Spinal Cord InjuriesSCS_CorE_ATNCT03886857
Segmental Mechanisms of Transcutaneous Spinal Cord Stimulation for Spasticity Control
A study testing transcutaneous spinal cord stimulation in people with Spinal Cord Injuries, run by Peter Lackner at 2 sites in Austria.
Trial summary
The aim of the pilot study is to gain first insights into the interaction of transcutaneous spinal cord stimulation with the altered activity of intraspinal circuits associated with spinal spasticity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- transcutaneous spinal cord stimulation
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 2 sitesAustria
- Study dates
- 1 May 2019to 1 Oct 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- written informed consent prior to participation
- for participants with intact CNS:
- no previous neurological or musculoskeletal disorders
- for participants with spinal cord injury:
- Spinal cord injury due to trauma
- ≥ 12 months post-spinal cord injury
Show all 9Show fewer
- complete or incomplete spinal cord injury classified as grade C or D on the American Spinal Injury Association Impairment Scale (AIS)
- neurological level of spinal cord injury: C3-T10
- preserved tendon and cutaneo-muscular reflexes in the lower limbs
Who cannot join
- other neuromuscular diseases, e.g., amyotrophic lateral sclerosis (ALS), Parkinson's disease, Guillain-Barré syndrome, muscular dystrophy
- active implants (e.g., cardiac pacemaker, drug pump)
- passive implants at vertebral level T10 or caudal (e.g., metal screws/plates for surgical stabilization of spinal fractures)
- active infections or diseases, pressure sores
- dermatological issues at the stimulation site
- malignant diseases
- heart insufficiency (NYHA III-IV)
- potential pregnancy (pregnancy test to be conducted in women of child bearing age before application of transcutaneous spinal cord stimulation)
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Medical University of Vienna
Vienna, 1090
Klinik Floridsdorf
Vienna, 1210
About this study
Official title: Carry-over Effects of Transcutaneous Spinal Cord Stimulation for Spasticity Control on Inhibitory Circuits of the Spinal Cord: a Pilot Study
The aim of the pilot study is to gain first insights into the interaction of transcutaneous spinal cord stimulation with the altered activity of intraspinal circuits associated with spinal spasticity. The main goal is to evaluate the validity of the chosen measures and to generate a data base for statistical planning of a subsequent clinical study.
- Conditions
- Spinal Cord Injuries
- Being tested
- transcutaneous spinal cord stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous spinal cord stimulationDevice
noninvasive electrical stimulation of the human lumbar spinal cord
What is being measured
The primary outcome is the main question the study is designed to answer.
Postsynaptic inhibition
reciprocal inhibition of the soleus H-reflex
Measured: pre-intervention to 2 hours post-intervention
Secondary outcomes (4)
Presynaptic inhibition
induced D1 inhibition and ongoing presynaptic inhibition of the soleus-H reflex
Measured: pre-intervention to 2 hours post-intervention
H_max/M_max
Ratio of the maximum H reflex and the maximum M wave
Measured: pre-intervention to 2 hours post-intervention
Low-frequency depression
rate-dependent depression of the soleus H-reflex
Measured: pre-intervention to 2 hours post-intervention
Evaluation of lower-limb spasticity
surface-electromyography based assessments
Measured: pre-intervention to 2 hours post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start1 May 2019
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Lackner
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna
- Responsible party
- Sponsor-investigator, Peter Lackner, Klinikum Floridsdorf
- Investigators
- Ursula Hofstoetter, Prof., PhD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886857
- Sponsor's protocol ID
- SCS-CorE_AT
- Acronym
- SCS_CorE_AT
- Status last verified
- Oct 2024
- First submitted
- 18 Mar 2019
- Last updated
- 15 Oct 2024
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carry-over Effects of Transcutaneous Spinal Cord Stimulation for Spasticity Control on Inhibitory Circuits of the Spinal Cord: a Pilot Study
- ClinicalTrials.gov ID
- NCT03886857
- Acronym / sponsor ID
- SCS_CorE_AT / SCS-CorE_AT
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Peter LacknerUniversity, hospital or other
- Collaborators
- Medical University of Vienna
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 22 Mar 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.
The aim of the pilot study is to gain first insights into the interaction of transcutaneous spinal cord stimulation with the altered activity of intraspinal circuits associated with spinal spasticity. The main goal is to evaluate the validity of the chosen measures and to generate a data base for statistical planning of a subsequent clinical study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- written informed consent prior to participation
- no previous neurological or musculoskeletal disorders
- Spinal cord injury due to trauma
- ≥ 12 months post-spinal cord injury
- complete or incomplete spinal cord injury classified as grade C or D on the American Spinal Injury Association Impairment Scale (AIS)
Key exclusion criteria (8 listed)
- other neuromuscular diseases, e.g., amyotrophic lateral sclerosis (ALS), Parkinson's disease, Guillain-Barré syndrome, muscular dystrophy
- active implants (e.g., cardiac pacemaker, drug pump)
- passive implants at vertebral level T10 or caudal (e.g., metal screws/plates for surgical stabilization of spinal fractures)
- active infections or diseases, pressure sores
- dermatological issues at the stimulation site
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 |
|---|---|---|
| transcutaneous spinal cord stimulationnoninvasive electrical stimulation of the human lumbar spinal cord | Device | – |
Primary outcome
Postsynaptic inhibition
Time frame: pre-intervention to 2 hours post-intervention
reciprocal inhibition of the soleus H-reflex
4 secondary outcomes
Presynaptic inhibition
Time frame: pre-intervention to 2 hours post-intervention
H_max/M_max
Time frame: pre-intervention to 2 hours post-intervention
Low-frequency depression
Time frame: pre-intervention to 2 hours post-intervention
Evaluation of lower-limb spasticity
Time frame: pre-intervention to 2 hours post-intervention
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 15 Oct 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. This study is not recruiting at the moment.
Ursula Hofstoetter, Prof., PhD principal investigator
Medical University of Vienna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous spinal cord stimulation in people with Spinal Cord Injuries, run by Peter Lackner at 2 sites in Austria.
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 9 inclusion and 8 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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?
Postsynaptic inhibition (time frame: pre-intervention to 2 hours post-intervention). 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 15 Oct 2024.