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Spinal Cord Stimulation to Augment Activity Based Therapy

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ClinicalTrials.gov Identifier: NCT03240601
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
Foundation Wings For Life
Information provided by (Responsible Party):
Shepherd Center, Atlanta GA

Brief Summary:

Involuntary muscle activity, often called spasticity, is a common problem following spinal cord injury (SCI) that can make it hard to move. Many things can cause spasticity including: muscle stretch, movement, or it can happen for no reason, and it is often described as an uncontrolled muscle spasm or feeling of stiffness. Drugs are typically used to treat spasticity, but they often have side effects, like muscle weakness, which can add to movement problems. Rehabilitation therapies offer alternatives to drugs for treating involuntary muscle activity, and rehabilitation can also improve daily function and quality of life. These benefits may be greater when several rehabilitation therapies are used together.

Walking ability can be improved with a type of therapy called "locomotor training". This type of therapy may also have the benefit of decreasing spasticity. When locomotor training is combined with electrical stimulation, the benefits of training may be increased. In this study, investigators will use a kind of stimulation called transcutaneous spinal cord stimulation ("tcSCS") to stimulate participants' spinal cord nerves during locomotor training.


Condition or disease Intervention/treatment Phase
Spinal Cord Stimulation Walking Spasticity Human Spinal Cord Injuries Device: Transcutaneous spinal cord stimulation Not Applicable

Detailed Description:

Involuntary muscle activity, often referred to as spasticity, is a common problem following spinal cord injury. Spasticity can be evoked by stimuli or occur spontaneously, and it can manifest as spasms, clonus, or the stiffness associated with hypertonia. While medications are typically used to treat the general symptoms of spasticity, they often have additional side effects, like muscle weakness, that can impede rehabilitation. Physical therapeutics offer an alternative to these drug treatments, but the most effective therapeutic strategy for managing spasticity has not yet been identified. A combination of physical therapeutics may provide the best strategy for managing spasticity while also improving general motor control for functional movements.

Walking ability can be improved through locomotor training, which has also been shown to reduce spasticity. When locomotor training is combined with electrical stimulation, the benefits of training may be increased. To investigate the potential benefits of this combinatorial treatment strategy, investigators will use a kind of electrical stimulation called transcutaneous spinal cord stimulation ("tcSCS") to stimulate spinal cord nerves during locomotor training.

In order to facilitate the translation of study findings into clinical practice, this study uses a pragmatic design, meaning that the study will involve the use of real world clinical settings and practices. Participants will undergo their standard physical therapist directed locomotor training program while receiving transcutaneous spinal cord stimulation (tcSCS) as an additional treatment. The effects of locomotor training alone will be compared to the combination of locomotor training with tcSCS, specifically comparing the effects of these treatments on spasticity and walking function.

Investigators expect that the combination of tcSCS with locomotor training will provide 1) a greater reduction in spasticity and 2) a greater improvement of walking function compared to locomotor training alone.

The findings from this study have the potential to rapidly facilitate the translation of a novel combination treatment for the management of spasticity and improvement of walking function into real world clinical practice.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Influence of Transcutaneous Spinal Cord Stimulation and Locomotor Training on Spasticity and Walking Outcomes After Spinal Cord Injury
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Subthreshold
Individuals will undergo their standard physical therapist directed locomotor training while receiving transcutaneous spinal cord stimulation. The stimulation intensity will briefly ramp up to the lowest intensity that is first detected by the participant and then ramped down to a level no longer detected by the participant. Participants will continue their locomotor training.
Device: Transcutaneous spinal cord stimulation
For tcSCS, a transcutaneous electrical nerve stimulation (TENS) unit is used. A 2 inch diameter round electrode is placed on the skin over T11/T12 (cathode), and a large butterfly electrode is placed on the skin over the umbilicus (anode). Pulse width is set to 400 microseconds at 50 Hz.
Other Name: tcSCS

Experimental: Active
Individuals will undergo their standard physical therapist directed locomotor training while receiving transcutaneous spinal cord stimulation. The stimulation intensity will ramp up slowly to a level that produces parasthesia (tingling) throughout the lower extremity. This intensity will be applied for 30 minutes while participants continue their locomotor training.
Device: Transcutaneous spinal cord stimulation
For tcSCS, a transcutaneous electrical nerve stimulation (TENS) unit is used. A 2 inch diameter round electrode is placed on the skin over T11/T12 (cathode), and a large butterfly electrode is placed on the skin over the umbilicus (anode). Pulse width is set to 400 microseconds at 50 Hz.
Other Name: tcSCS




Primary Outcome Measures :
  1. Change in Spasticity - Pendulum/Leg-drop Test [ Time Frame: Through study completion at 4 weeks ]
    This test measures the amount of spasticity in your leg muscles. You will sit at the edge of a mat with your lower legs hanging over the edge of the mat. Motion capture sensors (Xsens) will be placed on both of your legs to record changes in your knee joint angles when your leg is dropped. The examiner will straighten your leg and then allow it to drop and swing over the edge of the mat. The angle of your knee and the movement of your leg will be recorded as it drops. This will be performed three times for each leg separately.

  2. Change in Walking Function - 10m Walk/Walking Speed [ Time Frame: Through study completion at 4 weeks ]
    You will walk over a mat that contains sensors to measure your walking speed as well as wear motion tracking sensors. You will be allowed to use whatever assistive devices you typically use (e.g., braces, walker, forearm crutches). In addition to walking speed, we will also assess your gait kinematics.


Secondary Outcome Measures :
  1. Change in Spasticity - Ankle Clonus Test/Foot-drop test [ Time Frame: Through study completion at 4 weeks ]
    This test measures the amount of spasticity in your ankle. We will use the motion capture sensors to record your ankle joint angles. For this test you will sit upright. Your leg will be raised and released allowing the front of your foot to land on the edge of a box. The angle of your ankle and movement of your foot will be recorded as it drops and catches on the box. This will be performed three times for each leg separately.

  2. Change in Spasticity - Co-contraction [ Time Frame: Through study completion at 4 weeks ]
    Muscle activity will be recorded using electromyography (EMG) during activities where you move your legs, and activities where your legs are moved by the examiner. Electrodes will be placed on four muscles of your legs (front and back of your thigh and lower leg). you will be asked to move your ankles and extend your legs while we record your muscle activity.

  3. Change in Spasticity - Persistent Involuntary Activity [ Time Frame: Through study completion at 4 weeks ]
    You will be asked to lie on your back for 5 minutes and relax while we record the activity in your muscles using EMG.

  4. Change in Spasticity - Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) Test [ Time Frame: Through study completion at 4 weeks ]
    A trained therapist will perform the SCATS assessment before and after each training session. SCATS assesses 3 aspects of spasticity:

  5. Change in Spasticity - Questionnaires [ Time Frame: Through study completion at 4 weeks ]
    You will be asked a series of questions about your perception of spasticity and how it affects your daily life.

  6. Change in Walking Function - 2 Minute Walk [ Time Frame: Through study completion at 4 weeks ]
    You will walk for 2 minutes overground and we will measure how far you walk.

  7. Change in Heart Rate [ Time Frame: Through study completion at 4 weeks ]
    Your heart rate will be recorded during your training sessions to monitor your effort during training.

  8. Change in Borg Rating of Perceived Exertion (RPE) Scale [ Time Frame: Through study completion at 4 weeks ]
    The Borg RPE scale will be used to assess your perception of the level of exertion during training.

  9. Tolerance of stimulation [ Time Frame: Occurs from week 3 through week 4 (study completion) ]
    Using a 0-10 pain scale, you will be asked your perception of pain during the final 2 weeks of stimulation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability and willingness to consent and/or authorize use of protected health information
  • Be between 18-65 years of age
  • Be enrolled in Spinal Cord Injury In-Patient or Day Program at the Shepherd Center
  • Be eligible for locomotor training at the Shepherd Center
  • Be able to take a step, with or without an assistive device
  • Have a spinal cord injury, completed in-patient rehabilitation, and have been discharged to home
  • Have at least mild "spasticity" affecting leg muscles
  • You may participate if you use prescription medications, including baclofen for control of spasticity

Exclusion Criteria:

  • Inability or unwillingness to consent and/or authorization for use of protected health information
  • Progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord
  • Neurologic level at or below spinal level T12
  • History of cardiovascular irregularities
  • Problems with following instructions
  • Orthopedic problems that would limit your participation in the protocol (e.g. knee or hip flexion contractures of greater than 10 degrees)
  • Women who are pregnant, or who have reason to believe they are or may become pregnant due to unknown risks to the fetus associated with tcSCS
  • Persons who have implanted stimulators/electronic devices of any type will be excluded due to unknown potential of tcSCS effects
  • Active infection of any type, as infection may exacerbate spasticity resulting in inability to identify the influence of the treatment

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): NCT03240601


Contacts
Contact: Stephen P Estes, PhD 4046034967 stephen_estes@shepherd.org

Locations
United States, Georgia
Shepherd Center, Inc. Recruiting
Atlanta, Georgia, United States, 30309
Contact: Kathy Kreger, CCRP    404-350-7397    Kathy_Kreger@Shepherd.org   
Sponsors and Collaborators
Shepherd Center, Atlanta GA
Foundation Wings For Life
Investigators
Principal Investigator: Stephen P Estes, PhD Shepherd Center, Inc

Responsible Party: Shepherd Center, Atlanta GA
ClinicalTrials.gov Identifier: NCT03240601     History of Changes
Other Study ID Numbers: 696
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Spinal Cord Injuries
Muscle Spasticity
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms