Spinal stimulation in chronic spinal cord injury
Research type
Research Study
Full title
Non-invasive spinal cord stimulation combined with activity-based rehabilitation in chronic spinal cord injury
IRAS ID
254950
Contact name
Jane Symonds
Contact email
Sponsor organisation
The Neurokinex Charitable Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Research Summary
Spinal cord injury (SCI) is a devastating and debilitating condition that affects most aspects of a sufferer's life. For those with SCI, a small improvement in motor function may mean the difference between self-care dependence and independence, leading to a better quality of life and reduced lifetime costs of care.
This pilot study will evaluate the safety, tolerability and feasibility of whether transcutaneous (via the skin) spinal cord stimulation (tSCS), applied to the skin surface via a novel non-invasive system and combined with exercise therapy over a year-long period, is an acceptable and comfortable procedure that could lead to any change in voluntary function after SCI. The tSCS system has been designed to deliver tolerable, safe bursts of (low and high frequency) pulsed current to target neural structures.
Participants will be recruited from 2 UK non-NHS spinal cord injury centres.Summary of Results
Spinal cord injury (SCI) is a devastating and debilitating condition that affects most aspects of a person’s life. For those with SCI, a small improvement in motor function may mean the difference between self-care dependence and independence, leading to a better quality of life and reduced lifetime costs of care.
This pilot study evaluated the safety, tolerability, and feasibility of transcutaneous (or applied to the skin) spinal cord stimulation (tSCS). Participants with varying levels of spinal cord injury (cervical and thoracic, complete and incomplete injuries) attended 120 sessions over a year-long period for an average of 3 times per week. tSCS was applied to the skin surface via a novel non-invasive system and combined with Activity-Based Therapy (ABT) over a year-long period. The tSCS system was designed to deliver tolerable, safe bursts of (low and high frequency) pulsed current to target neural structures.
Following the conclusion of this study, tSCS has been shown to be an acceptable and comfortable intervention. The preliminary results demonstrate changes in voluntary motor and sensory function following the combination of tSCS and ABT. The tSCS and ABT intervention was tolerated for the prolonged period of time of this study. The adherence of the participants to the intensive study protocol demonstrates that this type of intervention is practical to apply in a community-based neurological rehabilitation setting. These preliminary results indicate that prolonged access to this therapy is an important factor. Statistically significant change in outcome measures was not observed until a minimum of 60 sessions. Slow and gradual improvements in outcome measures continued to be noted over the 120 sessions which did not seem to plateau at the conclusion of the study. This indicates that further access to tSCS and ABT will continue to result in improved sensory and motor function.
A relatively high intensity has previously been documented as an important factor in neurorehabilitation and this study supports that intensity is an important factor, with an average of three sessions per week completed by each participant throughout the course of the study. All interventions were completed at a Neurokinex rehabilitation facility with the research team specialised in the delivery of ABT. Treatment was therefore constantly monitored throughout the duration of the study. Participants gave volitional effort to all activities throughout the course of their participation and no issues were documented relating to lack of voluntary effort from any participant. It remains unknown if those not already accustomed to ABT (a rigorous exercise therapy) would be able to safely participate in a rehabilitation programme of this intensity. Nevertheless, the findings of this study provide evidence that transcutaneous spinal cord stimulation promotes impactful improvement in sensory and motor function in persons living with SCI.The Neurokinex Charitable Trust would like to thank the research participants and their families for their motivation, adherence, and dedication that made this study possible. Neurokinex would also like to thank NeuroRecovery Technologies Inc., now ONWARD Medical, for providing the tSCS stimulators used in this study.
REC name
London - Stanmore Research Ethics Committee
REC reference
19/LO/0039
Date of REC Opinion
18 Apr 2019
REC opinion
Further Information Favourable Opinion