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Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia

Primary Purpose

Spinal Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TESS
Training
Motor Task
sham-TESS
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal Cord Injury, Motor Function, Reaching, Grasping, Hand Movement

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Inclusion criteria for SCI:

  • Male and female Veterans between 18-70 years
  • Chronic SCI (1 year of injury)

  • Cervical injury at C8 or above - damage between cervical spinal segments will be confirmed using MRI [preliminary data (Benavides et al., 2020) and analysis of MRIs in ~100 participants with cervical SCI confirm that the investigators can meet our recruitment goals. Note that most SCI in humans damage several spinal cord segments

    • Verification of damage to cervical spinal segments will ensure that TESS electrodes will target the injured spinal cord (Benavides et al., 2020)
  • Intact or impaired, but not absent, innervations in dermatomes C6, C7 and C8 during light touch and pin prick stimulus using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) sensory scores as tested before in our studies (Bunday and Perez, 2012; Bunday et al., 2018; Benavides et al., 2020; Jo and Perez, 2020)
  • Able to produce a visible power grip with one hand

  • Can score a minimum of two (2) in the cylindrical grasp the "Prehension Ability" GRASSP

    • This criterion was selected to ensure that hand impairment will not interfere with the ability to perform training and the proposed tests

Inclusion criteria for controls:

  • Males and females (18-70 years)
  • Right-handed
  • Able to complete grasping

Exclusion Criteria:

Exclusion criteria for SCI and control subjects:

  • Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
  • Any debilitating disease prior to the SCI that caused exercise intolerance
  • Premorbid, ongoing major depression or psychosis, altered cognitive status
  • History of head injury or stroke
  • Pacemaker
  • Metal plate in skull
  • History of seizures
  • Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold, such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants
  • Pregnant females
  • Ongoing cord compression, or a syrinx in the spinal cord, or one who suffers from a spinal cord disease such as spinal stenosis, spina bifida, or herniated cervical disk

Sites / Locations

  • Shirley Ryan AbilityLabRecruiting
  • Edward Hines Jr. VA Hospital, Hines, ILRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Arm Label

Active TESS Group 1

Sham TESS Group 1

Active TESS + Training

Arm Description

Subjects with SCI and without SCI (controls) will participate in two testing sessions, separated by 2-3 days, using a crossover design. In each session, active transcutaneous electrical spinal stimulation (TESS) will be applied over the cervical spinal cord. Functional and physiological measures will be acquired before and after each session.

Subjects with SCI and without SCI (controls) will participate in two testing sessions, separated by 2-3 days, using a crossover design. In each session, sham transcutaneous electrical spinal stimulation (sham-TESS) will be applied over the cervical spinal cord. Functional and physiological measures will be acquired before and after each session.

Develop methodologies to promote recovery of reaching and grasping movements. To accomplish this goal, the investigators will combine TESS applied in a closed-loop manner with massed practice upper-limb training. Participants will be assigned to one of three groups in a randomized order for a controlled design: [1) Closed-loop TESS applied during grasping + training, 2) Closed-loop TESS applied during reaching + training, and 3) Closed-loop TESS applied during grasping & reaching + training.] TESS for 20-min will be followed by 60 min of massed practice exercise training (total=20 sessions).

Outcomes

Primary Outcome Measures

Changes in amplitude of Motor evoked potential size
Ten stimuli (0.2 Hz) will be delivered at each intensity to plot the mean peak-to-peak amplitude of the MEP from the non-rectified response against the TMS intensity in each subject (MEP recruitment curve).
Change in GRASSP Test
The GRASSP will be used to asses several domains of arm/hand function in humans with cervical SCI, specifically assessing three domains of hand function: 1) strength, 2) sensibility, and 3) prehension. The time to administer the test is ~45 min. The GRASSP has 5 subsets: Dorsal sensation: (3 locations, each scored 0-4, sum=0-12) Palmar sensation: (3 locations, each scored 0-4, sum=0-12) Strength: (10 muscles of arm and hand, motor score 0-5, sum=0-50) Prehension ability: (3 grasps (cylindrical, lateral key, tip to tip), each scored 0-4, sum=0-12) Prehension performance: There are 6 prehension tasks. Pouring water from a bottle, opening jars, picking up and turning a key, transferring 9 pegs from board to board, picking up four coins and place in slots, screwing four nuts onto bolts. Each task is scored 0-5, sum=0-30.
Changes in amplitude of cervicomedullary motor evoked potential size
Ten Transcranial magnetic stimuli (TMS) will be delivered to plot the mean peak-to-peak amplitude of the motor and cervicomedullary evoked potentials (MEPs and CMEPs, respectively) from the non-rectified response against the TMS intensity in each subject (MEP/CMEP recruitment curves).

Secondary Outcome Measures

Full Information

First Posted
November 24, 2021
Last Updated
January 26, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05157282
Brief Title
Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia
Official Title
Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In support of the long-term goal of developing new strategies to increase limb function after SCI, the objectives of this proposal are to: 1) Examine the behavioral and physiological effects of TESS on upper-limb muscles after cervical SCI; and 2) Maximize the recovery of reaching and grasping potential by using tailored TESS in a task-specific manner with motor training. Veterans with cervical spinal injuries and healthy volunteers will be recruited for this study.
Detailed Description
Current studies demonstrate that electrical spinal stimulation, either invasive or noninvasive, can play an important role in rehabilitation strategies aimed at improving limb function in humans with SCI (Taccola et al., 2018). Among current stimulation strategies, one of the most promising candidates to emerge in recent years is transcutaneous electrical spinal stimulation (TESS). TESS is a noninvasive technique that can be tailored to the needs of each individual, where several segments of the spinal cord can be stimulated at the same time, and delivery can be programed to interact with a rehabilitation strategy during functional movements, such as reaching or grasping. A key element to TESS is its ability to access spared spinal cord networks with minimal discomfort. Although promising, the knowledge of TESS remains limited in scope and more studies are needed to further identify its efficacy. In Aim 1, subjects will participate in two randomized sessions: 1) TESS, and 2) sham-TESS.] In Aim 2, the investigators will examine the effect of stimulation and training for a total of 20 sessions (3 to 5 per week). Participants will be randomly assigned to: [1) Closed-loop TESS applied during grasping + training, or 2) Closed-loop TESS applied during reaching + training.] AIM 1 Subjects with SCI and without SCI (controls) will participate in two testing sessions, separated by 2-3 days, using a crossover design. In each session, TESS or sham-TESS will be applied over the cervical spinal cord. Functional and physiological measures will be acquired before and after each session. AIM 2 Develop methodologies to promote recovery of reaching and grasping movements. To accomplish this goal, the investigators will combine TESS applied in a closed-loop manner with massed practice upper-limb training. Participants will be assigned to one of three groups in a randomized order using a sham controlled design: [1) Closed-loop TESS applied during grasping + training, 2) Closed-loop TESS applied during reaching + training, and 3) Closed-loop TESS applied during grasping & reaching + training.] TESS for 20-min will be followed by 60 min of massed practice exercise training (total=20 sessions).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Spinal Cord Injury, Motor Function, Reaching, Grasping, Hand Movement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Transcutaneous electrical spinal stimulation (TESS)
Masking
Participant
Masking Description
Participants will not know if they receive real or sham stimulation
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active TESS Group 1
Arm Type
Active Comparator
Arm Description
Subjects with SCI and without SCI (controls) will participate in two testing sessions, separated by 2-3 days, using a crossover design. In each session, active transcutaneous electrical spinal stimulation (TESS) will be applied over the cervical spinal cord. Functional and physiological measures will be acquired before and after each session.
Arm Title
Sham TESS Group 1
Arm Type
Sham Comparator
Arm Description
Subjects with SCI and without SCI (controls) will participate in two testing sessions, separated by 2-3 days, using a crossover design. In each session, sham transcutaneous electrical spinal stimulation (sham-TESS) will be applied over the cervical spinal cord. Functional and physiological measures will be acquired before and after each session.
Arm Title
Active TESS + Training
Arm Type
Active Comparator
Arm Description
Develop methodologies to promote recovery of reaching and grasping movements. To accomplish this goal, the investigators will combine TESS applied in a closed-loop manner with massed practice upper-limb training. Participants will be assigned to one of three groups in a randomized order for a controlled design: [1) Closed-loop TESS applied during grasping + training, 2) Closed-loop TESS applied during reaching + training, and 3) Closed-loop TESS applied during grasping & reaching + training.] TESS for 20-min will be followed by 60 min of massed practice exercise training (total=20 sessions).
Intervention Type
Device
Intervention Name(s)
TESS
Other Intervention Name(s)
NeoStim-5
Intervention Description
Small stimulation pulses will be given to the spine at C5-6 in a non invasive manner.
Intervention Type
Other
Intervention Name(s)
Training
Other Intervention Name(s)
Massed Practice Training
Intervention Description
The participant will be instructed to do repetitive motor movements with their arm or hand.
Intervention Type
Other
Intervention Name(s)
Motor Task
Intervention Description
Participants will be asked to perform specific motor tasks or movements with their fingers, hands, and arms.
Intervention Type
Device
Intervention Name(s)
sham-TESS
Other Intervention Name(s)
NeoStim-5
Intervention Description
Small sham stimulation pulses will be given to the spine at C5-6 in a non invasive manner.
Primary Outcome Measure Information:
Title
Changes in amplitude of Motor evoked potential size
Description
Ten stimuli (0.2 Hz) will be delivered at each intensity to plot the mean peak-to-peak amplitude of the MEP from the non-rectified response against the TMS intensity in each subject (MEP recruitment curve).
Time Frame
Change from baseline at study completion, average of 5 weeks
Title
Change in GRASSP Test
Description
The GRASSP will be used to asses several domains of arm/hand function in humans with cervical SCI, specifically assessing three domains of hand function: 1) strength, 2) sensibility, and 3) prehension. The time to administer the test is ~45 min. The GRASSP has 5 subsets: Dorsal sensation: (3 locations, each scored 0-4, sum=0-12) Palmar sensation: (3 locations, each scored 0-4, sum=0-12) Strength: (10 muscles of arm and hand, motor score 0-5, sum=0-50) Prehension ability: (3 grasps (cylindrical, lateral key, tip to tip), each scored 0-4, sum=0-12) Prehension performance: There are 6 prehension tasks. Pouring water from a bottle, opening jars, picking up and turning a key, transferring 9 pegs from board to board, picking up four coins and place in slots, screwing four nuts onto bolts. Each task is scored 0-5, sum=0-30.
Time Frame
Through study completion(average of 5 weeks) and during 6-month follow-up
Title
Changes in amplitude of cervicomedullary motor evoked potential size
Description
Ten Transcranial magnetic stimuli (TMS) will be delivered to plot the mean peak-to-peak amplitude of the motor and cervicomedullary evoked potentials (MEPs and CMEPs, respectively) from the non-rectified response against the TMS intensity in each subject (MEP/CMEP recruitment curves).
Time Frame
Change from baseline at study completion, average of 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for SCI: Male and female Veterans between 18-70 years Chronic SCI (1 year of injury) Cervical injury at C8 or above - damage between cervical spinal segments will be confirmed using MRI [preliminary data (Benavides et al., 2020) and analysis of MRIs in ~100 participants with cervical SCI confirm that the investigators can meet our recruitment goals. Note that most SCI in humans damage several spinal cord segments Verification of damage to cervical spinal segments will ensure that TESS electrodes will target the injured spinal cord (Benavides et al., 2020) Intact or impaired, but not absent, innervations in dermatomes C6, C7 and C8 during light touch and pin prick stimulus using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) sensory scores as tested before in our studies (Bunday and Perez, 2012; Bunday et al., 2018; Benavides et al., 2020; Jo and Perez, 2020) Able to produce a visible power grip with one hand Can score a minimum of two (2) in the cylindrical grasp the "Prehension Ability" GRASSP This criterion was selected to ensure that hand impairment will not interfere with the ability to perform training and the proposed tests Inclusion criteria for controls: Males and females (18-70 years) Right-handed Able to complete grasping Exclusion Criteria: Exclusion criteria for SCI and control subjects: Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease Any debilitating disease prior to the SCI that caused exercise intolerance Premorbid, ongoing major depression or psychosis, altered cognitive status History of head injury or concussion, skull fractures (or any skull deficit), unexplained headaches in the last 6 months, or stroke Pacemaker Metal plate in skull History of seizures Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold, such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants Pregnant females Ongoing cord compression, or a syrinx in the spinal cord, or one who suffers from a spinal cord disease such as spinal stenosis, spina bifida, or herniated cervical disk
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica A Perez, PhD
Phone
(312) 238-2886
Email
mperez04@sralab.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica A Perez, PhD
Organizational Affiliation
Edward Hines Jr. VA Hospital, Hines, IL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica A Perez, PhD
Phone
312-238-2886
Email
mperez04@sralab.org
Facility Name
Edward Hines Jr. VA Hospital, Hines, IL
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141-3030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan Morrow, OTR
Phone
248-721-0663
Email
Meghan.Morrow@va.gov
First Name & Middle Initial & Last Name & Degree
Monica A Perez, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia

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