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Upper Extremity Training for Chronic Cervical Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04921592
Recruitment Status : Not yet recruiting
First Posted : June 10, 2021
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
Gail Forrest, Kessler Foundation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: upper extremity stimulation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Randomized into 1 of 3 groups
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Neuromodulation Training for Upper Extremity Recovery for Chronic Cervical Spinal Cord Injury
Estimated Study Start Date : June 14, 2021
Estimated Primary Completion Date : June 15, 2022
Estimated Study Completion Date : November 15, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: transcutaneous stimulation
  1. transcutaneous stimulation 60 sessions
  2. Transcutaneous stimulation 40sessions
  3. Transcutaneous stimulation 20 sessions
 Other: upper extremity stimulation
transcutaneous stimulation of the upper extremities
Other Name: Activity-Based Recovery Therapy (ABRT)


Outcome Measures
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Primary Outcome Measures :
  1. Neuro Recovery Scale ( NRS). [ Time Frame: 6 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04921592


Contacts
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Contact: LeighAnn Martinez, BA 973.324.3557 lmartinez@kesslerfoundation.org

Sponsors and Collaborators
Kessler Foundation
Investigators
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Principal Investigator: Gail F Forrest, PhD Kessler Foundation
More Information
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Responsible Party: Gail Forrest, Director, Center for Spinal Stimulation, Kessler Foundation
ClinicalTrials.gov Identifier: NCT04921592    
Other Study ID Numbers: R-1153-21
First Posted: June 10, 2021    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System