Spinal Cord InjuriesComplete TESCSNCT05522920
Spinal Stimulation for Chronic Complete Tetraplegia
A study testing Therapy with and without spinal cord stimulation in people with Spinal Cord Injuries, run by NHS Greater Glasgow and Clyde.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Therapy with and without spinal cord stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Therapy with and without spinal cord stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy with and without spinal cord stimulationOther
Conventional therapy only will be followed with conventional therapy combined with electrical spinal cord stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Therapy | Experimental | Conventional physical therapy will be used with and without spinal cord stimulation to investigate improvement of upper limb function. Receives: Other: Therapy with and without spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26 weeks at the end of intervention
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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)
Measured: 26 weeks at the end of intervention
Spasticity
Changes in upper limb muscle tone using change in the Modified Ashworth Scale.
Measured: 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.
Measured: 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.
Measured: 26 weeks at the end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study startAug 2022 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive study intervention
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- International Spinal Research Trust
- Responsible party
- Sponsor
- Investigators
- Mariel Purcell, Consultant, Study director, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522920
- Sponsor's protocol ID
- GN20NE064
- Acronym
- Complete TESCS
- Status last verified
- Aug 2022
- First submitted
- 25 Aug 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The is no plan yet to share individual participant data.
Publications
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 Dec;49(12):1765-1786. doi: 10.1111/aor.15050. Epub 2025 Jun 30.
PubMed 40583777
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Spinal Cord Stimulation Combined With Activity-based Therapy in Chronic Complete High Level Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05522920
- Acronym / sponsor ID
- Complete TESCS / GN20NE064
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- International Spinal Research Trust
- Study start
- Aug 2022 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive study intervention
| Arm | Type | Receives |
|---|---|---|
| Therapy | Experimental | Other: Therapy with and without spinal cord stimulationConventional physical therapy will be used with and without spinal cord stimulation to investigate improvement of upper limb function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapy with and without spinal cord stimulationConventional therapy only will be followed with conventional therapy combined with electrical spinal cord stimulation. | Other | Therapy |
Primary outcome
Acceptance
Time frame: 26 weeks at the end of intervention
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.
6 secondary outcomes
Clinical effectiveness of spinal cord stimulation using GRASSP tool
Time frame: 26 and 38 weeks, at the end of intervention and at follow up respectively
Neurophysiological change
Time frame: 26 and 38 weeks, at the end of intervention and at follow up respectively
Sensation
Time frame: 26 weeks at the end of intervention
Spasticity
Time frame: 26 weeks at the end of intervention
Autonomic function
Time frame: 26 weeks at the end of intervention
Change in perceived health status
Time frame: 26 weeks at the end of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Derived from this study: PubMed 40583777McNicol 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 Dec;49(12):1765-1786. doi: 10.1111/aor.15050. Epub 2025 Jun 30.
- Individual participant dataSharing planned: Undecided. The is no plan yet to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariel Purcell, Consultant study director
NHS Greater Glasgow and Clyde
Questions about this trial
What is this clinical trial studying?
A study testing Therapy with and without spinal cord stimulation in people with Spinal Cord Injuries, run by NHS Greater Glasgow and Clyde.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariel Purcell, Consultant (+44 141 201 2536, margaret.purcell@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance (time frame: 26 weeks at the end of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05522920, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.