Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
12 participants
INTERVENTIONAL
2022-08-31
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Therapy
Conventional physical therapy will be used with and without spinal cord stimulation to investigate improvement of upper limb function.
Therapy with and without spinal cord stimulation
Conventional therapy only will be followed with conventional therapy combined with electrical spinal cord stimulation.
Interventions
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Therapy with and without spinal cord stimulation
Conventional therapy only will be followed with conventional therapy combined with electrical spinal cord stimulation.
Eligibility Criteria
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Inclusion Criteria
* Aged ≥18 years
* Injury level C3-C7, American Spinal Cord injury Association Impairment Scale (ASIA) A
* ≥1 year post-injury
* Medically stable, cognitively intact, and able to breathe independently
* Able to attend all sessions two or three times per week, for 2 h sessions and assessments
Exclusion Criteria
* Possible, suspected, or confirmed pregnancy and/or lactation
* Recent history or fracture, contractures or pressure sore, deep vein thrombosis (DVT) or urinary tract, or other infection that may interfere with the intervention and training
* History of epilepsy and/or seizures
* Severe spasticity which has been unstable over the 3 months prior to enrolment and is not expected to change and/or taking varying doses of anti-spasticity medications which could not be tapered to a stable dose and are not expected to change
* Botulinum toxin injections within 6 months of participation
* Non-injury related neurological impairment
* Clinically significant severe depression in spite of treatment
* Cardiovascular disease
* Autonomic dysreflexia that is severe, ongoing, and has required medical treatment within the past month
* Skin conditions or allergies that may affect electrode placement
* Do not understand English
* Received a stem cell treatment or other treatment that could possibly promote or attenuate neuroplastic changes in spinal or cortical function, within ≥2 years of enrolment; beyond this period, they may be included, provided the treatment was conducted in an accredited facility with proper ethics and regulatory approval.
* Involved in any other study involving stimulation of the spinal cord within 6 months of enrolment
* Information regarding recent rehabilitation or exercise programmes that participants may currently be engaged in will be discussed with clinical staff and fully documented for each participant
18 Years
ALL
No
Sponsors
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International Spinal Research Trust
OTHER
NHS Greater Glasgow and Clyde
OTHER
Responsible Party
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Principal Investigators
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Mariel Purcell, Consultant
Role: STUDY_DIRECTOR
NHS Greater Glasgow and Clyde
Central Contacts
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References
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McNicol EL, Osuagwu B, Purcell M, McCaughey EJ, Lincoln C, Cope L, Vuckovic A. Neurophysiological Effect of Transcutaneous Electrical Spinal Cord Stimulation in Chronic Complete Spinal Cord Injury. Artif Organs. 2025 Jun 30. doi: 10.1111/aor.15050. Online ahead of print.
Other Identifiers
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GN20NE064
Identifier Type: -
Identifier Source: org_study_id