Spinal Stimulation for Chronic Complete Tetraplegia (Complete TESCS)

Non-invasive Spinal Cord Stimulation Combined With Activity-based Therapy in Chronic Complete High Level Spinal Cord Injury

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Therapy with and without spinal cord stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariel Purcell, Consultant; Phone Number: +44 141 201 2536; Email: margaret.purcell@ggc.scot.nhs.uk
• Study Contact Backup: Name: Bethel C Osuagwu, PhD; Phone Number: +44 7944142407; Email: bethel.osuagwu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapy; 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; Conventional therapy only will be followed with conventional therapy combined with electrical spinal cord stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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
Neurophysiological change	Effectiveness of spinal cord stimulation in inducing changes in Neurophysiological equivalence of volitional movement. This will be assessed using changes in amplitude in mV of transcranial magnetic stimulation.	26 and 38 weeks, at the end of intervention and at follow up respectively
Sensation	Change in sensation due to the intervention. This will be assessed using change the sensory score of the International Standards for Neurological classification of SCI (ISNCSCI)	26 weeks at the end of intervention
Spasticity	Changes in upper limb muscle tone using change in the Modified Ashworth Scale.	26 weeks at the end of intervention
Autonomic function	Changes in autonomic function will be assessed using changes in the AUTONOMIC STANDARDS ASSESSMENT FORM of the International Spinal Cord Injury Data Set.	26 weeks at the end of intervention
Change in perceived health status	The effect of the study on perceived health status of the participants will be assessed using QUALITY OF LIFE BASIC DATA SET of the International Spinal Cord Injury Data Set.	26 weeks at the end of intervention

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: International Spinal Research Trust
• Investigators: Study Director: Mariel Purcell, Consultant, NHS Greater Glasgow and Clyde

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: GN20NE064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The is no plan yet to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No