Upper Extremity Training for Chronic Cervical Spinal Cord Injury
Primary Purpose
Spinal Cord Injuries
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
upper extremity stimulation
Sponsored by
About this trial
This is an interventional other trial for Spinal Cord Injuries
Eligibility Criteria
Inclusion Criteria:
- 18 years of age.
- spinal cord injury for greater than or equal to 6 months.
- spinal cord injury at a cervical neurologic level of injury.
Exclusion Criteria:
- ventilator dependent.
- history of fractures.
- pressure sore or skin issues.
- history of illicit drug abuse.
- history of cardiac, respiratory, bladder, renal or other medical disorder unrelated to spinal cord injury.
- bladder Botox injections less than 12 months prior.
- muscle Botox injections less than 12 months prior.
- colostomy bag or urostomy.
- implanted pump (i.e., baclofen pump, pain pump, etc).
- If I am female: I am pregnant at the time of enrollment or planning to become pregnant during the course of the study.
- unable to wean from anti-spasticity medication.
- contraindications to MRI imaging (pacemaker, metallic foreign body, aneurysm clip, etc.)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
transcutaneous stimulation
Arm Description
transcutaneous stimulation 60 sessions Transcutaneous stimulation 40sessions Transcutaneous stimulation 20 sessions
Outcomes
Primary Outcome Measures
Neuro Recovery Scale ( NRS).
Measure of the degree a person who has sustained a spinal cord injury (SCI) has recovered the ability to perform functional tasks relative to how the individual performed these tasks prior to injury. The NRS consists of a numeric version of the visual analog scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. This type of scale can be administered verbally.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04921592
Brief Title
Upper Extremity Training for Chronic Cervical Spinal Cord Injury
Official Title
Neuromodulation Training for Upper Extremity Recovery for Chronic Cervical Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 14, 2021 (Anticipated)
Primary Completion Date
June 15, 2022 (Anticipated)
Study Completion Date
November 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to understand how the combination of activity-based recovery training and targeted spinal cord transcutaneous stimulation (scTS) can improve participants' ability to use their hand, arms, and core.
Detailed Description
This study is to understand how the combination of activity-based recovery training and targeted spinal cord transcutaneous stimulation (scTS) can improve participants' ability to use their hand, arms, and core. Activity-based recovery training aims to advance independence without the use of assistive devices. Spinal cord transcutaneous stimulation is an electrical stimulation that is provided on top of the skin over specific areas of the spinal cord to activate the circuitry for the activity that is being trained and reconnect with pathways between the brain and spinal cord.
i) Physical evaluation by the clinician or physician including the Classification of Spinal Cord Injury (ISNCSCI exam. ii) A series of tests to evaluate the trunk, arm function with and without using tests to evaluate muscle activation. iii) A series of questionnaires to evaluate function and quality of life iv) Two separate Magnetic Resonance Imaging (MRI) of spinal column (head to hip).
Randomized to one of three groups:
Group 1: will be upper extremity training with transcutaneous spinal stimulation of the spine combined with upper extremity and trunk rehabilitation. The group will complete 60 training sessions transcutaneous spinal stimulation.
Group 2: will be upper extremity training with transcutaneous spinal stimulation of the spine combined with upper extremity and trunk rehabilitation. The group will complete 40 training sessions of transcutaneous spinal stimulation. The group will then complete 20 sessions of rehabilitation therapy of the upper extremities and trunk (no stimulation).
Group 3: will be will be upper extremity training with transcutaneous spinal stimulation of the spine combined with upper extremity and trunk rehabilitation. The group will complete 20 training sessions of transcutaneous spinal stimulation. The group will then complete 40 sessions of rehabilitation therapy of the upper extremities and trunk (no stimulation).
Transcutaneous spinal stimulation will involve stimulating the spinal segments between C5/6 to lumber regions. Training time will be approximately 1 hour, 3-4 times per week.
Rehabilitation therapy will involve exercises concentrating on fingers, hand, arm and trunk function. A physical therapist will be at training and testing sessions.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Randomized into 1 of 3 groups
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
transcutaneous stimulation
Arm Type
Experimental
Arm Description
transcutaneous stimulation 60 sessions
Transcutaneous stimulation 40sessions
Transcutaneous stimulation 20 sessions
Intervention Type
Other
Intervention Name(s)
upper extremity stimulation
Other Intervention Name(s)
Activity-Based Recovery Therapy (ABRT)
Intervention Description
transcutaneous stimulation of the upper extremities
Primary Outcome Measure Information:
Title
Neuro Recovery Scale ( NRS).
Description
Measure of the degree a person who has sustained a spinal cord injury (SCI) has recovered the ability to perform functional tasks relative to how the individual performed these tasks prior to injury. The NRS consists of a numeric version of the visual analog scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. This type of scale can be administered verbally.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age.
spinal cord injury for greater than or equal to 6 months.
spinal cord injury at a cervical neurologic level of injury.
Exclusion Criteria:
ventilator dependent.
history of fractures.
pressure sore or skin issues.
history of illicit drug abuse.
history of cardiac, respiratory, bladder, renal or other medical disorder unrelated to spinal cord injury.
bladder Botox injections less than 12 months prior.
muscle Botox injections less than 12 months prior.
colostomy bag or urostomy.
implanted pump (i.e., baclofen pump, pain pump, etc).
If I am female: I am pregnant at the time of enrollment or planning to become pregnant during the course of the study.
unable to wean from anti-spasticity medication.
contraindications to MRI imaging (pacemaker, metallic foreign body, aneurysm clip, etc.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LeighAnn Martinez, BA
Phone
973.324.3557
Email
lmartinez@kesslerfoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail F Forrest, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Upper Extremity Training for Chronic Cervical Spinal Cord Injury
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