Spinal Cord InjuriesNCT04130295
Influence of Wearable Intensive Nerve Stimulation on Spasticity and Function in Persons With Spinal Cord Injury
A study testing Wearable intensive nerve stimulator in people with Spinal Cord Injuries and Spasticity, Muscle, run by Shepherd Center, Atlanta GA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries, Spasticity, Muscle
- What is being tested?
- Wearable intensive nerve stimulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2019to 25 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Spasticity, Muscle
- Being tested
- Wearable intensive nerve stimulator
- Medical subject headings
- Spinal Cord Injuries, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable intensive nerve stimulatorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Wearable intensive nerve stimulation | Experimental | 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. Receives: Other: Wearable intensive nerve stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 1, Week 2, Week 3, and Week 7
Satisfaction and Adherence Questionnaire
Participant will answer questions about how likely they would be to continue to use the intervention at home.
Measured: Week 7
Spinal Cord Injury - Spasticity Evaluation Tool
a Questionnaire used to characterize the impact of spasticity on a participant's ability to perform everyday occupations.
Measured: Twice per week
Secondary outcomes (7)
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
Measured: Week 1, Week 2, Week 3, and Week 7
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.
Measured: Week 1, Week 2, Week 3, and Week 7
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
Measured: Week 1, Week 2, Week 3, and Week 7
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.
Measured: Week 1, Week 2, Week 3, and Week 7
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.
Measured: Week 1, Week 2, Week 3, and Week 7
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.
Measured: Week 3, Week 4, Week 5, and Week 7
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)
Measured: Week 1, Week 2, Week 3, and Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start15 Oct 2019
- Primary completion25 Mar 2021
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shepherd Center, Atlanta GA
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130295
- Sponsor's protocol ID
- 787
- Status last verified
- Mar 2021
- First submitted
- 7 Oct 2019
- Last updated
- 27 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Wearable Intensive Nerve Stimulation on Spasticity and Function in Persons With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04130295
- Acronym / sponsor ID
- 787
- Conditions
- Spinal Cord Injuries, Spasticity, Muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Shepherd Center, Atlanta GAUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wearable intensive nerve stimulation | Experimental | Other: Wearable intensive nerve stimulatorThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable intensive nerve stimulatorThe 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. | Other | Wearable intensive nerve stimulation |
Primary outcome
Change in Spasticity
Time frame: Week 1, Week 2, Week 3, and Week 7
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
Time frame: Week 7
Participant will answer questions about how likely they would be to continue to use the intervention at home.
Spinal Cord Injury - Spasticity Evaluation Tool
Time frame: Twice per week
a Questionnaire used to characterize the impact of spasticity on a participant's ability to perform everyday occupations.
7 secondary outcomes
Manual Ankle Clonus Test
Time frame: Week 1, Week 2, Week 3, and Week 7
Ankle Drop Test
Time frame: Week 1, Week 2, Week 3, and Week 7
Flexor Spasms
Time frame: Week 1, Week 2, Week 3, and Week 7
Instrumented Flexor Reflex Response
Time frame: Week 1, Week 2, Week 3, and Week 7
Global Impression of Change Scale
Time frame: Week 1, Week 2, Week 3, and Week 7
Adherence Data
Time frame: Week 3, Week 4, Week 5, and Week 7
Assessing neurophysiological aspects of spasticity
Time frame: Week 1, Week 2, Week 3, and Week 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable intensive nerve stimulator in people with Spinal Cord Injuries and Spasticity, Muscle, run by Shepherd Center, Atlanta GA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spasticity (time frame: Week 1, Week 2, Week 3, and Week 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.