Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement
Up-Stim
1 other identifier
interventional
18
1 country
1
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. The aim of this feasibility study is to assess and compare the impact of adding TSCS to the standard rehabilitation of inpatients with acute SCI, compared to a sham (placebo) TSCS intervention added to standard rehabilitation, in an effort to enhance upper limb control and function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 28, 2023
CompletedFirst Submitted
Initial submission to the registry
August 7, 2023
CompletedFirst Posted
Study publicly available on registry
August 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 16, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 16, 2028
December 10, 2025
December 1, 2025
4.8 years
August 7, 2023
December 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in International Standards of Neurological Classification for SCI (ISNC-SCI).
This is a is a clinician-administered scale used to classify the severity (completeness) of injury in individuals with SCI.
30 minutes
Secondary Outcomes (8)
Modified Ashworth Scale (MAS)
20 minutes
Range of Motion (ROM)
20 minutes
Electromyography (EMG) assessments
90 minutes
Individual goal planning
20 minutes
Spinal Cord Independence Measure (SCIM)
30 minutes
- +3 more secondary outcomes
Study Arms (2)
Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation
ACTIVE COMPARATORStandard inpatient rehabilitation received at the Royal National Orthopaedic Hospital NHS Trust
Transcutaneous spinal cord stimulation added to inpatient rehabilitation
EXPERIMENTALTranscutaneous spinal cord stimulation added to standard inpatient rehabilitation, targetting the upper limbs, received at the Royal National Orthopaedic Hospital NHS Trust
Interventions
Sham transcutaneous spinal cord stimulation (placebo) added to Standard inpatient rehabilitation given at the Royal National Orthopaedic Hospital NHS Trust
Non-invasive electrical stimulation delivered over the spine, targetting movement of the upper limbs
Eligibility Criteria
You may qualify if:
- Over the age of 18
- Recent spinal cord injury (inpatient at the RNOH)
- Spinal cord injury level C1-C8
- AIS A-D
- Willing and able to provide informed consent
You may not qualify if:
- Women who are pregnant, planning pregnancy or breastfeeding
- Those who have a cardiac pacemaker
- Active device at stimulating electrode site
- Any other musculoskeletal diagnosis affecting the upper limbs
- Spinal malignancy
- Spinal cord injury due to cancerous growth
- Auto-immune disorder
- Ongoing infection
- Uncontrolled autonomic dysreflexia
- Complex regional pain syndrome
- Neurological degenerative diseases
- Peripheral nerve damage affecting the upper limbs
- Taking part in a conflicting research study
- People who are unable to tolerate TSCS during their first session
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal National Orthopaedic Hospital
London, HA7 4LP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lynsey Duffell, PhD
University College, London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2023
First Posted
August 15, 2023
Study Start
June 28, 2023
Primary Completion (Estimated)
April 16, 2028
Study Completion (Estimated)
April 16, 2028
Last Updated
December 10, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share
As the study is only 6 participants IPD will be provided in study publications.