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Spinal Stimulation for Chronic Complete Tetraplegia (Complete TESCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05522920
Recruitment Status : Not yet recruiting
First Posted : August 31, 2022
Last Update Posted : August 31, 2022
Sponsor:
Collaborator:
International Spinal Research Trust
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Therapy with and without spinal cord stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will receive study intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-invasive Spinal Cord Stimulation Combined With Activity-based Therapy in Chronic Complete High Level Spinal Cord Injury
Estimated Study Start Date : August 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. Neurophysiological change [ Time Frame: 26 and 38 weeks, at the end of intervention and at follow up respectively ]
    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.

  3. Sensation [ Time Frame: 26 weeks at the end of intervention ]
    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)

  4. Spasticity [ Time Frame: 26 weeks at the end of intervention ]
    Changes in upper limb muscle tone using change in the Modified Ashworth Scale.

  5. Autonomic function [ Time Frame: 26 weeks at the end of intervention ]
    Changes in autonomic function will be assessed using changes in the AUTONOMIC STANDARDS ASSESSMENT FORM of the International Spinal Cord Injury Data Set.

  6. Change in perceived health status [ Time Frame: 26 weeks at the end of intervention ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05522920


Contacts
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Contact: Mariel Purcell, Consultant +44 141 201 2536 margaret.purcell@ggc.scot.nhs.uk
Contact: Bethel C Osuagwu, PhD +44 7944142407 bethel.osuagwu@gmail.com

Sponsors and Collaborators
NHS Greater Glasgow and Clyde
International Spinal Research Trust
Investigators
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Study Director: Mariel Purcell, Consultant NHS Greater Glasgow and Clyde
More Information
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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT05522920    
Other Study ID Numbers: GN20NE064
First Posted: August 31, 2022    Key Record Dates
Last Update Posted: August 31, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The is no plan yet to share individual participant data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries