Spinal Cord InjuriesNCT04393922
Spasticity After Spinal Cord Injury
A study testing Acoustic stimuli (Startle) in people with Spinal Cord Injuries, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
Very often, people who have a SCI have difficulty doing things with their arms or hands as a result of muscle stiffness , or spasticity. Spastacity can cause problems performing even the simplest of everyday tasks. This research will help us understand how the body recovers and changes neurologically after SCI. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Acoustic stimuli (Startle)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2020to 18 May 2024
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chronic SCI (≥1 year of injury)
- Incomplete spinal cord injury at T12 or above
- Males and Females
- Ages 18-75 years
- -MAS scores of 0 and 1
- MAS scores of 2, 3 and 4
Show all 23Show fewer
- The ability to perform a voluntary flexion and extension of the elbow and/or knee or ankle
- The ability to reach and grasp an object
- Males and females
- Ages 18-75 years
- Right-handed
- Able to perform elbow and/or knee or ankle flexion and extension
- Exclusion Criteria for individuals with SCI and healthy controls:
- Uncontrolled medical problems including pulmonary, cardiovascular, or orthopedic disease
- Any debilitating disease prior to the SCI that caused exercise intolerance
- Premorbid, ongoing major depression or psychosis, altered cognitive status
- History of head injury or stroke
- Pacemaker
- Metal plate in skull
- History of seizures
- Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants
- Pregnant females
- Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida, or herniated cervical disk
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Monica A Perez, PhD, PT, 312-238-2886, mperez04@sralab.org
About this study
Very often, people who have a SCI have difficulty doing things with their arms or hands as a result of muscle stiffness , or spasticity. Spastacity can cause problems performing even the simplest of everyday tasks. This research will help us understand how the body recovers and changes neurologically after SCI.
Read the detailed description
After spinal cord injury (SCI), damage to descending motor pathways has been associated with the development of spasticity (Frigon and Rossignol, 2006; Trompetto et al., 2014). Self-reported questionnaires and clinical exams indicate that individuals with incomplete SCI, who showed residual descending connectivity, have a high prevalence of spasticity compared to individuals with complete SCI (Little et al., 1989; Holtz et al., 2017). In agreement, our recent electrophysiological and spinal cord imaging data in humans with a diagnosis of a clinically motor complete SCI showed the presence of descending motor pathway connectivity in individuals with spasticity compared to those without spasticity (Sangari et al., 2019). However, which descending motor pathways influence spasticity following SCI, and to what extent, remains poorly understood. This proposal has two main goals: 1) to examine the contribution of cortico- and reticulo-spinal pathways to spasticity in upper and lower limb muscles, and 2) to develop strategies to promote functional recovery of upper and lower limb spastic muscles in humans with chronic incomplete SCI. The aims below will test two main hypotheses.
In Aim 1, we will use transcranial magnetic stimulation and startle acoustic stimuli to examine the contribution of the cortico- and reticulo-spinal pathway to upper and/or lower limb muscles electromyographic activity. Spinal cord atrophy and morphological characterization of cortico- and reticulo-spinal pathways will be assessed with high-resolution magnetic resonance imaging. Physiological and neuroimaging outcomes will be associated with clinical assessment of spasticity.
In Aim 2, we propose to enhance cortico- and reticulo-spinal contribution to upper and/or lower limb function in spastic muscles by using a novel intervention combining startle acoustic stimuli with motor training.
This research will provide new knowledge about the contribution of descending motor pathways to the control of spasticity in upper and lower limb muscles following incomplete cervical SCI (Aim1) and might lead to the development of a novel rehabilitation intervention to improve upper and lower limb motor function recovery by enhancing residual descending control over spinal networks (Aim 2).
- Conditions
- Spinal Cord Injuries
- Being tested
- Acoustic stimuli (Startle)
- Keywords
- Spinal cord injury, Spasticity, TMS
- 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.
Acoustic stimuli (Startle)Behavioural
A startle stimulus (120 dB, 500 Hz, 50 ms) will be delivered through headphones
| Study group | Role | What they receive |
|---|---|---|
| Aim 1 | Experimental | To accomplish this aim, we will conduct one experiment in two sessions separated by 2- 3 days using a crossover design. Participants will be assigned into one of three groups: spastic SCI, non-spastic SCI, and controls. We expect that people enrolled in Aim 1 will complete 2 visits within 1 week.
Visit 1 Measurements:
* MVCs
* MEP Recruitment Curves
* iMEPs
* StartReact
Visit 2 Measurements:
* Participant Reported Spasticity
* MAS
* PSAD
* KINARM
* MRI of brain and spinal cord Receives: Behavioral: Acoustic stimuli (Startle) |
| Aim 2 | Experimental | To accomplish this aim, we will use a randomized crossover design study with spastic SCI participants receiving a single intervention combining non-invasive acoustic stimuli (Startle) or sham-Startle with motor training to enhance cortico- and reticulo-spinal contribution, separated by ~2 weeks.
Visit 1 and Visit 2
Single intervention of:
Startle + exercise training OR sham-Startle + exercise training
Pre and post measurements:
* MVCs
* MEP recruitment curves
* iMEPs
* StartReact
* Participant reported spasticity
* MAS
* PSAD
* KINARM
* Neuromechanical hand and/or leg testing
* GRASSP
* TRI-HFT
* 10-meter walk test
* Pendulum Test Receives: Behavioral: Acoustic stimuli (Startle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MEP recruitment curves
Ten stimuli (0.2 Hz) will be delivered at each intensity to plot the mean peak-to-peak amplitude of the MEP from the non-rectified response against the TMS intensity in each subject (MEP recruitment curve).
Measured: 3-4 hours
Ipsilateral MEPs (iMEPs)
Ten stimuli will be delivered during head straight and ten stimuli will be delivered during lateral head rotation, randomly alternated (0.2 Hz).
Measured: 3-4 hours
StartReact
Here, participants will be asked to observe a light-emitting diode (LED) located in front of their head. When the LED will illuminate, individuals will be asked to move their arm or leg. In some trials, the LED will be presented with either a quiet acoustic stimulus (80 dB, 500 Hz, 50 ms) or a startling acoustic stimulus (SAS, 120 dB, 500 Hz, 50 ms) delivered through a headphone.
Measured: 3-4 hours
Participant reported spasticity
Spasticity questionnaire
Measured: 3-4 hours
Modified Ashworth Scale (MAS)
This scale measures resistance encountered during manual passive muscle stretching using a six-point ordinal scale.
Measured: 3-4 hours
Portable Spasticity Assessment Device (PSAD)'
The PSAD combine biomechanical and electrophysiological measurements for an objective quantification of active and passive component of muscle stiffness
Measured: 3-4 hours
Pendulum Test
As part of the physical exam, we will use the pendulum test to measure muscle tone at the knee by using gravity to provoke muscle stretch reflexes during passive swinging of the lower limb.
Measured: 3-4 hours
10-meter walk test
10-meter walk test will be used to assess walking speed
Measured: 3-4 hours
Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP).
This exam measures clinical impairment that incorporates three domains vital to upper-limb function: sensation, strength, and prehension.
Measured: 3-4 hours
Toronto Rehabilitation Institute-Hand Function Test (TRI-HFT)
This exam measures gross motor function frequently used to manipulate objects that participants may encounter in their daily lives.
Measured: 3-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start13 May 2020
- Primary completion18 Jun 2023 (estimated)
- Study completion18 May 2024 (estimated)
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Perez, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393922
- Sponsor's protocol ID
- STU00212201
- Status last verified
- Jun 2022
- First submitted
- 14 May 2020
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spasticity After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04393922
- Acronym / sponsor ID
- STU00212201
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal cord injury, Spasticity, TMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 13 May 2020 (actual)
- Primary completion
- 18 Jun 2023 (estimated)
- Study completion
- 18 May 2024 (estimated)
- First posted
- 19 May 2020 (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.
Very often, people who have a SCI have difficulty doing things with their arms or hands as a result of muscle stiffness , or spasticity. Spastacity can cause problems performing even the simplest of everyday tasks. This research will help us understand how the body recovers and changes neurologically after SCI.
Detailed description
After spinal cord injury (SCI), damage to descending motor pathways has been associated with the development of spasticity (Frigon and Rossignol, 2006; Trompetto et al., 2014). Self-reported questionnaires and clinical exams indicate that individuals with incomplete SCI, who showed residual descending connectivity, have a high prevalence of spasticity compared to individuals with complete SCI (Little et al., 1989; Holtz et al., 2017). In agreement, our recent electrophysiological and spinal cord imaging data in humans with a diagnosis of a clinically motor complete SCI showed the presence of descending motor pathway connectivity in individuals with spasticity compared to those without spasticity (Sangari et al., 2019). However, which descending motor pathways influence spasticity following SCI, and to what extent, remains poorly understood. This proposal has two main goals: 1) to examine the contribution of cortico- and reticulo-spinal pathways to spasticity in upper and lower limb muscles, and 2) to develop strategies to promote functional recovery of upper and lower limb spastic muscles in humans with chronic incomplete SCI. The aims below will test two main hypotheses.
In Aim 1, we will use transcranial magnetic stimulation and startle acoustic stimuli to examine the contribution of the cortico- and reticulo-spinal pathway to upper and/or lower limb muscles electromyographic activity. Spinal cord atrophy and morphological characterization of cortico- and reticulo-spinal pathways will be assessed with high-resolution magnetic resonance imaging. Physiological and neuroimaging outcomes will be associated with clinical assessment of spasticity.
In Aim 2, we propose to enhance cortico- and reticulo-spinal contribution to upper and/or lower limb function in spastic muscles by using a novel intervention combining startle acoustic stimuli with motor training.
This research will provide new knowledge about the contribution of descending motor pathways to the control of spasticity in upper and lower limb muscles following incomplete cervical SCI (Aim1) and might lead to the development of a novel rehabilitation intervention to improve upper and lower limb motor function recovery by enhancing residual descending control over spinal networks (Aim 2).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim 1 | Experimental | Behavioral: Acoustic stimuli (Startle)To accomplish this aim, we will conduct one experiment in two sessions separated by 2- 3 days using a crossover design. Participants will be assigned into one of three groups: spastic SCI, non-spastic SCI, and controls. We expect that people enrolled in Aim 1 will complete 2 visits within 1 week. Visit 1 Measurements: * MVCs * MEP Recruitment Curves * iMEPs * StartReact Visit 2 Measurements: * Participant Reported Spasticity * MAS * PSAD * KINARM * MRI of brain and spinal cord |
| Aim 2 | Experimental | Behavioral: Acoustic stimuli (Startle)To accomplish this aim, we will use a randomized crossover design study with spastic SCI participants receiving a single intervention combining non-invasive acoustic stimuli (Startle) or sham-Startle with motor training to enhance cortico- and reticulo-spinal contribution, separated by ~2 weeks. Visit 1 and Visit 2 Single intervention of: Startle + exercise training OR sham-Startle + exercise training Pre and post measurements: * MVCs * MEP recruitment curves * iMEPs * StartReact * Participant reported spasticity * MAS * PSAD * KINARM * Neuromechanical hand and/or leg testing * GRASSP * TRI-HFT * 10-meter walk test * Pendulum Test |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Chronic SCI (≥1 year of injury)
- Incomplete spinal cord injury at T12 or above
- Males and Females
- Ages 18-75 years
- -MAS scores of 0 and 1
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Acoustic stimuli (Startle)A startle stimulus (120 dB, 500 Hz, 50 ms) will be delivered through headphones | Behavioural | Aim 1, Aim 2 |
Primary outcome
MEP recruitment curves
Time frame: 3-4 hours
Ten stimuli (0.2 Hz) will be delivered at each intensity to plot the mean peak-to-peak amplitude of the MEP from the non-rectified response against the TMS intensity in each subject (MEP recruitment curve).
Ipsilateral MEPs (iMEPs)
Time frame: 3-4 hours
Ten stimuli will be delivered during head straight and ten stimuli will be delivered during lateral head rotation, randomly alternated (0.2 Hz).
StartReact
Time frame: 3-4 hours
Here, participants will be asked to observe a light-emitting diode (LED) located in front of their head. When the LED will illuminate, individuals will be asked to move their arm or leg. In some trials, the LED will be presented with either a quiet acoustic stimulus (80 dB, 500 Hz, 50 ms) or a startling acoustic stimulus (SAS, 120 dB, 500 Hz, 50 ms) delivered through a headphone.
Participant reported spasticity
Time frame: 3-4 hours
Spasticity questionnaire
Modified Ashworth Scale (MAS)
Time frame: 3-4 hours
This scale measures resistance encountered during manual passive muscle stretching using a six-point ordinal scale.
Portable Spasticity Assessment Device (PSAD)'
Time frame: 3-4 hours
The PSAD combine biomechanical and electrophysiological measurements for an objective quantification of active and passive component of muscle stiffness
Pendulum Test
Time frame: 3-4 hours
As part of the physical exam, we will use the pendulum test to measure muscle tone at the knee by using gravity to provoke muscle stretch reflexes during passive swinging of the lower limb.
10-meter walk test
Time frame: 3-4 hours
10-meter walk test will be used to assess walking speed
Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP).
Time frame: 3-4 hours
This exam measures clinical impairment that incorporates three domains vital to upper-limb function: sensation, strength, and prehension.
Toronto Rehabilitation Institute-Hand Function Test (TRI-HFT)
Time frame: 3-4 hours
This exam measures gross motor function frequently used to manipulate objects that participants may encounter in their daily lives.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acoustic stimuli (Startle) in people with Spinal Cord Injuries, run by Shirley Ryan AbilityLab 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 23 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 22 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sina Sangari, PhD (312.238.1365, ssangari@rsralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MEP recruitment curves (time frame: 3-4 hours). The study lists 10 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 22 Jun 2022.