Healthy VolunteersNCT07719179
Eco-guided Neuromodulation of the Femoral Nerve on the Performance of Amateur Athletes.
A study testing Theta Burst Protocol, 10-10-10 Protocol and 5-55 Protocol in people with Healthy Volunteers and Neuromuscular Function, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
This randomized crossover study aims to evaluate whether different percutaneous electrical nerve stimulation (PENS) protocols produce changes in neuromuscular performance in healthy adults. PENS involves the ultrasound-guided application of an electrical current through a needle to modulate motor neuron excitability. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Neuromuscular Function
- What is being tested?
- Theta Burst Protocol, 10-10-10 Protocol and 5-55 Protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2026to 30 Sep 2026
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Athletes aged between 18 and 30 years.
- Familiarized with performing barbell back squats using an Olympic bar.
- Engaged in regular training at least three times per week during the last six months.
- Able to perform squat and jump tests safely.
- Provided written informed consent to participate in the study.
Who cannot join
- Sports injury within the last two months or current inability to perform physical activity.
- Inability to understand or follow the instructions provided by the therapist.
- Participation in another research study during the same period.
- Belonephobia (fear of needles).
- Ongoing medical or pharmacological treatment that could interfere with neuromuscular performance (e.g., anticonvulsants, antidepressants, or similar medications).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Jacobo Rodríguez Sanz, PhD, +34 636 136 789, jrodriguezs@uic.es
About this study
Official title: Effectiveness of Eco-guided Neuromodulation of the Femoral Nerve on the Performance of Amateur Athletes. Randomized Controlled Crossover Clinical Trial
This randomized crossover study aims to evaluate whether different percutaneous electrical nerve stimulation (PENS) protocols produce changes in neuromuscular performance in healthy adults. PENS involves the ultrasound-guided application of an electrical current through a needle to modulate motor neuron excitability. Each participant will undergo five intervention sessions: (1) a long-term potentiation (LTP)-based protocol with impulse trains, (2) a 10 Hz protocol with 10 s stimulation and 10 s rest repeated ten times, (3) a 5-55 protocol with 100 Hz stimulation for 5 s followed by 55 s rest repeated five times, (4) a high-intensity burst (HIB) protocol applied at a high current intensity close to 1000 mA and repeated three times, and (5) a placebo condition. All interventions will be applied bilaterally by an experienced physiotherapist under ultrasound guidance, with a two-week washout between sessions. The objective of this trial is to assess whether these stimulation patterns produce measurable changes in squat execution velocity, jump performance, and quadriceps strength. The findings may help identify the most effective stimulation strategy for enhancing neuromuscular performance.
- Conditions
- Healthy Volunteers, Neuromuscular Function
- Being tested
- Theta Burst Protocol, 10-10-10 Protocol, 5-55 Protocol, Placebo, High-Intensity Burst (HIB) Protocol
- Keywords
- Neuromuscular Performance, Muscle Strength, Quadriceps, Percutaneous Electrical Nerve Stimulation, Sports Performance, Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theta Burst ProtocolDevice
Also called Impulse Train Protocol
The intervention consists of the bilateral, ultrasound-guided insertion of a needle for percutaneous electrical nerve stimulation (PENS), following a theta-burst pattern designed to produce long-term potentiation-like effects. An asymmetric biphasic compensated current with a rectangular positive phase and a triangular negative phase is applied at a frequency of 100 Hz for 5 seconds, followed by 55 seconds of rest, repeated five times. The pulse width is 240 µs, and the intensity is maintained above the motor threshold and below the pain threshold.
10-10-10 ProtocolDevice
Percutaneous electrical nerve stimulation (PENS) applied under ultrasound guidance at 10 Hz, consisting of 10 seconds of stimulation followed by 10 seconds of rest, repeated ten times. The current intensity is adjusted to produce visible muscle contraction without pain.
5-55 ProtocolDevice
Percutaneous electrical nerve stimulation (PENS) applied under ultrasound guidance at 100 Hz for 5 seconds, followed by 55 seconds of rest, repeated five times. The current intensity is adjusted to elicit a mild tingling sensation while remaining below the pain threshold.
PlaceboDevice
A sham PENS procedure involving ultrasound-guided needle insertion at the same anatomical site without electrical stimulation. The device is manipulated to simulate treatment, but no current is delivered. Participants are informed they might not feel any sensation during the session.
High-Intensity Burst (HIB) ProtocolDevice
Also called High Intensity Burst, HIB
Percutaneous electrical nerve stimulation (PENS) applied under ultrasound guidance using high-intensity bursts delivered bilaterally at a current intensity close to 1000 mA, repeated three times. The stimulation intensity is individually adjusted to approach but not exceed the participant's tolerance threshold.
| Study group | Role | What they receive |
|---|---|---|
| Theta Burst Protocol | Experimental | The intervention consists of the bilateral, ultrasound-guided insertion of a needle for percutaneous electrical nerve stimulation (PENS), following a theta-burst pattern designed to produce long-term potentiation-like effects. An asymmetric biphasic compensated current with a rectangular positive phase and a triangular negative phase is applied at a frequency of 100 Hz for 5 seconds, followed by 55 seconds of rest, repeated five times. The pulse width is 240 µs, and the intensity is maintained above the motor threshold and below the pain threshold. Receives: Device: Theta Burst Protocol |
| 10-10-10 Protocol | Experimental | The intervention consists of the bilateral, ultrasound-guided insertion of a needle for percutaneous electrical nerve stimulation (PENS). An asymmetric biphasic compensated current is applied, with a rectangular positive phase and a triangular negative phase, at a frequency of 10 Hz, pulse width of 240 µs, and an intensity above the motor threshold and below the pain threshold. Each stimulation period lasts 10 seconds, followed by 10 seconds of rest, repeated ten times. Receives: Device: 10-10-10 Protocol |
| 5-55 Protocol | Experimental | Ultrasound-guided PENS protocol applying a 100 Hz stimulation for 5 s followed by 55 s of rest, repeated five times. The intensity is adjusted to a tolerable tingling sensation, below the pain threshold. Receives: Device: 5-55 Protocol |
| HIB Protocol (High-Intensity Burst) | Experimental | Ultrasound-guided PENS protocol consisting of high-intensity bursts applied bilaterally at a current intensity close to 1000 mA, repeated three times. The intensity is set individually, approaching but not exceeding the participant's tolerance threshold. Receives: Device: High-Intensity Burst (HIB) Protocol |
| Placebo | Sham comparator | Ultrasound-guided needle insertion at the same anatomical location without electrical stimulation. The device is manipulated to simulate treatment, but no current is delivered. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in squat execution velocity (m/s) measured with a linear encoder
Measured: pre-intervention, immediately after the intervention
Secondary outcomes (3)
Changes in vertical jump performance (jump height) measured with the MyJump2 app.
Measured: pre-intervention, immediately after the intervention
Changes in quadriceps strength measured in newtons using a force gauge
Measured: pre-intervention, immediately after the intervention
Changes in muscle activation in microvolts (μV) measured via surface electromyography
Measured: pre-intervention, immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacobo Rodríguez Sanz, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719179
- Sponsor's protocol ID
- CBAS-2023-19
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Eco-guided Neuromodulation of the Femoral Nerve on the Performance of Amateur Athletes. Randomized Controlled Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT07719179
- Acronym / sponsor ID
- CBAS-2023-19
- Conditions
- Healthy Volunteers, Neuromuscular Function
- Keywords
- Neuromuscular Performance, Muscle Strength, Quadriceps, Percutaneous Electrical Nerve Stimulation, Sports Performance, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 22 Jul 2026 (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 randomized crossover study aims to evaluate whether different percutaneous electrical nerve stimulation (PENS) protocols produce changes in neuromuscular performance in healthy adults. PENS involves the ultrasound-guided application of an electrical current through a needle to modulate motor neuron excitability. Each participant will undergo five intervention sessions: (1) a long-term potentiation (LTP)-based protocol with impulse trains, (2) a 10 Hz protocol with 10 s stimulation and 10 s rest repeated ten times, (3) a 5-55 protocol with 100 Hz stimulation for 5 s followed by 55 s rest repeated five times, (4) a high-intensity burst (HIB) protocol applied at a high current intensity close to 1000 mA and repeated three times, and (5) a placebo condition. All interventions will be applied bilaterally by an experienced physiotherapist under ultrasound guidance, with a two-week washout between sessions. The objective of this trial is to assess whether these stimulation patterns produce measurable changes in squat execution velocity, jump performance, and quadriceps strength. The findings may help identify the most effective stimulation strategy for enhancing neuromuscular performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Theta Burst Protocol | Experimental | Device: Theta Burst ProtocolThe intervention consists of the bilateral, ultrasound-guided insertion of a needle for percutaneous electrical nerve stimulation (PENS), following a theta-burst pattern designed to produce long-term potentiation-like effects. An asymmetric biphasic compensated current with a rectangular positive phase and a triangular negative phase is applied at a frequency of 100 Hz for 5 seconds, followed by 55 seconds of rest, repeated five times. The pulse width is 240 µs, and the intensity is maintained above the motor threshold and below the pain threshold. |
| 10-10-10 Protocol | Experimental | Device: 10-10-10 ProtocolThe intervention consists of the bilateral, ultrasound-guided insertion of a needle for percutaneous electrical nerve stimulation (PENS). An asymmetric biphasic compensated current is applied, with a rectangular positive phase and a triangular negative phase, at a frequency of 10 Hz, pulse width of 240 µs, and an intensity above the motor threshold and below the pain threshold. Each stimulation period lasts 10 seconds, followed by 10 seconds of rest, repeated ten times. |
| 5-55 Protocol | Experimental | Device: 5-55 ProtocolUltrasound-guided PENS protocol applying a 100 Hz stimulation for 5 s followed by 55 s of rest, repeated five times. The intensity is adjusted to a tolerable tingling sensation, below the pain threshold. |
| HIB Protocol (High-Intensity Burst) | Experimental | Device: High-Intensity Burst (HIB) ProtocolUltrasound-guided PENS protocol consisting of high-intensity bursts applied bilaterally at a current intensity close to 1000 mA, repeated three times. The intensity is set individually, approaching but not exceeding the participant's tolerance threshold. |
| Placebo | Sham comparator | Device: PlaceboUltrasound-guided needle insertion at the same anatomical location without electrical stimulation. The device is manipulated to simulate treatment, but no current is delivered. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Athletes aged between 18 and 30 years.
- Familiarized with performing barbell back squats using an Olympic bar.
- Engaged in regular training at least three times per week during the last six months.
- Able to perform squat and jump tests safely.
- Provided written informed consent to participate in the study.
Key exclusion criteria (5 listed)
- Sports injury within the last two months or current inability to perform physical activity.
- Inability to understand or follow the instructions provided by the therapist.
- Participation in another research study during the same period.
- Belonephobia (fear of needles).
- Ongoing medical or pharmacological treatment that could interfere with neuromuscular performance (e.g., anticonvulsants, antidepressants, or similar medications).
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 |
|---|---|---|
| Theta Burst ProtocolAlso: Impulse Train ProtocolThe intervention consists of the bilateral, ultrasound-guided insertion of a needle for percutaneous electrical nerve stimulation (PENS), following a theta-burst pattern designed to produce long-term potentiation-like effects. An asymmetric biphasic compensated current with a rectangular positive phase and a triangular negative phase is applied at a frequency of 100 Hz for 5 seconds, followed by 55 seconds of rest, repeated five times. The pulse width is 240 µs, and the intensity is maintained above the motor threshold and below the pain threshold. | Device | Theta Burst Protocol |
| 10-10-10 ProtocolPercutaneous electrical nerve stimulation (PENS) applied under ultrasound guidance at 10 Hz, consisting of 10 seconds of stimulation followed by 10 seconds of rest, repeated ten times. The current intensity is adjusted to produce visible muscle contraction without pain. | Device | 10-10-10 Protocol |
| 5-55 ProtocolPercutaneous electrical nerve stimulation (PENS) applied under ultrasound guidance at 100 Hz for 5 seconds, followed by 55 seconds of rest, repeated five times. The current intensity is adjusted to elicit a mild tingling sensation while remaining below the pain threshold. | Device | 5-55 Protocol |
| PlaceboA sham PENS procedure involving ultrasound-guided needle insertion at the same anatomical site without electrical stimulation. The device is manipulated to simulate treatment, but no current is delivered. Participants are informed they might not feel any sensation during the session. | Device | Placebo |
| High-Intensity Burst (HIB) ProtocolAlso: High Intensity Burst, HIBPercutaneous electrical nerve stimulation (PENS) applied under ultrasound guidance using high-intensity bursts delivered bilaterally at a current intensity close to 1000 mA, repeated three times. The stimulation intensity is individually adjusted to approach but not exceed the participant's tolerance threshold. | Device | HIB Protocol (High-Intensity Burst) |
Primary outcome
Changes in squat execution velocity (m/s) measured with a linear encoder
Time frame: pre-intervention, immediately after the intervention
3 secondary outcomes
Changes in vertical jump performance (jump height) measured with the MyJump2 app.
Time frame: pre-intervention, immediately after the intervention
Changes in quadriceps strength measured in newtons using a force gauge
Time frame: pre-intervention, immediately after the intervention
Changes in muscle activation in microvolts (μV) measured via surface electromyography
Time frame: pre-intervention, immediately after the intervention
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 22 Jul 2026.
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Screening Protocol
Pain
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 study testing Theta Burst Protocol, 10-10-10 Protocol and 5-55 Protocol in people with Healthy Volunteers and Neuromuscular Function, run by Universitat Internacional de Catalunya at 1 site 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 5 inclusion and 5 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 22 Jul 2026. 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 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. Some participants in this study may receive a placebo. 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 Jacobo Rodríguez Sanz, PhD (+34 636-136-789, jrodriguezs@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in squat execution velocity (m/s) measured with a linear encoder (time frame: pre-intervention, immediately after the 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 22 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.