Clinical trial NCT05991804: Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement
Official title: Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Rehabilitation
Transcutaneous spinal cord stimulation
Upper limb
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Royal National Orthopaedic Hospital NHS Trust
First posted: 2023-08-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot study
Primary purpose: TREATMENT

Brief summary: In the United Kingdom, there are more than 1000 new cases of spinal cord injury (SCI) each year, with around half of these injuries affecting the cervical spine. People who have reduced function and control affecting their upper limbs may have difficulty carrying out activities of daily living (ADLs), significantly affecting their independence. Recovering even partial upper limb function is a top priority among tetraplegics.

Regaining voluntary function in the upper limb can have a huge impact on quality of life. Using TSCS in the upper limb for acute SCI can benefit patients early in their rehabilitation, and may reduce the number of patients with problematic spasticity at discharge. Transcutaneous spinal cord stimulation (TSCS) may provide a low-cost method of improving function and spasticity in this cohort.

We are investigating the effect of adding non-invasive SCS to inpatient rehabilitation on upper limb function for people with acute SCI. We will test this by randomly assigning volunteers to either a control group, who will receive their normal inpatient rehabilitation only, and an intervention group, who will have non-invasive SCS added to their normal inpatient rehabilitation, targeting their upper limbs.

Detailed description: Recruitment:

Participants will be recruited from the Royal National Orthopaedic Hospital. A member of our research team will contact participants after they have received this information sheet to discuss participation in the study and answer any questions. People who would like to take part in the study will be asked to attend an initial session to see if they are able to tolerate non-invasive SCS.

Intervention:

Eligible participants will then be randomised into either the control group, where they will receive their standard inpatient rehabilitation only, or into the intervention group, where they will have non-invasive SCS added to their inpatient rehabilitation, targeting the arms and hands.

For both the control and intervention groups, we will carry out regular assessments. Some of these assessments will be part of standard care as an inpatient at the RNOH, and others will be additional. Please see the outcome measures for further information about these assessments.

Follow-up:

When participants have finished their inpatient rehabilitation at the RNOH, we will carry out a semi-structured interview, where we will ask about participants' experience on this study. Interviews may take place in person, over the phone, or over video call (e.g. Microsoft Teams or Zoom).

After participants have been discharged from the RNOH, we will contact you to do some follow-up assessments, which can be done at home or over the phone. There will be 2 follow-up assessments, the first will be done at 6-months post-injury, and the second will be done at 1-year post-injury. If participants are already 6-months post-injury at discharge, then the first follow-up assessment will be done at 1-month post-discharge, and the second at 1-year post-injury. The follow-up assessments will be the TUAQ, and the SCI-QoL.

Eligibility criteria: Inclusion Criteria:

1. Over the age of 18
2. Recent spinal cord injury (inpatient at the RNOH)
3. Spinal cord injury level C1-C8
4. AIS A-D
5. Willing and able to provide informed consent

Exclusion Criteria:

1. Women who are pregnant, planning pregnancy or breastfeeding
2. Those who have a cardiac pacemaker
3. Active device at stimulating electrode site
4. Any other musculoskeletal diagnosis affecting the upper limbs
5. Spinal malignancy
6. Spinal cord injury due to cancerous growth
7. Auto-immune disorder
8. Ongoing infection
9. Uncontrolled autonomic dysreflexia
10. Complex regional pain syndrome
11. Neurological degenerative diseases
12. Peripheral nerve damage affecting the upper limbs
13. Taking part in a conflicting research study
14. People who are unable to tolerate TSCS during their first session

Primary outcomes:
measure: Change in International Standards of Neurological Classification for SCI (ISNC-SCI).
timeFrame: 30 minutes
Secondary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: 20 minutes
measure: Range of Motion (ROM)
timeFrame: 20 minutes
measure: Electromyography (EMG) assessments
timeFrame: 90 minutes
measure: Individual goal planning
timeFrame: 20 minutes
measure: Spinal Cord Independence Measure (SCIM)
timeFrame: 30 minutes
measure: Tetraplegic upper limb activity questionnaire (TUAQ)
timeFrame: 30 minutes
measure: International SCI data sets quality of life basic data set (SCI-QoL)
timeFrame: 15 minutes
measure: Semi-structured interview
timeFrame: 60 minutes
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal National Orthopaedic Hospital
Study officials:
affiliation: University College, London
name: Lynsey Duffell, PhD
role: PRINCIPAL_INVESTIGATOR
References: