Kelly A Hawkins1, Louis A DeMark2, Arian Vistamehr2, Hannah J Snyder2, Christy Conroy2, Clayton Wauneka2, Geneva Tonuzi2, David D Fuller1, David J Clark3,4, Emily J Fox5,6. 1. Department of Physical Therapy, University of Florida, Gainesville, FL, USA. 2. Brooks Rehabilitation, Jacksonville, FL, USA. 3. Brain Rehabilitation Research Center of Excellence, North Florida/South Georgia Veterans Health System, Gainesville, FL, USA. 4. Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA. 5. Department of Physical Therapy, University of Florida, Gainesville, FL, USA. ejfox@phhp.ufl.edu. 6. Brooks Rehabilitation, Jacksonville, FL, USA. ejfox@phhp.ufl.edu.
Abstract
STUDY DESIGN: Feasibility study, consisting of random-order, cross-over study of a single intervention session, followed by a parallel-arm study of 16 sessions. OBJECTIVES: To investigate the feasibility of a novel combinatorial approach with simultaneous delivery of transcutaneous spinal direct current stimulation (tsDCS) and locomotor training (tsDCS + LT) after spinal cord injury, compared to sham stimulation and locomotor training (sham + LT), and examine preliminary effects on walking function. SETTING: Clinical research center in the southeastern United States. METHODS: Eight individuals with chronic incomplete spinal cord injury (ISCI) completed the two-part protocol. Feasibility was assessed based on safety (adverse responses), tolerability (pain, spasticity, skin integrity), and protocol achievement (session duration, intensity). Walking function was assessed with the 10 m and 6 min walk tests. RESULTS: There were no major adverse responses. Minimal reports of skin irritation and musculoskeletal pain were consistent between groups. Average training peak heart rate as percent of maximum (mean(SD); tsDCS + LT: 66 (4)%, sham + LT: 69 (10)%) and Borg ratings of perceived exertion (tsDCS + LT: 17.5 (1.2), sham + LT: 14.4 (1.8)) indicate both groups trained at high intensities. Walking speed gains exceeded the minimal clinically important difference (MCID) in three of four who received tsDCS + LT (0.18 (0.29) m/s) and one of four in sham + LT (-0.05 (0.23) m/s). Gains in walking endurance exceeded the MCID in one of four in each group (tsDCS + LT: 36.4 (69.0) m, sham + LT: 4.9 (56.9) m). CONCLUSIONS: Combinatorial tsDCS and locomotor training is safe and feasible for individuals with chronic ISCI, even those with considerable walking impairment. Study outcomes support the need to investigate the efficacy of this approach.
STUDY DESIGN: Feasibility study, consisting of random-order, cross-over study of a single intervention session, followed by a parallel-arm study of 16 sessions. OBJECTIVES: To investigate the feasibility of a novel combinatorial approach with simultaneous delivery of transcutaneous spinal direct current stimulation (tsDCS) and locomotor training (tsDCS + LT) after spinal cord injury, compared to sham stimulation and locomotor training (sham + LT), and examine preliminary effects on walking function. SETTING: Clinical research center in the southeastern United States. METHODS: Eight individuals with chronic incomplete spinal cord injury (ISCI) completed the two-part protocol. Feasibility was assessed based on safety (adverse responses), tolerability (pain, spasticity, skin integrity), and protocol achievement (session duration, intensity). Walking function was assessed with the 10 m and 6 min walk tests. RESULTS: There were no major adverse responses. Minimal reports of skin irritation and musculoskeletal pain were consistent between groups. Average training peak heart rate as percent of maximum (mean(SD); tsDCS + LT: 66 (4)%, sham + LT: 69 (10)%) and Borg ratings of perceived exertion (tsDCS + LT: 17.5 (1.2), sham + LT: 14.4 (1.8)) indicate both groups trained at high intensities. Walking speed gains exceeded the minimal clinically important difference (MCID) in three of four who received tsDCS + LT (0.18 (0.29) m/s) and one of four in sham + LT (-0.05 (0.23) m/s). Gains in walking endurance exceeded the MCID in one of four in each group (tsDCS + LT: 36.4 (69.0) m, sham + LT: 4.9 (56.9) m). CONCLUSIONS: Combinatorial tsDCS and locomotor training is safe and feasible for individuals with chronic ISCI, even those with considerable walking impairment. Study outcomes support the need to investigate the efficacy of this approach.