Chronic spinal cord injury Injury, Occupational Diseases, Poisoning Injury of spinal cord, level unspecified
Conditions
Interventions
Subjects fulfilling the selection criteria will be randomized (via computer generated code) to one of the two equal size parallel arms of the study.
Group A: Will first receive the wearable device (el
this produces a brief click with an intensity of 110 dB SPL. The earpiece is placed in the contralateral ear. An internal flash memory with plasticity stimulus protocol will be inserted under the cove
Sponsors
Newcastle University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chronic (>1 year) cervical injury (C2-C7) 2. Male or female at least 18 years of age 3. Detectable EMG activity in triceps 4. Without upper limb fracture or subluxation/ dislocation of joints within last six months. 5. Be able to follow study instructions and perform study tasks. 6. Willing to provide written informed consent; if necessary through an independent witness should the subject be unable to write themselves due to their injury.
Exclusion criteria
Exclusion criteria: 1. Exhibit major medical problems or poor physical conditions that would interfere with participation, as reported by the participant. 2. Excessive pain in any joint that might limit examination. 3. Participants with contraindications for TMS as confirmed by ‘TMS Adult Safety Screen’ questionnaire (Keel et al. 2001).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at baseline, after 4 and 8 weeks: 1. Electrophysiological changes in triceps muscle are measured using EMG 2. Motor evoked potential (MEP) size measured using transcranial magnetic brain stimulation 3. Maximal voluntary contraction measured using a force transducer and EMG 4. Reaction time measured using a StartReact paradigm 5. Reaching parameters such as speed and trajectory accuracy measured using a custom built planar reaching task 6. Upper extremity function measured using CUE questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Compliance (how long subjects use the device each day) using the device clock data and participants’ filled-up diary. 2. Adverse event profile among participants using our intervention device. 3. Range, speed and accuracy of upper limb movement (reaching task with Polhemus motion tracking system) before and after intervention 4. Maximum voluntary contraction force of elbow flexion and extension before and after intervention 5. Auditory startle response (StartReact paradigm) of triceps before and after intervention. This assay will examine the change of reticulospinal tract activity by the intervention (if any). 6. Auditory startle response (startle + TMS paradigm) of triceps before and after intervention. This assay will examine the change of reticulospinal tract activity by the intervention (if any). 7. Motor evoked potentials by transcranial magnetic stimulation (TMS with 2 different coil orientations) before and after intervention. This assay will examine the change of corticospinal tract activity by the intervention (if any). | — |
Countries
England, United Kingdom
Contacts
Public ContactMaria Germann
Outcome results
None listed