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EPSRC Reference: EP/D03146X/1
Title: A Novel Stimulator Implant with Sensory Feedback for Multi-Functional Restoration after Spinal Cord Injury
Principal Investigator: Craggs, Professor MD
Other Investigators:
Demosthenous, Professor A Donaldson, Professor N. de N.
Researcher Co-Investigators:
Dr SL Knight
Project Partners:
Finetech Medical Ltd Royal National Orthopaedic Hosp NHS Tr
Department: Medical Physics and Biomedical Eng
Organisation: UCL
Scheme: Standard Research (Pre-FEC)
Starts: 01 January 2006 Ends: 30 September 2009 Value (£): 534,857
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Summary on Grant Application Form
Context - Spinal cord injury causes devastating changes to many of the normal functions of the body. Paralysis of the limbs is obvious, but the accompanying loss of pelvic floor function is sometimes more debilitating. For example, the social stigma of double incontinence, the medical dangers of pressure sores and the inconvenience of spasm are serious conditions requiring long-term treatment. Ideally, neural repair and the development of a so-called cure would be the best solution, but even though this branch of science is exciting and expanding rapidly, the prospect for success is likely to be many years away. So, for the foreseeable future, other approaches to functional restoration must be pursued, particularly for the tens of thousands of patients with a chronic injury in the UK for whom a future cure may not even be an option. The most successful device for functional restoration in spinal cord injury has been the well-known Brindley implant that stimulates the motor nerves to empty the bladder. About 3000 people have been implanted with such stimulators during the last 25 years. The main disadvantage of this implant, clinically and commercially, is that some sensory nerves have to be cut to prevent incontinence, and people perceive this as an obstacle to benefiting from the cure .Rather than cutting sensory nerves, it is possible to stimulate them to prevent urinary incontinence. This is commonly known as neuromodulation. Neuromodulation also improves bowel capacity and suppresses spasm. In addition to these benefits, stimulating the motor nerves, not only gives efficient bladder and bowel emptying but also erections, and, by stimulating the gluteal muscles, reduces the likelihood of pressure sores over the buttocks. We believe that all this can be achieved with a 4-channel stimulator.The main questions for this study are: (i) can we empty the bladder and provide the other functions by stimulating the motor nerves within the spinal canal? (ii) can we use feedback from bladder sensory nerves to initiate neuromodulation when the bladder contracts? Aims - The aim of this project is to develop and make a novel multi-functional implant. This will be tested in eight volunteers with spinal cord injury so that the functions mentioned above can be assessed in the laboratory and evaluated in everyday life. The engineering and clinical testing of this device will be a necessary step towards designing a commercial system. Application & Benefits - The principal beneficiaries of this project are people with a spinal cord injury. They can be expected to achieve a level of functional restoration that will significantly improve quality of life, decrease medical complications and give greater opportunity for re-integration into society. The multi-functional implant, described here, would achieve many significant advances for the patient. Most importantly, in addition to restoring many functions, it would also preserve the sensory nerves, reflex erections and ejaculation. As a result of preserving the nerves, more people will benefit from treatment by implant. Use of the implant means that patients will have less dependence on a cocktail of pharmaceutical treatments. Best of all, this multi-functional implant would not preclude the possibility of applying a future cure.
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