Back to resultsInfluence of Wearable Intensive Nerve Stimulation on Spasticity and Function in Persons With Spinal Cord Injury
Primary Purpose
Spinal Cord Injuries, Spasticity, Muscle
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wearable intensive nerve stimulator
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries
Eligibility Criteria
Inclusion Criteria:
- Be 18-65 years of age
- Have sustained cervical or thoracic SCI at least 6 months prior to initiating participation in study
- Any ISNCSCI severity classification (A, B, C, or D)
- Have self-reported spasticity and at the time of screening demonstrate an FSE angle of ≤ 75 degrees on the pendulum test or ≥ 4 beats of clonus on the drop test
- May participate if utilizing oral prescription medications for control of spasticity
- Ability and willingness to consent and authorize use of personal health information
Exclusion Criteria:
- Severe contractures of the leg/foot to be stimulated (decided during pre-assessment) that limit passive movement of the hip, knee, or ankle more than 50% of normal range of motion or presence of other orthopedic pathology that would adversely influence participation in the protocol
- Any implanted catheter such as but not limited to CSF shunt, baclofen pump, or the presence of a pacemaker, implanted automatic internal cardioverter defibrillator (AICD, other cardiac implants and or conditions)
- Severe pain or hypersensitivity of the leg to be stimulated (decided during pre-assessment)
- Uncontrolled edema of the leg to be stimulated (decided during pre-assessment)
- Current pregnancy
- Lumbar spinal cord injury level
- Inability or unwillingness to consent and authorize use of personal health information
Sites / Locations
- Shepherd Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Wearable intensive nerve stimulation
Arm Description
The device will be worn on the upper calf with each session of stimulation lasting 60 minutes after which the device will turn off for 60 minutes before turning back on. Participants will be instructed to wear the device for 5 hours a day in order to receive three one our sessions of stimulation.
Outcomes
Primary Outcome Measures
Change in Spasticity
Instrumented Pendulum Test: Participants will be in a semi-reclined position on a therapy mat. The examiner will then bring the participants knee into full extension before dropping the foot. The examiner will observe the number of oscillations to determine muscle stretch-induced activity
Satisfaction and Adherence Questionnaire
Participant will answer questions about how likely they would be to continue to use the intervention at home.
Spinal Cord Injury - Spasticity Evaluation Tool
a Questionnaire used to characterize the impact of spasticity on a participant's ability to perform everyday occupations.
Secondary Outcome Measures
Manual Ankle Clonus Test
Participants are positioned in supine with legs extended. The examine will move each foot individually into dorsiflexion and observe the number of beats of clonus. This will be used to determine muscle-stretch induced activity of the lower limb
Ankle Drop Test
Participants are seated on the edge of the table with one leg fully extended. The examiner holds the test leg 10 cm above a wooden block before dropping it onot the block to observe the duration of clonus if there is any. The test will determine muscle-stretch induced activity.
Flexor Spasms
Participants are in supine with the hip and knee extended. The examiner will then stimulate the foot with a safety pin and observe movement of the great toe, ankle dorsiflexion, and hip and knee flexion. This tool is used to determine spasticity
Instrumented Flexor Reflex Response
Participants will be positioned in supine with knee and hip extended. The examiner will stimulate the foot with an electrical stimulus and observe movement of the great toe, ankle dorsiflexion, and hip and knee flexion. The tool is used to determine spasticity in the lower limb.
Global Impression of Change Scale
a self-report measure designed to quantify the participant's improvement or deterioration over time. This tool will be used to rate how spasticity is impacting the participant's function. The scale is an 11 point scale from -5, representing that spasticity is much worse, to 5, which reports that spasticity is much better. Participants will use this scale to evaluate spasticity at the ankle, hip, and knee.
Adherence Data
Adherence data will be collected from the device, which stores data on duration and number of therapy sessions completed each day. This tool will be used to measure participant adherence.
Assessing neurophysiological aspects of spasticity
Electrodes will be placed on the quadriceps, hamstring, tibialis anterior, and soleus muscles to observe muscle activity during rest and testing. Biomechanical measurements of lower extremity movement will be made using inertial motion capture equipment (Xsens)
Full Information
NCT ID
NCT04130295
First Posted
October 7, 2019
Last Updated
July 26, 2021
Sponsor
Shepherd Center, Atlanta GA
Collaborators
Emory University
1. Study Identification
Unique Protocol Identification Number
NCT04130295
Brief Title
Influence of Wearable Intensive Nerve Stimulation on Spasticity and Function in Persons With Spinal Cord Injury
Official Title
Influence of Wearable Intensive Nerve Stimulation on Spasticity and Function in Persons With Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
March 25, 2021 (Actual)
Study Completion Date
March 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shepherd Center, Atlanta GA
Collaborators
Emory University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Spasticity is muscle spasms, bouncing (clonus) or stiffness that can negatively impact the quality of life of people with spinal cord injury (SCI). In people with spinal cord injury, spasticity can limit muscle control of the arms and hands and cause pain, discomfort, and frustration. Transcutaneous electrical stimulation has been shown to reduce spasticity after SCI. However, this type of stimulation's effects during prolonged, at-home use has not been well studied. Additionally, traditional stimulation techniques are often only available in the clinic. Therefore, this study aims to identify if wearable intensive nerve stimulation decreases spasticity in the legs of people with SCI, and if this intervention is usable and desirable to individuals with SCI.
Detailed Description
Involuntary muscle activation, also referred to as spasticity is a common characteristic of spinal cord injuries. It can present as stiffness, clonus, and spasms that can impact a person's ability to perform daily tasks. Over half of individuals with spinal cord injuries that have spasticity report medication alone does not control the spasticity. Because of this clinical research is investigation different ways to manage spasticity.
Stretching and vibration have demonstrated the ability to reduce spasticity but only for short periods of time requiring repeated use of the intervention. Additionally, vibration devices are not very practical to implement at home due to their high cost. Due to these factors, a solution that could be used multiple times a day and remains cost effective is needed.
Transcutaneous electrical stimulation (TENS) has also demonstrated effectiveness in reducing spasticity after one session but shows greater benefit when it is able to be used for multiple sessions. A wearable intensive nerve stimulator (WINS) device has been shown to be safe for daily wear which makes it a feasible solution to address spasticity at home. Research has not yet looked at the efficacy of using the WINS device for spasticity and this study proposes to begin to fill that gap.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Spasticity, Muscle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wearable intensive nerve stimulation
Arm Type
Experimental
Arm Description
The device will be worn on the upper calf with each session of stimulation lasting 60 minutes after which the device will turn off for 60 minutes before turning back on. Participants will be instructed to wear the device for 5 hours a day in order to receive three one our sessions of stimulation.
Intervention Type
Other
Intervention Name(s)
Wearable intensive nerve stimulator
Intervention Description
The wearable device consists of 2 leads that provide biphasic, with alternating lead phase, asymmetrical rectangular current at a pulse duration of 0.28 msec, a randomly varying pulse frequency between 60-100 Hz, with a maximum intensity of 100mA.
Primary Outcome Measure Information:
Title
Change in Spasticity
Description
Instrumented Pendulum Test: Participants will be in a semi-reclined position on a therapy mat. The examiner will then bring the participants knee into full extension before dropping the foot. The examiner will observe the number of oscillations to determine muscle stretch-induced activity
Time Frame
Week 1, Week 2, Week 3, and Week 7
Title
Satisfaction and Adherence Questionnaire
Description
Participant will answer questions about how likely they would be to continue to use the intervention at home.
Time Frame
Week 7
Title
Spinal Cord Injury - Spasticity Evaluation Tool
Description
a Questionnaire used to characterize the impact of spasticity on a participant's ability to perform everyday occupations.
Time Frame
Twice per week
Secondary Outcome Measure Information:
Title
Manual Ankle Clonus Test
Description
Participants are positioned in supine with legs extended. The examine will move each foot individually into dorsiflexion and observe the number of beats of clonus. This will be used to determine muscle-stretch induced activity of the lower limb
Time Frame
Week 1, Week 2, Week 3, and Week 7
Title
Ankle Drop Test
Description
Participants are seated on the edge of the table with one leg fully extended. The examiner holds the test leg 10 cm above a wooden block before dropping it onot the block to observe the duration of clonus if there is any. The test will determine muscle-stretch induced activity.
Time Frame
Week 1, Week 2, Week 3, and Week 7
Title
Flexor Spasms
Description
Participants are in supine with the hip and knee extended. The examiner will then stimulate the foot with a safety pin and observe movement of the great toe, ankle dorsiflexion, and hip and knee flexion. This tool is used to determine spasticity
Time Frame
Week 1, Week 2, Week 3, and Week 7
Title
Instrumented Flexor Reflex Response
Description
Participants will be positioned in supine with knee and hip extended. The examiner will stimulate the foot with an electrical stimulus and observe movement of the great toe, ankle dorsiflexion, and hip and knee flexion. The tool is used to determine spasticity in the lower limb.
Time Frame
Week 1, Week 2, Week 3, and Week 7
Title
Global Impression of Change Scale
Description
a self-report measure designed to quantify the participant's improvement or deterioration over time. This tool will be used to rate how spasticity is impacting the participant's function. The scale is an 11 point scale from -5, representing that spasticity is much worse, to 5, which reports that spasticity is much better. Participants will use this scale to evaluate spasticity at the ankle, hip, and knee.
Time Frame
Week 1, Week 2, Week 3, and Week 7
Title
Adherence Data
Description
Adherence data will be collected from the device, which stores data on duration and number of therapy sessions completed each day. This tool will be used to measure participant adherence.
Time Frame
Week 3, Week 4, Week 5, and Week 7
Title
Assessing neurophysiological aspects of spasticity
Description
Electrodes will be placed on the quadriceps, hamstring, tibialis anterior, and soleus muscles to observe muscle activity during rest and testing. Biomechanical measurements of lower extremity movement will be made using inertial motion capture equipment (Xsens)
Time Frame
Week 1, Week 2, Week 3, and Week 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be 18-65 years of age
Have sustained cervical or thoracic SCI at least 6 months prior to initiating participation in study
Any ISNCSCI severity classification (A, B, C, or D)
Have self-reported spasticity and at the time of screening demonstrate an FSE angle of ≤ 75 degrees on the pendulum test or ≥ 4 beats of clonus on the drop test
May participate if utilizing oral prescription medications for control of spasticity
Ability and willingness to consent and authorize use of personal health information
Exclusion Criteria:
Severe contractures of the leg/foot to be stimulated (decided during pre-assessment) that limit passive movement of the hip, knee, or ankle more than 50% of normal range of motion or presence of other orthopedic pathology that would adversely influence participation in the protocol
Any implanted catheter such as but not limited to CSF shunt, baclofen pump, or the presence of a pacemaker, implanted automatic internal cardioverter defibrillator (AICD, other cardiac implants and or conditions)
Severe pain or hypersensitivity of the leg to be stimulated (decided during pre-assessment)
Uncontrolled edema of the leg to be stimulated (decided during pre-assessment)
Current pregnancy
Lumbar spinal cord injury level
Inability or unwillingness to consent and authorize use of personal health information
Facility Information:
Facility Name
Shepherd Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Influence of Wearable Intensive Nerve Stimulation on Spasticity and Function in Persons With Spinal Cord Injury
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