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Influence of Transcutaneous Spinal Cord Stimulation Intensity on Spasticity After SCI

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: NCT04243044
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Edelle Field-Fote, PT, PhD, Shepherd Center, Atlanta GA

Brief Summary:
Transcutaneous spinal cord stimulation (tcSCS) is a form of electrical stimulation delivered over the skin of the spine that may be valuable for reducing spasticity without the side effects of antispasticity medications. The intensity of stimulation, or dose, that promotes the best response is not known. Understanding the response to different intensities of stimulation and how they affect spasticity will help guide rehabilitation for persons with SCI. Therefore, this study aims to identify the effects tcSCS as a non-drug intervention for spasticity management.

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

Detailed Description:
Spasticity involves involuntary muscle activity in persons with spinal cord injury (SCI) that can include increased response to muscle stretch and physical touch, as well as muscle stiffness. Due to the combination of symptoms, several drug therapies are currently prescribed to reduce spasticity but they may have negative side effects including fatigue and muscle weakness. Transcutaneous spinal cord stimulation (tcSCS) is a form of electrical stimulation delivered over the skin of the spine to that seem to have effects that are similar to drug therapy. Prior studies of tcSCS in persons with SCI suggest that tcSCS can reduce spasticity without negative side effects. The intensity of stimulation, or dose, that promotes the best response is not known. In addition sensitive measurements are necessary to assess the changes that can be seen in multiple presentations of spasticity. Understanding the response to different intensities of stimulation and how they affect spasticity will help guide rehabilitation for persons with SCI. Therefore, this study aims to identify the effects tcSCS as a non-drug intervention for spasticity management.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Dose-Response Effects Associated With Intensity of Transcutaneous Spinal Cord Stimulation on Spasticity After Spinal Cord Injury
Actual Study Start Date : January 20, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intensity 1 (0.8x resting threshold, 30 minute duration)
Transcutaneous spinal cord stimulation will be applied continually at 0.8x resting threshold as determined from baseline testing of posterior root muscle reflexes.
Device: Transcutaneous spinal cord stimulation
Transcutaneous spinal cord stimulation will be delivered for 30 minutes using cathodal stimulation with a single round electrode placed directly over the spine at the T11/T12 spinous interspace, and a dispersive (reference) electrode placed over the umbilicus. For assessing different stimulation intensities, tcSCS will be delivered at frequency of 50Hz. Stimulation intensity will be set to the specified level determined through a pre-stimulation assessment (constant stimulation at 0.8x resting threshold, constant stimulation at 1.2x resting threshold, bursting stimulation at 0.8x resting threshold). For assessment of varying stimulation frequencies (30, 50, 80 Hz), tcSCS will be delivered at 0.8xRT for 30 minutes. Treatments will be a minimum of 48 hours apart.

Experimental: Intensity 2 (1.2x resting threshold, 30 minute duration)
Transcutaneous spinal cord stimulation will be applied continually at 1.2x resting threshold as determined from baseline testing of posterior root muscle reflexes.
Device: Transcutaneous spinal cord stimulation
Transcutaneous spinal cord stimulation will be delivered for 30 minutes using cathodal stimulation with a single round electrode placed directly over the spine at the T11/T12 spinous interspace, and a dispersive (reference) electrode placed over the umbilicus. For assessing different stimulation intensities, tcSCS will be delivered at frequency of 50Hz. Stimulation intensity will be set to the specified level determined through a pre-stimulation assessment (constant stimulation at 0.8x resting threshold, constant stimulation at 1.2x resting threshold, bursting stimulation at 0.8x resting threshold). For assessment of varying stimulation frequencies (30, 50, 80 Hz), tcSCS will be delivered at 0.8xRT for 30 minutes. Treatments will be a minimum of 48 hours apart.

Experimental: Intensity 3 (burst 0.8x rest threshold, 30 minute duration)
Transcutaneous spinal cord stimulation will be applied in bursts at 0.8x resting threshold as determined from baseline testing of posterior root muscle reflexes.
Device: Transcutaneous spinal cord stimulation
Transcutaneous spinal cord stimulation will be delivered for 30 minutes using cathodal stimulation with a single round electrode placed directly over the spine at the T11/T12 spinous interspace, and a dispersive (reference) electrode placed over the umbilicus. For assessing different stimulation intensities, tcSCS will be delivered at frequency of 50Hz. Stimulation intensity will be set to the specified level determined through a pre-stimulation assessment (constant stimulation at 0.8x resting threshold, constant stimulation at 1.2x resting threshold, bursting stimulation at 0.8x resting threshold). For assessment of varying stimulation frequencies (30, 50, 80 Hz), tcSCS will be delivered at 0.8xRT for 30 minutes. Treatments will be a minimum of 48 hours apart.

Experimental: Frequency 1 (30 Hz, 30 minute duration)
Transcutaneous spinal cord stimulation will be applied at a frequency of 30 Hz and an intensity of 0.8x resting threshold as determined from baseline testing of posterior root muscle reflexes.
Device: Transcutaneous spinal cord stimulation
Transcutaneous spinal cord stimulation will be delivered for 30 minutes using cathodal stimulation with a single round electrode placed directly over the spine at the T11/T12 spinous interspace, and a dispersive (reference) electrode placed over the umbilicus. For assessing different stimulation intensities, tcSCS will be delivered at frequency of 50Hz. Stimulation intensity will be set to the specified level determined through a pre-stimulation assessment (constant stimulation at 0.8x resting threshold, constant stimulation at 1.2x resting threshold, bursting stimulation at 0.8x resting threshold). For assessment of varying stimulation frequencies (30, 50, 80 Hz), tcSCS will be delivered at 0.8xRT for 30 minutes. Treatments will be a minimum of 48 hours apart.

Experimental: Frequency 2 (50 Hz, 30 minute duration)
Transcutaneous spinal cord stimulation will be applied at a frequency of 50 Hz and an intensity of 0.8x resting threshold as determined from baseline testing of posterior root muscle reflexes.
Device: Transcutaneous spinal cord stimulation
Transcutaneous spinal cord stimulation will be delivered for 30 minutes using cathodal stimulation with a single round electrode placed directly over the spine at the T11/T12 spinous interspace, and a dispersive (reference) electrode placed over the umbilicus. For assessing different stimulation intensities, tcSCS will be delivered at frequency of 50Hz. Stimulation intensity will be set to the specified level determined through a pre-stimulation assessment (constant stimulation at 0.8x resting threshold, constant stimulation at 1.2x resting threshold, bursting stimulation at 0.8x resting threshold). For assessment of varying stimulation frequencies (30, 50, 80 Hz), tcSCS will be delivered at 0.8xRT for 30 minutes. Treatments will be a minimum of 48 hours apart.

Experimental: Frequency 3 (80 Hz, 30 minute duration)
Transcutaneous spinal cord stimulation will be applied at a frequency of 80 Hz and an intensity of 0.8x resting threshold as determined from baseline testing of posterior root muscle reflexes.
Device: Transcutaneous spinal cord stimulation
Transcutaneous spinal cord stimulation will be delivered for 30 minutes using cathodal stimulation with a single round electrode placed directly over the spine at the T11/T12 spinous interspace, and a dispersive (reference) electrode placed over the umbilicus. For assessing different stimulation intensities, tcSCS will be delivered at frequency of 50Hz. Stimulation intensity will be set to the specified level determined through a pre-stimulation assessment (constant stimulation at 0.8x resting threshold, constant stimulation at 1.2x resting threshold, bursting stimulation at 0.8x resting threshold). For assessment of varying stimulation frequencies (30, 50, 80 Hz), tcSCS will be delivered at 0.8xRT for 30 minutes. Treatments will be a minimum of 48 hours apart.




Primary Outcome Measures :
  1. Change in posterior-root muscle reflexes [ Time Frame: Before, immediately, and 2 hours after each intervention through study completion, an average of 2 weeks ]
    PRMRs will be assessed to identify the spinal stimulation threshold at which muscle activity occurs in the quadriceps (reflex threshold). Electrode placement as outlined for intervention will be followed for this assessment. Briefly, stimulating pulses of 1ms duration (via a Digitimer DS7A constant current stimulator) will be delivered through the stimulating electrodes and intensity will be gradually increased until a motor event is electrophysiologically observed in the quadriceps. This reflex threshold stimulation intensity will be utilized to set the parameters of the three tcSCS intervention sessions - 80% of reflex threshold (0.8RT) and 120% of reflex threshold(1.2RT).


Secondary Outcome Measures :
  1. Change in Pendulum Test [ Time Frame: Before, immediately, and 2 hours after each intervention through study completion, an average of 2 weeks ]
    The Pendulum test will be performed during which the participant will be positioned supine on a mat with the lower leg hanging over the mat. A member of the study staff will support the participant's extended lower leg and then release the leg allowing it to swing freely. Muscle activity during each maneuver will be recorded using electromyography (EMG) of the quadriceps, hamstrings, tibialis anterior, and soleus muscles of the lower extremity identified as having the greatest spasticity. Biomechanical measurements will be captured through the use of electrogoniometers placed at the knee and ankle joints.

  2. Change in Ankle Clonus Test [ Time Frame: Before, immediately, and 2 hours after each intervention through study completion, an average of 2 weeks ]
    The Ankle clonus test will be performed during which the participant will be seated at the edge of a mat with the lower leg hanging over the mat. A member of the study staff will support the participant's leg above a box and the release the leg allowing the front of the foot to land on the edge of the box. Muscle activity during each maneuver will be recorded using EMG of the tibialis anterior and soleus muscles of the lower extremity identified as having the greatest spasticity. Biomechanical measurements will be captured through the use of electrogoniometers placed at the ankle.

  3. Change in Plantar Flexor Withdrawal Test [ Time Frame: Before, immediately, and 2 hours after each intervention through study completion, an average of 2 weeks ]
    Muscle activity induced through noxious sensory input will be assessed through instrumented flexor withdrawal reflex testing. The noxious sensory stimulus will be standardized through electrocutaneous stimulation to the plantar surface of the participant's foot (parameters: 25mA and 50mA, 500Hz, 20ms train). Muscle activity after each stimuli will be recorded using electromyography (EMG) of the quadriceps, hamstrings, tibialis anterior, and soleus muscles of the lower extremity identified as having the greatest spasticity.



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 authorize use of protected health information (PHI)
  • Be between 18-65 years of age
  • Have a spinal cord injury of any injury severity (AIS A, B, C, or D)
  • Have at least mild "spasticity" affecting lower extremity muscles
  • I may use prescription medications if the dosage has not changed in the last 2 weeks

Exclusion Criteria:

  • Inability or unwillingness to consent and authorize use of PHI
  • Progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord
  • Neurologic level below spinal level T12
  • History of cardiovascular irregularities (e.g. atrial fibrillation)
  • Problems with following instructions
  • Orthopedic pathology that would limit 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 spinal stimulation
  • Persons who have implanted stimulators of any type will be excluded due to unknown potential of electrical stimulation effects (e.g. baclofen pump, epidural spinal stimulator, implanted cardiac defibrillator)
  • 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): NCT04243044


Contacts
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Contact: Evan Sandler, PT 404-404-1137 evan.sandler@shepherd.org

Locations
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United States, Georgia
Shepherd Center, Inc. Recruiting
Atlanta, Georgia, United States, 30309
Contact: Kathy Kreger, CCRP    404-350-7397    Kathy.Kreger@Shepherd.org   
Shepherd Center, Inc. Recruiting
Atlanta, Georgia, United States, 30309
Contact: Edelle Field-Fote, PT, PhD    404-603-4274    Edelle.Field-Fote@Shepherd.org   
Contact: Elizabeth Sasso, PT, DPT    404-350-7551    Elizabeth.sasso@shepherd.org   
Sponsors and Collaborators
Shepherd Center, Atlanta GA
Investigators
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Principal Investigator: Edelle C Field-Fote, PT, PhD Shepherd Center, Atlanta GA
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Responsible Party: Edelle Field-Fote, PT, PhD, Director, Spinal Injury Research & The Hulse Spinal Injury Laboratory, Shepherd Center, Atlanta GA
ClinicalTrials.gov Identifier: NCT04243044    
Other Study ID Numbers: 1343378
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
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: Yes
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