Aref-Ali Gharooni1,2, Krishnan Padmakumari Sivaraman Nair1, Debby Hawkins1, Ian Scivill1, Daniel Hind2, Ram Hariharan3. 1. Princess Royal Spinal Injuries Centre, Sheffield Teaching Hospitals, Sheffield, UK. 2. Clinical Trials Research Unit, University of Sheffield, Regent Court, 30 Regent Court, Sheffield, S1 4DA, UK. 3. Princess Royal Spinal Injuries Centre, Sheffield Teaching Hospitals, Sheffield, UK. ram.hariharan@sth.nhs.uk.
Abstract
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.
RCT Entities:
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.
Authors: J D Steeves; D Lammertse; A Curt; J W Fawcett; M H Tuszynski; J F Ditunno; P H Ellaway; M G Fehlings; J D Guest; N Kleitman; P F Bartlett; A R Blight; V Dietz; B H Dobkin; R Grossman; D Short; M Nakamura; W P Coleman; M Gaviria; A Privat Journal: Spinal Cord Date: 2006-12-19 Impact factor: 2.772
Authors: Nicholas D James; Katalin Bartus; John Grist; David L H Bennett; Stephen B McMahon; Elizabeth J Bradbury Journal: J Neurosci Date: 2011-12-14 Impact factor: 6.167
Authors: Aref-Ali Gharooni; Brian K Kwon; Michael G Fehlings; Timothy F Boerger; Ricardo Rodrigues-Pinto; Paul Aarne Koljonen; Shekar N Kurpad; James S Harrop; Bizhan Aarabi; Vafa Rahimi-Movaghar; Jefferson R Wilson; Benjamin M Davies; Mark R N Kotter; James D Guest Journal: Global Spine J Date: 2022-02