Motor ActivityNCT04241406
Transcutaneous Spinal Cord Stimulation in Healthy Subjects to Activate Central Pattern Generator
A study testing Transcutaneous spinal cord stimulation in people with Motor Activity, run by University of Castilla-La Mancha at 3 sites in Spain.
Trial summary
The purpose of this study is to determinate whether the application of transcutaneous spinal cord stimulation produce changes in the excitability of alpha moto neurone in healthy volunteers. Moreover evidence whether the effect of the electric currents can increase muscle strength. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Activity
- What is being tested?
- Transcutaneous spinal cord stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesSpain
- Study dates
- 30 Jan 2019to 31 Mar 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will be volunteer healthy students of Physiotherapy, University of Castilla - La Mancha, older than 18 years.
Who cannot join
- Neuromuscular disease.
- Epilepsy.
- Trauma, surgery or pain affecting the upper limb, shoulder girdle or lumbar área.
- Osteosynthesis material in the upper limb.
- Diabetes.
- Cancer.
Show all 12Show fewer
- Cardiovascular disease.
- Pacemaker or other implanted electrical device.
- Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.
- Presence of tattoos or other external agent introduced into the treatment or assessment area.
- Pregnancy.
- Sensitivity disturbance in lower limb.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Julio
Toledo, 45001
Álvaro
Toledo, 45001
Diego Serrano-Muñoz
Toledo, 45004
About this study
Official title: Transcutaneous Spinal Cord Stimulation in Healthy Subjects to Activate Central Pattern Generator: Double-blind, Randomised, Controlled Clinical Trial.
The purpose of this study is to determinate whether the application of transcutaneous spinal cord stimulation produce changes in the excitability of alpha moto neurone in healthy volunteers. Moreover evidence whether the effect of the electric currents can increase muscle strength.
Read the detailed description
In the last years several experimental studies have evidenced that the transcutaneous spinal cord stimulation (tSCS) can evoque spinal reflex activity. The activation of propioceptive afferent would then activated motoneurons innervated at the same metameric and adjacent levels. The possibility of activating neural networks with non-invasive stimulation method opens a therapeutic window for the treatment of different neurological disorders. So the purpose of this study is quantify the modulation of the excitability of alpha motor neurone when the application of the current is in the central nervous system compared with a sham group.
- Conditions
- Motor Activity
- Being tested
- Transcutaneous spinal cord stimulation
- Keywords
- transcutaneous spinal cor stimulation, neuromodulation, motor activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous spinal cord stimulationDevice
Also called tSCS
Electrodes are placed over the back for a 10 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing current intensity during 30 second and decrease intensity subsequentl
| Study group | Role | What they receive |
|---|---|---|
| transcutaneous spinal cord stimulation | Experimental | Transcutaneous application of electrical (biphasic current, 1ms, 30Hz) stimulation over the back for a 10 minutes session.The intensity of the current will increase until motor reflex threshold. If it will not possible, intensity will be increase until participants report a "strong but comfortable" sensation.
Transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands). Receives: Device: Transcutaneous spinal cord stimulation |
| sham stimulation | Experimental | Electrodes are placed over the back for a 10 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing current intensity during 30 second and decrease intensity subsequently.
Sham transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands). Receives: Device: Transcutaneous spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Motor evoked potential (MEP)
The action potential elicited by transcranial magnetic stimulation of the motor cortex through the scalp. EMG response will be recorded by surface electrodes (Signa lConditioning Electrodes v2.3, Delsys Inc., USA) fixed in quadriceps and tibialis anterior muscles. by the SENIAM protocol (www.seniam.org).
Measured: baseline at 0 min.
During treatment Motor evoked potential (MEP)
The action potential elicited by transcranial magnetic stimulation of the motor cortex through the scalp. EMG response will be recorded by surface electrodes (Signa lConditioning Electrodes v2.3, Delsys Inc., USA) fixed in quadriceps and tibialis anterior muscles. by the SENIAM protocol (www.seniam.org).
Measured: During treatment at 5 min.
Post-treatment 1 Motor evoked potential (MEP)
The action potential elicited by transcranial magnetic stimulation of the motor cortex through the scalp. EMG response will be recorded by surface electrodes (Signa lConditioning Electrodes v2.3, Delsys Inc., USA) fixed in quadriceps and tibialis anterior muscles. by the SENIAM protocol (www.seniam.org).
Measured: At 2 min after treatment.
Post-treatment 2 Motor evoked potential (MEP)
The action potential elicited by transcranial magnetic stimulation of the motor cortex through the scalp. EMG response will be recorded by surface electrodes (Signa lConditioning Electrodes v2.3, Delsys Inc., USA) fixed in quadriceps and tibialis anterior muscles. by the SENIAM protocol (www.seniam.org).
Measured: At 4 min after treatment.
Secondary outcomes (2)
Baseline Strength
Hand dynamometer will be used to measure muscle strength. 3 trial of 3 second of isometric muscle contraction of quadriceps and tibialis anterior will be carried.
Measured: Baseline at 0 min.
Post-treatment Strength
Hand dynamometer will be used to measure muscle strength. 3 trial of 3 second of isometric muscle contraction of quadriceps and tibialis anterior will be carried.
Measured: At 8 min after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start30 Jan 2019
- Primary completion3 Feb 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ActivityStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo
- Responsible party
- Sponsor
- Investigators
- Julio Gómez-Soriano, PhD, Principal investigator, Castilla-La Mancha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241406
- Sponsor's protocol ID
- aamg295
- Status last verified
- Apr 2020
- First submitted
- 22 Jan 2020
- Last updated
- 1 May 2020
- 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 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Spinal Cord Stimulation in Healthy Subjects to Activate Central Pattern Generator: Double-blind, Randomised, Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04241406
- Acronym / sponsor ID
- aamg295
- Conditions
- Motor Activity
- Keywords
- transcutaneous spinal cor stimulation, neuromodulation, motor activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 27 Jan 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 this study is to determinate whether the application of transcutaneous spinal cord stimulation produce changes in the excitability of alpha moto neurone in healthy volunteers. Moreover evidence whether the effect of the electric currents can increase muscle strength.
Detailed description
In the last years several experimental studies have evidenced that the transcutaneous spinal cord stimulation (tSCS) can evoque spinal reflex activity. The activation of propioceptive afferent would then activated motoneurons innervated at the same metameric and adjacent levels. The possibility of activating neural networks with non-invasive stimulation method opens a therapeutic window for the treatment of different neurological disorders. So the purpose of this study is quantify the modulation of the excitability of alpha motor neurone when the application of the current is in the central nervous system compared with a sham group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcutaneous spinal cord stimulation | Experimental | Device: Transcutaneous spinal cord stimulationTranscutaneous application of electrical (biphasic current, 1ms, 30Hz) stimulation over the back for a 10 minutes session.The intensity of the current will increase until motor reflex threshold. If it will not possible, intensity will be increase until participants report a "strong but comfortable" sensation. Transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands). |
| sham stimulation | Experimental | Device: Transcutaneous spinal cord stimulationElectrodes are placed over the back for a 10 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing current intensity during 30 second and decrease intensity subsequently. Sham transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will be volunteer healthy students of Physiotherapy, University of Castilla - La Mancha, older than 18 years.
Key exclusion criteria (12 listed)
- Neuromuscular disease.
- Epilepsy.
- Trauma, surgery or pain affecting the upper limb, shoulder girdle or lumbar área.
- Osteosynthesis material in the upper limb.
- Diabetes.
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 stimulationAlso: tSCSElectrodes are placed over the back for a 10 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing current intensity during 30 second and decrease intensity subsequentl | Device | sham stimulation, transcutaneous spinal cord stimulation |
Primary outcome
Baseline Motor evoked potential (MEP)
Time frame: baseline at 0 min.
The action potential elicited by transcranial magnetic stimulation of the motor cortex through the scalp. EMG response will be recorded by surface electrodes (Signa lConditioning Electrodes v2.3, Delsys Inc., USA) fixed in quadriceps and tibialis anterior muscles. by the SENIAM protocol (www.seniam.org).
During treatment Motor evoked potential (MEP)
Time frame: During treatment at 5 min.
The action potential elicited by transcranial magnetic stimulation of the motor cortex through the scalp. EMG response will be recorded by surface electrodes (Signa lConditioning Electrodes v2.3, Delsys Inc., USA) fixed in quadriceps and tibialis anterior muscles. by the SENIAM protocol (www.seniam.org).
Post-treatment 1 Motor evoked potential (MEP)
Time frame: At 2 min after treatment.
The action potential elicited by transcranial magnetic stimulation of the motor cortex through the scalp. EMG response will be recorded by surface electrodes (Signa lConditioning Electrodes v2.3, Delsys Inc., USA) fixed in quadriceps and tibialis anterior muscles. by the SENIAM protocol (www.seniam.org).
Post-treatment 2 Motor evoked potential (MEP)
Time frame: At 4 min after treatment.
The action potential elicited by transcranial magnetic stimulation of the motor cortex through the scalp. EMG response will be recorded by surface electrodes (Signa lConditioning Electrodes v2.3, Delsys Inc., USA) fixed in quadriceps and tibialis anterior muscles. by the SENIAM protocol (www.seniam.org).
2 secondary outcomes
Baseline Strength
Time frame: Baseline at 0 min.
Post-treatment Strength
Time frame: At 8 min after treatment.
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 1 May 2020.
- 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.
Julio Gómez-Soriano, PhD principal investigator
Castilla-La Mancha University
3 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 Motor Activity, run by University of Castilla-La Mancha at 3 sites in Spain.
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 1 inclusion and 12 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 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Baseline Motor evoked potential (MEP) (time frame: baseline at 0 min.). The study lists 4 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 1 May 2020.