unrelated adverse event. Conclusions It is safe and feasible to conduct a full-scale trial. Whilst iTBS has shown promising results, further research optimizing the intervention is required to improve anticipated clinical efficacy.