Spinal Stimulation for Chronic Complete Tetraplegia | NCT05522920

NCT05522920

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
International Spinal Research Trust	OTHER

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Therapy with and without spinal cord stimulation	Other	Conventional therapy only will be followed with conventional therapy combined with electrical spinal cord stimulation.	Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Clinical effectiveness of spinal cord stimulation using GRASSP tool	Effectiveness of spinal cord stimulation in inducing changes in functional outcome. This will be assessed using the Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP tool). The unit is based on the GRASSP measurement scale.	26 and 38 weeks, at the end of intervention and at follow up respectively

Eligibility Module

Eligibility Criteria

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

Name	Role	Phone	Extension	Email
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

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

ID	Term
D013812	Therapeutics
D062187	Spinal Cord Stimulation

ID	Term
D004599	Electric Stimulation Therapy
D026741	Physical Therapy Modalities
D012046	Rehabilitation