Spinal Stimulation for Chronic Complete Tetraplegia

NCT05522920 | Unknown DMC

• 1 other identifier: GN20NE064
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is investigate the acceptability and effectiveness of transcutaneous spinal cord stimulation in people with complete high level spinal cord injury.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• Acceptance

  Whether the treatment protocol is acceptable by people with complete tetraplegia. This will be assessed using semi structured interview results of which will be analysed qualitatively to determine the number of participants who would use the therapy on an ongoing basis.

  26 weeks at the end of intervention

Secondary Outcomes (6)

• Clinical effectiveness of spinal cord stimulation using GRASSP tool

  26 and 38 weeks, at the end of intervention and at follow up respectively

• Neurophysiological change

  26 and 38 weeks, at the end of intervention and at follow up respectively

• Sensation

  26 weeks at the end of intervention

• Spasticity

  26 weeks at the end of intervention

• Autonomic function

  26 weeks at the end of intervention

Study Arms (1)

Therapy

EXPERIMENTAL

Conventional physical therapy will be used with and without spinal cord stimulation to investigate improvement of upper limb function.

Other: Therapy with and without spinal cord stimulation

Interventions

Therapy with and without spinal cord stimulation OTHER

Conventional therapy only will be followed with conventional therapy combined with electrical spinal cord stimulation.

Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give informed consent for participation in the study
• 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

You may not qualify if:

• Any implanted active metallic device including, but not limited to neurostimulators, cochlear implants, pacemakers, implantable defibrillators, or drug delivery pumps
• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• International Spinal Research Trust: collaborator

Related Publications (1)

• 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.

  PMID: 40583777 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Therapeutics; Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation

Study Officials

• Mariel Purcell, Consultant

  NHS Greater Glasgow and Clyde

  STUDY DIRECTOR

Central Study Contacts

Mariel Purcell, Consultant

CONTACT

+44 141 201 2536; margaret.purcell@ggc.scot.nhs.uk

Bethel C Osuagwu, PhD

CONTACT

+44 7944142407; bethel.osuagwu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive study intervention

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 31, 2022
• Study Start: August 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 31, 2022

Record last verified: 2022-08