Testing a novel home-based approach for strengthening motor pathways

Strengthening residual motor pathways in individuals with spinal cord injury

Registry ID
ISRCTN14598016
Source registry
ISRCTN
Status
Recruiting
Phase
PHASE1_PHASE2
Study type
INTERVENTIONAL
Sponsor
Newcastle University
Enrollment
30
Start date
2026-05-04
Completion date
2027-01-22
Last update
2026-08-17

Conditions

Summary

Individuals who have had a cervical spinal cord injury which resulted in hand weakness

Detailed description

This study uses a randomised crossover design. Participants are allocated to one of two groups via randomisation (computer randomisation). Both groups receive the same intervention but in different orders across the 12-week study period. Group A receives the intervention device after visit 1. They use the device for at least 20 minutes daily for six weeks, returning it at visit 2. The six weeks following device return serve as the control period, with visit 3 occurring at week 12. Group B receives no intervention between visit 1 and visit 2 (control period). They receive the intervention device after visit 2, using it daily for six weeks before returning it at visit 3. Intervention: Participants perform a precisely timed hand movement in response to a visual cue presented via a mobile phone game. At the moment of movement, a brief electrical stimulus is delivered to a peripheral nerve via adhesive electrodes connected to a custom Bluetooth device. Participants complete approximately 300 paired stimulations per day throughout the six-week intervention period in their home environment. Total duration: 12 weeks per participant, comprising one six-week intervention period and one six-week control period. Participants attend three laboratory visits at weeks 0, 6 and 12.

Interventions

Inclusion criteria

1. >1 year post injury 2. Have a cervical spinal cord injury (C2-C7) resulting in hand weakness 3. Able to make a well-timed hand movement

Exclusion criteria

1. Uncontrolled medical problems including pulmonary, cardiovascular or orthopaedic disease 2. Psychosis or altered cognitive status which would affect consent 3. History of head injury or stroke 4. Fitted with cardiac pacemaker (a contraindication for TMS) 5. Metal plate in skull (a contraindication for TMS) 6. History of seizures (a contraindication for TMS) 7. Pregnant females 8. Ongoing cord compression or a syrinx in the spinal cord or spinal cord disease such as spinal stenosis, spina bifida or herniated cervical disk 9. An aversion to loud sounds

Locations

Related clinical trials

View on source registry