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Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia (SCIMS Main)

Primary Purpose

Tetraplegia/Tetraparesis

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BES + TS

Experimental: BES+sham TS

About this trial

This is an interventional treatment trial for Tetraplegia/Tetraparesis focused on measuring Spinal Cord Injury

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A written clearance from the study medical doctor to ensure that the participant is safely able to engage in the study.
Participants must have a companion that will be able to help him/her throughout the study.
Greater than 1-year post SCI, neurologic level of C8 or above.
American Spinal Injury Association Impairment Scale (AIS) scores of B, C, or D indicating presence of an incomplete SCI.
Visible muscle contraction response to NMES wrist extensors, bilaterally.
Agreement to use telehealth services for delivery of research exercise training by study staff. Possesses appropriate technology to engage in telehealth including a personal web camera, computer, microphone, speakers, and high-speed broadband internet connection, valid email address (needed to obtain VA issued video conferencing software), and telephone number used to obtain login credentials for the In-Home Video Software - Cisco Jabber Video for Telepresence Software.
Response of muscle contraction of wrist extensors bilaterally to neuromuscular electrical stimulation.

Exclusion Criteria:

Unhealed fracture in upper or lower extremities.
Severe scoliosis, severe upper extremity contractures, or other musculoskeletal issues that would impede participation in a BES + TS intervention or valid evaluation of outcome measures.
High resting blood pressure greater than 140/80 mmHg.
Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons.
Pregnancy (female participants). A home pregnancy test will be conducted to role out any pregnancy before the study at the McGuire VAMC. The test will be repeated every month during the course of the study.
Implanted pacemakers and/or implanted defibrillator devices.
Other exclusion criteria may include the presence of implanted electrical device, cancer, thrombosis, pacemaker, defibrillator, or seizures. Patients who are currently on or receive anti-platelet or anticoagulant medications will be excluded from the trial.
Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study.
Other exclusion criteria at the discretion of the medical team may include:
1. Uncontrolled autonomic dysreflexia (AD), refers to episodes of AD that do not respond to medications to ensure stable blood pressure in persons with SCI
2. Concurrent severe neurological injuries other than SCI: MS, CP, severe TBI, and stroke.
3. Unresolved deep vein thrombosis.
4. Psychiatric or cognitive impairments that preclude adherence to the intervention.
5. Known cardiac pathology that precludes safe participation.
6. Metabolic conditions such as cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin.
7. Presence of pressure sores stage three or greater.
8. Presence of a symptomatic urinary tract infection.
9. Severe spasticity as assessed by the Modified Ashworth Scale.
10. Changing neurologic status due to conditions such as progressive posttraumatic syringomyelia.

Sites / Locations

Sheltering Arms Physical Rehabilitation CentersRecruiting
Richmond VA Medical CenterRecruiting
Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

BES+TS

BES+sham TS

Arm Description

Blood Flow Restriction Enhanced Neuromuscular Electrical Stimulation (BES) treatment plus transspinal stimulation (TS) plus repetitive practice of task-specific activities, also known as massed practice (MP)

Blood Flow Restriction Enhanced Neuromuscular Electrical Stimulation (BES) sham treatment plus transspinal stimulation (TS) plus repetitive practice of task-specific activities, also known as massed practice (MP)

Outcomes

Primary Outcome Measures

Change in hand functional activities

The grasp and release test is a standardized test of functional activities depending on hand function in persons with cSCI. Participants will be asked to lift and move a peg, block, can, 1 lb. dumbbell weight and fork from lateral to medial over a 60 cm distance and release at midline.

Change in maximum grip strength without TS

Using a standard hand-grip dynamometer, participants will be asked to squeeze the dynamometer with one hand at a time as strongly as possible for up to 3 seconds, to obtain a measure of the maximal voluntary force they can generate when closing their hand

Change in maximum grip strength with TS

Change in electrical activity activation with TS

During the assessment of maximal grip strength with TS, electromyography (EMG) will be used to measure the amount of neuromuscular electrical activation from the following muscle groups: wrist flexors, wrist extensors, elbow flexors, and elbow extensors.

Change in EMG activation without TS

During the assessment of maximal grip strength without TS, electromyography (EMG) will be used to measure the amount of neuromuscular electrical activation: wrist flexors, wrist extensors, elbow flexors, and elbow extensors.

Change in tactile perception

The Semmes-Weinstein Monofilament Exam is used to assess cutaneous tactile perception in individuals with spinal cord injury to provide more precise assessment of sensory function. Semmes-Weinstein Monofilaments are small, thin fibers attached to a handle that bend once a certain amount of force (ranging from 0.07 - 300 grams) is applied. With eyes closed, participants will be asked whether they can feel a light touch from the monofilaments at standard locations on the palm and dorsum of the hand and fingers. Participants are given a score depending on what the thinnest filament and thus, what the smallest amount of force is which needs to be applied for them to perceive a tactile stimulus.

Secondary Outcome Measures

Changes in capacity to perform functional activities

Functional activity will be measured using the Spinal Cord Injury-Functional Index Short Form (SCI-FI SF). The SCI-FI SF is a comprehensive measure of functional activity capacity for persons with SCI. It measures three subscales: Basic Mobility (9 items), Self-Care (9 items), and Fine Motor Function (8 items). Participants respond to item prompts using a Likert-type scale with anchors from 1 = "With much difficulty" to 4 = "Without any difficulty." Item scores for each subscale are summed and then converted to standardized T-scores, with higher scores reflecting greater functional capacity. We will use the tetraplegia-specific versions of the Self-Care and Fine Motor Function subscales.

Change in vital capacity

Forced vital capacity is an evaluation of how much air a person can forcefully exhale after a maximal inspiratory effort. Tests are conducted using a digital spirometer or respiratory monitor. Participants will be asked to seal their lips around a disposable mouthpiece connected to the respiratory monitor via an anti-viral/anti-bacterial filter, then take a maximal inhalation immediately followed by a forceful exhalation which participants will be encouraged to maintain for as long as possible.

Change in ventilatory muscle strength

Maximal inspiratory pressure and maximal expiratory pressure using a digital respiratory pressure meter are measures of ventilatory muscle strength. Participants will be asked to exhale fully, then seal their lips around a disposable mouthpiece and inhale as strongly as possible against an occlusion. They will be asked to inhale maximally and then exhale through a disposable mouthpiece against an occlusion.

Change in heart rate variability

Tilt table test for heart rate variability will be used to assess changes in heart rate variability.

Full Information

NCT ID

NCT05423600

First Posted

June 8, 2022

Last Updated

June 23, 2023

Sponsor

Virginia Commonwealth University

Collaborators

National Institute on Disability, Independent Living, and Rehabilitation Research, Administration for Community Living

1. Study Identification

Unique Protocol Identification Number

NCT05423600

Brief Title

Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia

Acronym

SCIMS Main

Official Title

Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 15, 2022 (Actual)

Primary Completion Date

September 2026 (Anticipated)

Study Completion Date

September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Virginia Commonwealth University

Collaborators

National Institute on Disability, Independent Living, and Rehabilitation Research, Administration for Community Living

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the current study is to evaluate whether a home-based, telehealth-supported intervention combining Blood Flow Restricted Exercise (BES) and Transspinal Stimulation (TS) will improve motor and functional abilities greater than BES+sham TS in persons with chronic, incomplete tetraplegia.

Detailed Description

Cervical spinal cord injury (cSCI) results in physical impairment and limited mobility, with the most severe cSCI necessitating wheelchair use for ambulation and impaired upper extremity function resulting in subsequent chronic comorbidities. These comorbidities may include psychosocial, cardiovascular, metabolic and respiratory consequences, as well as a significant socioeconomic burden. The economic burdens for persons with cSCI, their families, and society are increasing at an alarming rate, especially with decreasing mortality due to advances in medical interventions. Restoring some degree of upper extremity and hand function would improve overall functional ability and quality of life. Through physical rehabilitation, upper extremity function can improve, but gains are limited for people with the most severe, motor-complete cSCI. Attempts have been made to restore and improve upper extremity and hand function using implanted epidural stimulation of the cervical spinal cord, but alternatives to this invasive therapy are warranted to maximize the amount of people who may benefit from enhanced motor activation. The total study duration is 30 weeks. The first 4 weeks will start and end with baseline assessments (Baseline 1 &2). The rest of this 4-week period will consist of 2 sessions/week of education and optimization provided to the participant and a caregiver, to instruct them to use the TS device and blood pressure machine and carry out massed practice training for both groups. The first two weeks of this 4-week phase will occur onsite in the laboratory, and the second two weeks of this 4-week phase will occur at home via telehealth to familiarize participants and companions with the telehealth platform - however, if the participant and companion desire more on-site instruction, they may come into the lab to do this during this time as well. Following the first 4-week phase, 16 weeks of 3 sessions/week of BES+TS or BES+sham TS training at home with supervision from the research team via telehealth will occur. In the week following completion of the intervention, post-intervention outcome measures assessments will take place. There will then be an 8-week washout period where participants will receive no training. Following the 8-week washout, participants will be asked to come back to the lab for one more follow-up assessment of outcome measures to test any long-term effects of the intervention.

6. Conditions and Keywords

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

Tetraplegia/Tetraparesis

Keywords

Spinal Cord Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BES+TS

Arm Type

Experimental

Arm Description

Arm Title

BES+sham TS

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

BES + TS

Intervention Description

Intervention Type

Procedure

Intervention Name(s)

Experimental: BES+sham TS

Intervention Description

Primary Outcome Measure Information:

Title

Change in hand functional activities

Description

Time Frame

Baseline to 20 weeks

Title

Change in maximum grip strength without TS

Description

Time Frame

Baseline to 20 weeks

Title

Change in maximum grip strength with TS

Description

Time Frame

Baseline to 20 weeks

Title

Change in electrical activity activation with TS

Description

Time Frame

Baseline to 20 weeks

Title

Change in EMG activation without TS

Description

Time Frame

Baseline to 20 weeks

Title

Change in tactile perception

Description

Time Frame

Baseline to 20 weeks

Secondary Outcome Measure Information:

Title

Changes in capacity to perform functional activities

Description

Time Frame

Baseline to 20 weeks

Title

Change in vital capacity

Description

Time Frame

Baseline to 20 weeks

Title

Change in ventilatory muscle strength

Description

Time Frame

Baseline to 20 weeks

Title

Change in heart rate variability

Description

Tilt table test for heart rate variability will be used to assess changes in heart rate variability.

Time Frame

Baseline to 20 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A written clearance from the study medical doctor to ensure that the participant is safely able to engage in the study. Participants must have a companion that will be able to help him/her throughout the study. Greater than 1-year post SCI, neurologic level of C8 or above. American Spinal Injury Association Impairment Scale (AIS) scores of B, C, or D indicating presence of an incomplete SCI. Visible muscle contraction response to NMES wrist extensors, bilaterally. Agreement to use telehealth services for delivery of research exercise training by study staff. Possesses appropriate technology to engage in telehealth including a personal web camera, computer, microphone, speakers, and high-speed broadband internet connection, valid email address (needed to obtain VA issued video conferencing software), and telephone number used to obtain login credentials for the In-Home Video Software - Cisco Jabber Video for Telepresence Software. Response of muscle contraction of wrist extensors bilaterally to neuromuscular electrical stimulation. Exclusion Criteria: Unhealed fracture in upper or lower extremities. Severe scoliosis, severe upper extremity contractures, or other musculoskeletal issues that would impede participation in a BES + TS intervention or valid evaluation of outcome measures. High resting blood pressure greater than 140/80 mmHg. Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons. Pregnancy (female participants). A home pregnancy test will be conducted to role out any pregnancy before the study at the McGuire VAMC. The test will be repeated every month during the course of the study. Implanted pacemakers and/or implanted defibrillator devices. Other exclusion criteria may include the presence of implanted electrical device, cancer, thrombosis, pacemaker, defibrillator, or seizures. Patients who are currently on or receive anti-platelet or anticoagulant medications will be excluded from the trial. Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study. Other exclusion criteria at the discretion of the medical team may include: Uncontrolled autonomic dysreflexia (AD), refers to episodes of AD that do not respond to medications to ensure stable blood pressure in persons with SCI Concurrent severe neurological injuries other than SCI: MS, CP, severe TBI, and stroke. Unresolved deep vein thrombosis. Psychiatric or cognitive impairments that preclude adherence to the intervention. Known cardiac pathology that precludes safe participation. Metabolic conditions such as cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin. Presence of pressure sores stage three or greater. Presence of a symptomatic urinary tract infection. Severe spasticity as assessed by the Modified Ashworth Scale. Changing neurologic status due to conditions such as progressive posttraumatic syringomyelia.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ashraf Gorgey, MPT, PhD, FACSM, FACRM

Phone

804-675-5000

Ext

3386

Ashraf.Gorgey@va.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Refka Khalil

Phone

804-675-5000

Ext

6249

Refka.Khalil@va.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ashraf Gorgey, MPT, PhD, FACSM, FACRM

Organizational Affiliation

Virginia Commonwealth University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sheltering Arms Physical Rehabilitation Centers

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23226

Country

United States

Individual Site Status

Recruiting

Facility Name

Richmond VA Medical Center

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23249

Country

United States

Individual Site Status

Recruiting

Facility Name

Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

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Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia

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