search
Back to results

Spinal Stimulation for Chronic Complete Tetraplegia (Complete TESCS)

Primary Purpose

Spinal Cord Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therapy with and without spinal cord stimulation
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Therapy

    Arm Description

    Conventional physical therapy will be used with and without spinal cord stimulation to investigate improvement of upper limb function.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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)
    Spasticity
    Changes in upper limb muscle tone using change in the Modified Ashworth Scale.
    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.
    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.

    Full Information

    First Posted
    August 25, 2022
    Last Updated
    August 29, 2022
    Sponsor
    NHS Greater Glasgow and Clyde
    Collaborators
    International Spinal Research Trust
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05522920
    Brief Title
    Spinal Stimulation for Chronic Complete Tetraplegia
    Acronym
    Complete TESCS
    Official Title
    Non-invasive Spinal Cord Stimulation Combined With Activity-based Therapy in Chronic Complete High Level Spinal Cord Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2022 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NHS Greater Glasgow and Clyde
    Collaborators
    International Spinal Research Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injuries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    All participants will receive study intervention
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Therapy
    Arm Type
    Experimental
    Arm Description
    Conventional physical therapy will be used with and without spinal cord stimulation to investigate improvement of upper limb function.
    Intervention Type
    Other
    Intervention Name(s)
    Therapy with and without spinal cord stimulation
    Intervention Description
    Conventional therapy only will be followed with conventional therapy combined with electrical spinal cord stimulation.
    Primary Outcome Measure Information:
    Title
    Acceptance
    Description
    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.
    Time Frame
    26 weeks at the end of intervention
    Secondary Outcome Measure Information:
    Title
    Clinical effectiveness of spinal cord stimulation using GRASSP tool
    Description
    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.
    Time Frame
    26 and 38 weeks, at the end of intervention and at follow up respectively
    Title
    Neurophysiological change
    Description
    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.
    Time Frame
    26 and 38 weeks, at the end of intervention and at follow up respectively
    Title
    Sensation
    Description
    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)
    Time Frame
    26 weeks at the end of intervention
    Title
    Spasticity
    Description
    Changes in upper limb muscle tone using change in the Modified Ashworth Scale.
    Time Frame
    26 weeks at the end of intervention
    Title
    Autonomic function
    Description
    Changes in autonomic function will be assessed using changes in the AUTONOMIC STANDARDS ASSESSMENT FORM of the International Spinal Cord Injury Data Set.
    Time Frame
    26 weeks at the end of intervention
    Title
    Change in perceived health status
    Description
    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.
    Time Frame
    26 weeks at the end of intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mariel Purcell, Consultant
    Phone
    +44 141 201 2536
    Email
    margaret.purcell@ggc.scot.nhs.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bethel C Osuagwu, PhD
    Phone
    +44 7944142407
    Email
    bethel.osuagwu@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mariel Purcell, Consultant
    Organizational Affiliation
    NHS Greater Glasgow and Clyde
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    The is no plan yet to share individual participant data.

    Learn more about this trial

    Spinal Stimulation for Chronic Complete Tetraplegia

    We'll reach out to this number within 24 hrs