Neurological DisorderNCT04467437
Transcutaneous Stimulation for Neurological Populations
A study testing Gait Training and Transcutaneous Spinal Stimulation in people with Neurological Disorder and Cerebral Palsy, run by University of Washington at 1 site in United States.
Trial summary
The purpose of the study is to evaluate whether non-invasive stimulation over the spinal cord at the neck and/or lower back can improve walking function for people with neurologic conditions. Read more about this study
- Who is it for?
- Ages 4 to 70 years
- Conditions the study is for
- Neurological Disorder, Cerebral Palsy
- What is being tested?
- Gait Training and Transcutaneous Spinal Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- have a neurologic condition
- can walk 20 yards, with or without an assistive device
- have stable medical condition
- are capable of performing simple cued motor tasks and who can follow 2-3 step commands
- have ability to attend up to 5 sessions per week physical therapy sessions and testing activities
- have adequate social support to be able to participate in training and assessment sessions, up to 5 sessions per week, for the duration of up to 11 months within the study period.
- who are volunteering to be involved in this study
- can read and speak English
Who cannot join
- have significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation.
- have cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
- have a history of uncontrolled seizures
- have unhealed fracture or other musculoskeletal impairment that might interfere with lower extremity rehabilitation or testing activities
- are dependent on ventilation support
- have implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc) or drug delivery device (e.g. baclofen pump)
Show all 10Show fewer
- have history of orthopedic surgery in lower extremities or neurosurgery that may be a confounding factor for interpretation of the results (such as tendon transfer, tendon or muscle lengthening for spasticity management, injection therapies to lower extremity muscles, etc.) in last 12 months
- have established osteoporosis and taking medication for osteoporosis treatment.
- have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
- have active cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98115
Siddhi R Shrivastav, siddhis@uw.edu
Chet T Moritz, ctmoritz@uw.edu
About this study
Official title: Transcutaneous Spinal Stimulation With Intensive Gait Training for Individuals With Neurologic Conditions
The purpose of the study is to evaluate whether non-invasive stimulation over the spinal cord at the neck and/or lower back can improve walking function for people with neurologic conditions. Spinal stimulation has been used extensively for individuals with spinal cord injury, and has demonstrated improvements in function. This study will extend this work to other neurologic conditions, such as cerebral palsy and stroke, that also demonstrate similar impairments as spinal cord injury.
The primary aims of this study are to:
Read more
Aim 1: Evaluate impact of spinal stimulation on spasticity and locomotor function.
Aim 2: Investigate participant perceptions of spinal stimulation.
The investigators will be using a cross-over design study to compare intensive training only to intensive training combined with spinal stimulation. After an initial baseline period of up to 4 weeks (Phase I). Participants will have their first intervention phase of the study (Phase II). This will involve either intensive training only (Condition A) or intensive training combined with spinal stimulation (Condition B). This will be followed by a washout period with no intervention (Phase III) and then the second intervention phase (Phase IV). The second intervention phase will involve either Condition A or Condition B, whichever the participants did not received during Phase II. Phases II-IV will each last up to 8 weeks. After the intervention period is complete, the participant will be asked to come for follow-up visits up to 3 months after the intervention phases are completed (Phase V).
- Conditions
- Neurological Disorder, Cerebral Palsy
- Being tested
- Gait Training, Transcutaneous Spinal Stimulation
- Keywords
- Spinal Electrical Stimulation, Treadmill Training
- Medical subject headings
- Nervous System Diseases, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait TrainingOther
Training that targets rehabilitation of walking function
Transcutaneous Spinal StimulationDevice
Non-invasive electrical stimulation of the spinal cord over the skin combined with gait training
| Study group | Role | What they receive |
|---|---|---|
| Intensive Training Only | Active comparator | Physical and gait training that targets rehabilitation of walking function. Receives: Other: Gait Training |
| Intensive Training Combined with Spinal Stimulation | Active comparator | Transcutaneous spinal stimulation combined with physical and gait training that targets rehabilitation of walking function. Receives: Other: Gait Training; Device: Transcutaneous Spinal Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline - Six Minute Walk Test
Measure of walking ability. The distance is reported in meters.
Measured: Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.
Change from baseline - Ten Meter Walk Test
The measure of walking ability at fast and self-selected speeds. The walking speed is reported as meters per second.
Measured: Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.
Secondary outcomes (6)
Change from baseline - Kinetic and kinematic gait analysis using three dimensional camera system
Measurement of leg function and walking ability. Joint angle is reported in angle degrees, and velocity is reported in meters per second. Kinematic analysis will able to used to measure gait coordination and spatiotemporal outcomes, such as step length and step time.
Measured: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
Change from baseline - Electromyography recording of lower extremity muscles
Measurement of muscle and nerve functions. The muscle activities are reported in micro-volts.
Measured: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
Change from baseline - Gait Outcomes Assessment List
The patient-reported outcome measure for ambulatory children with cerebral palsy. The Gait Outcomes Assessment List comprises 48 items distributed across 7 subscales and spans all domains of the International Classification of Functioning, Disability, and Health. The score range is between 0 and 100. The higher scores mean a better outcome.
Measured: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
Change from baseline - Timed Up and Go
Measurement of mobility and fall risk. The time to complete the test is recorded in seconds.
Measured: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
Change from baseline - Modified Ashworth and Tardieu Scales
Measurement of spasticity in muscles. The score range is between 0 and 5. The lower scores mean a better outcome.
Measured: Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.
Change from baseline - Patient-Reported Outcomes Measurement Information System Pediatric Profile
Includes six domains. These are depression, Anxiety, Physical Function-Mobility, Pain Interference, Fatigue, and Peer Relationships. Each domain contains 8 items, along with a single item on Pain Intensity scored between 0 to 10.
The score range for each domain is between 1 and 5. The lower scores mean a better outcome.
Measured: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start1 Jan 2021
- Primary completionAug 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Seattle Children's Hospital
- Responsible party
- Principal investigator, Chet Moritz, University of Washington
- Investigators
- Katherine M Steele, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467437
- Sponsor's protocol ID
- STUDY00008896
- Status last verified
- Sep 2024
- First submitted
- 7 Jul 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Spinal Stimulation With Intensive Gait Training for Individuals With Neurologic Conditions
- ClinicalTrials.gov ID
- NCT04467437
- Acronym / sponsor ID
- STUDY00008896
- Conditions
- Neurological Disorder, Cerebral Palsy
- Keywords
- Spinal Electrical Stimulation, Treadmill Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Seattle Children's Hospital
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Jul 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.
The purpose of the study is to evaluate whether non-invasive stimulation over the spinal cord at the neck and/or lower back can improve walking function for people with neurologic conditions. Spinal stimulation has been used extensively for individuals with spinal cord injury, and has demonstrated improvements in function. This study will extend this work to other neurologic conditions, such as cerebral palsy and stroke, that also demonstrate similar impairments as spinal cord injury.
The primary aims of this study are to:
Aim 1: Evaluate impact of spinal stimulation on spasticity and locomotor function.
Aim 2: Investigate participant perceptions of spinal stimulation.
The investigators will be using a cross-over design study to compare intensive training only to intensive training combined with spinal stimulation. After an initial baseline period of up to 4 weeks (Phase I). Participants will have their first intervention phase of the study (Phase II). This will involve either intensive training only (Condition A) or intensive training combined with spinal stimulation (Condition B). This will be followed by a washout period with no intervention (Phase III) and then the second intervention phase (Phase IV). The second intervention phase will involve either Condition A or Condition B, whichever the participants did not received during Phase II. Phases II-IV will each last up to 8 weeks. After the intervention period is complete, the participant will be asked to come for follow-up visits up to 3 months after the intervention phases are completed (Phase V).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Training Only | Active comparator | Other: Gait TrainingPhysical and gait training that targets rehabilitation of walking function. |
| Intensive Training Combined with Spinal Stimulation | Active comparator | Other: Gait Training, Device: Transcutaneous Spinal StimulationTranscutaneous spinal stimulation combined with physical and gait training that targets rehabilitation of walking function. |
Who may qualify
- Ages
- 4 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- have a neurologic condition
- can walk 20 yards, with or without an assistive device
- have stable medical condition
- are capable of performing simple cued motor tasks and who can follow 2-3 step commands
- have ability to attend up to 5 sessions per week physical therapy sessions and testing activities
Key exclusion criteria (10 listed)
- have significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation.
- have cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
- have a history of uncontrolled seizures
- have unhealed fracture or other musculoskeletal impairment that might interfere with lower extremity rehabilitation or testing activities
- are dependent on ventilation support
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 |
|---|---|---|
| Gait TrainingTraining that targets rehabilitation of walking function | Other | Intensive Training Combined with Spinal Stimulation, Intensive Training Only |
| Transcutaneous Spinal StimulationNon-invasive electrical stimulation of the spinal cord over the skin combined with gait training | Device | Intensive Training Combined with Spinal Stimulation |
Primary outcome
Change from baseline - Six Minute Walk Test
Time frame: Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.
Measure of walking ability. The distance is reported in meters.
Change from baseline - Ten Meter Walk Test
Time frame: Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.
The measure of walking ability at fast and self-selected speeds. The walking speed is reported as meters per second.
6 secondary outcomes
Change from baseline - Kinetic and kinematic gait analysis using three dimensional camera system
Time frame: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
Change from baseline - Electromyography recording of lower extremity muscles
Time frame: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
Change from baseline - Gait Outcomes Assessment List
Time frame: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
Change from baseline - Timed Up and Go
Time frame: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
Change from baseline - Modified Ashworth and Tardieu Scales
Time frame: Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.
Change from baseline - Patient-Reported Outcomes Measurement Information System Pediatric Profile
Time frame: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
Katherine M Steele, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait Training and Transcutaneous Spinal Stimulation in people with Neurological Disorder and Cerebral Palsy, run by University of Washington 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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siddhi R Shrivastav, BPTh, MS (973-444-1940, siddhis@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline - Six Minute Walk Test (time frame: Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.). The study lists 2 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 19 Sep 2024.