TCES for Upper Limb Function in Cervical SCI
Key facts
- Who runs it
- University of Leeds
- Where
- United Kingdom1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 5 people enrolled
- Started
- 13 Jun 2022
- Ended
- 1 May 2024
- Type of study
- Interventional
- Treatments tested
- SCONE
- Record updated
- 20 June 2024
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 25 criteriaShow less
Who can take part
- Cervical (between C3 and C7) spinal cord injury at least 1 year prior to the study
- Between 18 and 80 years of age
- Difficulty with hand functions in activities of daily living (e.g. dressing, grooming, feeding)
- Stable medical condition without cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities
- Capable of performing simple cued motor tasks such as reaching and touching or grasping objects
- Ability to attend 3 sessions of weekly experimental sessions and testing activities over the course of 8 weeks
- Ability to provide informed consent (either verbally or in writing)
- Ability to read/speak English
Who cannot take part
- Botulinum toxin injections in the prior 6 months
- Implanted stimulator (e.g. vagus nerve stimulator, pacemaker, cochlear implant, etc) 0r infusion device (e.g. insulin pump, etc)
- Alcohol and/or drug abuse
- History of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, etc
- Rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
- Active cancer
- Cardiovascular or pulmonary disease that would prevent full participation in the upper limb practice intervention
- Ongoing medical complications (such as unhealed fracture, contracture, pressure sore, or urinary tract infection or other illnesses) that might interfere with upper extremity rehabilitation or testing activities
- Any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician
- Personal or familial history of epilepsy
- Cardiac pacemaker or intracardial lines. Exclusions for general safety
- Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
- Pregnancy
- Dependent on ventilation support
- Pregnancy
- Unable to read and/or comprehend the consent form
- Unable to understand the instructions given as part of the study
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Following a cervical spinal cord injury (cSCI; damage to the spinal cord at the neck) there is catastrophic loss of hand and grip function. This has a devastating effect on quality of life and functional independence. Thus, there is a real need to identify and optimise therapy to aid functional arm and hand recovery. One such therapy is Transcutaneous Electrical Stimulation (tCES). This involves applying sticky pads to the skin and then transmitting a low-level electrical current to the spinal cord. This activates neural circuits, allowing injured nerves to transmit signals to muscles to produce movement while completing upper limb tasks. The purpose of this pilot project is to establish if and how tCES might be used to improve arm and hand control. The investigators will recruit 8 people who have had a cSCI for >1yr. First, the investigators will invite volunteers to the University for 2 weeks, twice per week, to establish their baseline movement capacity.
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Then the investigators will allocate the volunteers to one of two groups: group 1 will undertake 4 weeks of upper limb task practice (ULTP) followed by 4 weeks of ULTP+tCES; group 2 will undertake ULTP+tCES for 4 weeks followed by 4 weeks of ULTP. Participants will then complete a week (2 sessions) of post-intervention assessment. The investigators will then invite volunteers and carers to be interviewed about their experiences of being involved in the project. Finally, there will be 2 sessions of follow-up assessment after 3 months. In order to assess if and how ULTP+tCES affects arm and hand control the investigators will measure: movement capacity using standard clinical tests; muscular activity in response to brain/spinal stimulation; how fast and smooth movements are when reaching and grasping objects. The investigators will also examine how the intervention has affected Quality of Life (QoL) and independence (Spinal Cord Independence Measure).
The group in the trial
- Upper limb task practice with or without cervical transcutaneous electrical stimulationTreatment being tested
Task specific practice will be combined with cervical transcutaneous electrical stimulation.
Treatment: SCONE
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Effects of Transcutaneous Electrical Stimulation on Arm Functions in Individuals With Cervical Spinal Cord Injury.
- Record updated
- 20 June 2024