Spinal Stimulation for Chronic Complete Tetraplegia

NCT ID: NCT05522920

Last Updated: 2022-08-31

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will receive study intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Therapy with and without spinal cord stimulation

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Spinal Research Trust

OTHER

Sponsor Role collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mariel Purcell, Consultant

Role: STUDY_DIRECTOR

NHS Greater Glasgow and Clyde

Central Contacts

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Mariel Purcell, Consultant

Role: CONTACT

Phone: +44 141 201 2536

Email: [email protected]

Bethel C Osuagwu, PhD

Role: CONTACT

Phone: +44 7944142407

Email: [email protected]

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.

Reference Type DERIVED
PMID: 40583777 (View on PubMed)

Other Identifiers

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GN20NE064

Identifier Type: -

Identifier Source: org_study_id