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Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement

Sponsored by University College, London

About this trial

Last updated 2 years ago

Study ID

319893

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 months ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status

Recruiting