Spinal Stimulation for Chronic Complete Tetraplegia (Complete TESCS)

August 29, 2022 updated by: NHS Greater Glasgow and Clyde

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
26 weeks at the end of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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
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)
26 weeks at the end of intervention
Spasticity
Time Frame: 26 weeks at the end of intervention
Changes in upper limb muscle tone using change in the Modified Ashworth Scale.
26 weeks at the end of intervention
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.
26 weeks at the end of intervention
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.
26 weeks at the end of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NHS Greater Glasgow and Clyde

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
International Spinal Research Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mariel Purcell, Consultant, NHS Greater Glasgow and Clyde

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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