Healthy IndividualsPhase 1NCT07026760
Effects of Trans-spinal Magnetic Stimulation on Cortical Excitability in Healthy Individuals
A Phase 1 study testing Trans-spinal magnetic stimulation (90% MT + 1 Hz), Trans-spinal magnetic stimulation (100% MT + 1 Hz) and Trans-spinal magnetic stimulation (110% MT + 1 Hz) in people with Healthy Individuals, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
This study investigates the immediate effects of different parameters (frequency and intensity) of trans-spinal magnetic stimulation (TsMS) on cortical excitability in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- Trans-spinal magnetic stimulation (90% MT + 1 Hz), Trans-spinal magnetic stimulation (100% MT + 1 Hz) and Trans-spinal magnetic stimulation (110% MT + 1 Hz)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2022to 30 Oct 2025
- Phase
- Phase 1
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Pregnancy; history of seizures or epilepsy; metallic implants in the head, spine, face, or heart; diagnosed neurological or musculoskeletal conditions that could interfere with assessments or interventions; or use of substances that alter nervous system excitability.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Pernambuco
Recife, Pernambuco, 50740-560
João Fabrício, +55 81 986450112, joaovmelo2015@gmail.com
About this study
This study investigates the immediate effects of different parameters (frequency and intensity) of trans-spinal magnetic stimulation (TsMS) on cortical excitability in healthy individuals. Using a randomized, double-blind crossover design, the research aims to identify optimal stimulation protocols for modulating neural activity. Outcomes include measurements of motor-evoked potentials (MEP), intracortical inhibition (ICI), and facilitation (ICF). Findings may enhance non-invasive therapeutic strategies for neurological disorders.
Read the detailed description
This clinical trial comprises one arm: it evaluates trans-spinal magnetic stimulation (TsMS) applied at the C7 vertebral level, testing three frequencies (1 Hz, 10 Hz, and 25 Hz) and three intensities (90%, 100%, and 110% of the resting motor threshold) across sequential phases.
Methods: The study is a crossover, double-blind trial in which healthy adults (aged 18-40 years) undergo pre- and post-intervention assessments of cortical excitability (MEP, ICI, and ICF). Statistical analyses will be performed using ANOVA or Friedman tests (SPSS v.26).
The results will clarify whether the neuromodulatory effects of the stimulation are parameter-dependent and will guide future rehabilitation protocols for neurological conditions.
The research was approved by the Ethics Committee of the Federal University of Pernambuco (Resolution 466/12). All data will be stored securely for the next five years.
- Conditions
- Healthy Individuals
- Being tested
- Trans-spinal magnetic stimulation (90% MT + 1 Hz), Trans-spinal magnetic stimulation (100% MT + 1 Hz), Trans-spinal magnetic stimulation (110% MT + 1 Hz), Trans-spinal magnetic stimulation (90% + 10 Hz), Trans-spinal magnetic stimulation (100% MT + 10 Hz)
- Keywords
- Trans-spinal magnetic stimulation, Cortical Excitability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-spinal magnetic stimulation (90% MT + 1 Hz)Device
Low frequency stimulation (1 Hz) at 90% of resting motor threshold intensity, delivering a total of 2400 pulses.
Trans-spinal magnetic stimulation (100% MT + 1 Hz)Device
Low frequency stimulation (1 Hz) at 100% of resting motor threshold intensity, delivering a total of 2400 pulses.
Trans-spinal magnetic stimulation (110% MT + 1 Hz)Device
Low frequency stimulation (1 Hz) at 110% of resting motor threshold intensity, delivering a total of 2400 pulses.
Trans-spinal magnetic stimulation (90% + 10 Hz)Device
High frequency stimulation (10 Hz) at 90% of resting motor threshold intensity, delivering a total of 2400 pulses.
Trans-spinal magnetic stimulation (100% MT + 10 Hz)Device
High frequency stimulation (10 Hz) at 100% of resting motor threshold intensity, delivering a total of 2400 pulses.
Trans-spinal magnetic stimulation (110% MT + 10 Hz)Device
High frequency stimulation (10 Hz) at 110% of resting motor threshold intensity, delivering a total of 2400 pulses.
Trans-spinal magnetic stimulation (90% MT + 25 Hz)Device
High frequency stimulation (25 Hz) at 90% of resting motor threshold intensity, delivering a total of 2400 pulses.
Trans-spinal magnetic stimulation (100% MT + 25 Hz)Device
High frequency stimulation (25 Hz) at 100% of resting motor threshold intensity, delivering a total of 2400 pulses.
Trans-spinal magnetic stimulation (110% MT + 25 Hz)Device
High frequency stimulation (25 Hz) at 110% of resting motor threshold intensity, delivering a total of 2400 pulses.
| Study group | Role | What they receive |
|---|---|---|
| Trans-spinal magnetic stimulation (1 Hz + 90% MT) | Active comparator | Not described Receives: Device: Trans-spinal magnetic stimulation (90% MT + 1 Hz) |
| Trans-spinal magnetic stimulation (1 Hz + 100% MT) | Active comparator | Not described Receives: Device: Trans-spinal magnetic stimulation (100% MT + 1 Hz) |
| Trans-spinal magnetic stimulation (1 Hz + 110% MT) | Active comparator | Not described Receives: Device: Trans-spinal magnetic stimulation (110% MT + 1 Hz) |
| Trans-spinal magnetic stimulation (10 Hz + 90% MT) | Active comparator | Not described Receives: Device: Trans-spinal magnetic stimulation (90% + 10 Hz) |
| Trans-spinal magnetic stimulation (10 Hz + 100% MT) | Active comparator | Not described Receives: Device: Trans-spinal magnetic stimulation (100% MT + 10 Hz) |
| Trans-spinal magnetic stimulation (10 Hz + 110% MT) | Active comparator | Not described Receives: Device: Trans-spinal magnetic stimulation (110% MT + 10 Hz) |
| Trans-spinal magnetic stimulation (25 Hz + 90% MT) | Active comparator | Not described Receives: Device: Trans-spinal magnetic stimulation (90% MT + 25 Hz) |
| Trans-spinal magnetic stimulation (25 Hz + 100% MT) | Active comparator | Not described Receives: Device: Trans-spinal magnetic stimulation (100% MT + 25 Hz) |
| Trans-spinal magnetic stimulation (25 Hz + 110% MT) | Active comparator | Not described Receives: Device: Trans-spinal magnetic stimulation (110% MT + 25 Hz) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical excitability
Cortical excitability will be assessed using motor-evoked potentials (MEPs) elicited by single-pulse transcranial magnetic stimulation (TMS) over the primary motor cortex (M1), specifically targeting the cortical representation of the first dorsal interosseous (FDI) muscle. The stimulation hotspot will be defined as the scalp location that elicits the largest and most consistent MEP amplitude at the lowest stimulation intensity. Single-pulse TMS will be delivered at 100% of the resting motor threshold (RMT). Paired-pulse TMS protocols will be used to evaluate intracortical inhibition (ICI) and intracortical facilitation (ICF), using a subthreshold conditioning stimulus set at 80% of RMT and a suprathreshold test stimulus set at 120% of RMT, with interstimulus intervals of 3 ms for ICI and 10 ms for ICF. MEP amplitudes will be recorded from the FDI muscle using bipolar surface electromyography (EMG). Signals will be digitized at 20,000 Hz (bandpass 5-10,000 Hz) for offlin
Measured: Baseline (T0), immediately post-stimulation (T1), and at 15 (T2) and 30 minutes (T3) after stimulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start1 Oct 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kátia Monte-Silva, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026760
- Sponsor's protocol ID
- 58678222.8.0000.5208
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 18 Jun 2025
- 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 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Trans-spinal Magnetic Stimulation on Cortical Excitability in Healthy Individuals
- ClinicalTrials.gov ID
- NCT07026760
- Acronym / sponsor ID
- 58678222.8.0000.5208
- Conditions
- Healthy Individuals
- Keywords
- Trans-spinal magnetic stimulation, Cortical Excitability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 18 Jun 2025 (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.
This study investigates the immediate effects of different parameters (frequency and intensity) of trans-spinal magnetic stimulation (TsMS) on cortical excitability in healthy individuals. Using a randomized, double-blind crossover design, the research aims to identify optimal stimulation protocols for modulating neural activity. Outcomes include measurements of motor-evoked potentials (MEP), intracortical inhibition (ICI), and facilitation (ICF). Findings may enhance non-invasive therapeutic strategies for neurological disorders.
Detailed description
This clinical trial comprises one arm: it evaluates trans-spinal magnetic stimulation (TsMS) applied at the C7 vertebral level, testing three frequencies (1 Hz, 10 Hz, and 25 Hz) and three intensities (90%, 100%, and 110% of the resting motor threshold) across sequential phases.
Methods: The study is a crossover, double-blind trial in which healthy adults (aged 18-40 years) undergo pre- and post-intervention assessments of cortical excitability (MEP, ICI, and ICF). Statistical analyses will be performed using ANOVA or Friedman tests (SPSS v.26).
The results will clarify whether the neuromodulatory effects of the stimulation are parameter-dependent and will guide future rehabilitation protocols for neurological conditions.
The research was approved by the Ethics Committee of the Federal University of Pernambuco (Resolution 466/12). All data will be stored securely for the next five years.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Trans-spinal magnetic stimulation (1 Hz + 90% MT) | Active comparator | Device: Trans-spinal magnetic stimulation (90% MT + 1 Hz) |
| Trans-spinal magnetic stimulation (1 Hz + 100% MT) | Active comparator | Device: Trans-spinal magnetic stimulation (100% MT + 1 Hz) |
| Trans-spinal magnetic stimulation (1 Hz + 110% MT) | Active comparator | Device: Trans-spinal magnetic stimulation (110% MT + 1 Hz) |
| Trans-spinal magnetic stimulation (10 Hz + 90% MT) | Active comparator | Device: Trans-spinal magnetic stimulation (90% + 10 Hz) |
| Trans-spinal magnetic stimulation (10 Hz + 100% MT) | Active comparator | Device: Trans-spinal magnetic stimulation (100% MT + 10 Hz) |
| Trans-spinal magnetic stimulation (10 Hz + 110% MT) | Active comparator | Device: Trans-spinal magnetic stimulation (110% MT + 10 Hz) |
| Trans-spinal magnetic stimulation (25 Hz + 90% MT) | Active comparator | Device: Trans-spinal magnetic stimulation (90% MT + 25 Hz) |
| Trans-spinal magnetic stimulation (25 Hz + 100% MT) | Active comparator | Device: Trans-spinal magnetic stimulation (100% MT + 25 Hz) |
| Trans-spinal magnetic stimulation (25 Hz + 110% MT) | Active comparator | Device: Trans-spinal magnetic stimulation (110% MT + 25 Hz) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Pregnancy; history of seizures or epilepsy; metallic implants in the head, spine, face, or heart; diagnosed neurological or musculoskeletal conditions that could interfere with assessments or interventions; or use of substances that alter nervous system excitability.
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 |
|---|---|---|
| Trans-spinal magnetic stimulation (90% MT + 1 Hz)Low frequency stimulation (1 Hz) at 90% of resting motor threshold intensity, delivering a total of 2400 pulses. | Device | Trans-spinal magnetic stimulation (1 Hz + 90% MT) |
| Trans-spinal magnetic stimulation (100% MT + 1 Hz)Low frequency stimulation (1 Hz) at 100% of resting motor threshold intensity, delivering a total of 2400 pulses. | Device | Trans-spinal magnetic stimulation (1 Hz + 100% MT) |
| Trans-spinal magnetic stimulation (110% MT + 1 Hz)Low frequency stimulation (1 Hz) at 110% of resting motor threshold intensity, delivering a total of 2400 pulses. | Device | Trans-spinal magnetic stimulation (1 Hz + 110% MT) |
| Trans-spinal magnetic stimulation (90% + 10 Hz)High frequency stimulation (10 Hz) at 90% of resting motor threshold intensity, delivering a total of 2400 pulses. | Device | Trans-spinal magnetic stimulation (10 Hz + 90% MT) |
| Trans-spinal magnetic stimulation (100% MT + 10 Hz)High frequency stimulation (10 Hz) at 100% of resting motor threshold intensity, delivering a total of 2400 pulses. | Device | Trans-spinal magnetic stimulation (10 Hz + 100% MT) |
| Trans-spinal magnetic stimulation (110% MT + 10 Hz)High frequency stimulation (10 Hz) at 110% of resting motor threshold intensity, delivering a total of 2400 pulses. | Device | Trans-spinal magnetic stimulation (10 Hz + 110% MT) |
| Trans-spinal magnetic stimulation (90% MT + 25 Hz)High frequency stimulation (25 Hz) at 90% of resting motor threshold intensity, delivering a total of 2400 pulses. | Device | Trans-spinal magnetic stimulation (25 Hz + 90% MT) |
| Trans-spinal magnetic stimulation (100% MT + 25 Hz)High frequency stimulation (25 Hz) at 100% of resting motor threshold intensity, delivering a total of 2400 pulses. | Device | Trans-spinal magnetic stimulation (25 Hz + 100% MT) |
| Trans-spinal magnetic stimulation (110% MT + 25 Hz)High frequency stimulation (25 Hz) at 110% of resting motor threshold intensity, delivering a total of 2400 pulses. | Device | Trans-spinal magnetic stimulation (25 Hz + 110% MT) |
Primary outcome
Cortical excitability
Time frame: Baseline (T0), immediately post-stimulation (T1), and at 15 (T2) and 30 minutes (T3) after stimulation.
Cortical excitability will be assessed using motor-evoked potentials (MEPs) elicited by single-pulse transcranial magnetic stimulation (TMS) over the primary motor cortex (M1), specifically targeting the cortical representation of the first dorsal interosseous (FDI) muscle. The stimulation hotspot will be defined as the scalp location that elicits the largest and most consistent MEP amplitude at the lowest stimulation intensity. Single-pulse TMS will be delivered at 100% of the resting motor threshold (RMT). Paired-pulse TMS protocols will be used to evaluate intracortical inhibition (ICI) and intracortical facilitation (ICF), using a subthreshold conditioning stimulus set at 80% of RMT and a suprathreshold test stimulus set at 120% of RMT, with interstimulus intervals of 3 ms for ICI and 10 ms for ICF. MEP amplitudes will be recorded from the FDI muscle using bipolar surface electromyography (EMG). Signals will be digitized at 20,000 Hz (bandpass 5-10,000 Hz) for offlin
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 18 Jun 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trans-spinal magnetic stimulation (90% MT + 1 Hz), Trans-spinal magnetic stimulation (100% MT + 1 Hz) and Trans-spinal magnetic stimulation (110% MT + 1 Hz) in people with Healthy Individuals, run by Universidade Federal de Pernambuco at 1 site in Brazil.
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 0 inclusion and 1 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 18 Jun 2025. 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 Brazil. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kátia Monte-Silva (+55 81 21267579, lana.ufpe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical excitability (time frame: Baseline (T0), immediately post-stimulation (T1), and at 15 (T2) and 30 minutes (T3) after stimulation.). 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 18 Jun 2025.