An interventional study of rTMS and rTLSMS administered using a Magstim Rapid2 repetitive stimulator at pre-identified hotspots (cortical, lumbar, and sacral regions bilaterally). in Fecal Incontinence (FI) and Healthy Female Volunteer, sponsored by Hospital de Mataró. Completed at 1 site in Spain. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by Hospital de Mataró · Not applicable, Interventional, and Treatment
This study is aimed to develop a new therapy based on non-invasive repetitive magnetic stimulation rehabilitation for FI in patients who do not respond to conventional therapies.
AIMS 1) General: to develop a new therapy based on non-invasive repetitive magnetic stimulation rehabilitation for FI in patients who do not respond to conventional therapies. 2) Specific: a) To evaluate the optimal dose of cortical magnetic stimulation (rTMS) and lumbosacral magnetic stimulation (rTLS) in young healthy women for its subsequent application in patients with FI. b) To assess the effect of rTMS and rTLS on continence, clinical severity, and QoL in women with FI.
DESIGN: 1. Cross-over clinical trial dose-efficacy study: Evaluation of the dose-efficacy of acute rTMS and rTLS in 30 healthy young women. Frequencies will be evaluated for cortical rTMS (1Hz and 5Hz) and 3 rTLS (1, 5, and 10Hz).
283 studies on the registry are indexed under Fecal Incontinence; 52 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 203 interventional studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →Hospital de Mataró is the lead sponsor of 27 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
rTMS delivered with 250 pulses via double-cone coil at either 1 Hz
Device: rTMS and rTLSMS administered using a Magstim Rapid2 repetitive stimulator at pre-identified hotspots (cortical, lumbar, and sacral regions bilaterally).
rTMS delivered with 250 pulses via double-cone coil at either 5 Hz
Device: rTMS and rTLSMS administered using a Magstim Rapid2 repetitive stimulator at pre-identified hotspots (cortical, lumbar, and sacral regions bilaterally).
rTLSMS (lumbar and sacral), 2400 pulses (600 per hotspot) applied at 1 Hz, using a 70mm refrigerated air film coil
Device: rTMS and rTLSMS administered using a Magstim Rapid2 repetitive stimulator at pre-identified hotspots (cortical, lumbar, and sacral regions bilaterally).
rTLSMS (lumbar and sacral), 2400 pulses (600 per hotspot) applied at 5 Hz, using a 70mm refrigerated air film coil
Device: rTMS and rTLSMS administered using a Magstim Rapid2 repetitive stimulator at pre-identified hotspots (cortical, lumbar, and sacral regions bilaterally).
rTLSMS (lumbar and sacral), 2400 pulses (600 per hotspot) applied at 10 Hz, using a 70mm refrigerated air film coil
Device: rTMS and rTLSMS administered using a Magstim Rapid2 repetitive stimulator at pre-identified hotspots (cortical, lumbar, and sacral regions bilaterally).
rTMS and rTLSMS administered using a Magstim Rapid2 repetitive stimulator at pre-identified hotspots (cortical, lumbar, and sacral regions bilaterally. rTMS delivered with 250 pulses via the same double-cone coil used for the neurophysiological study, at either 1 Hz or 5 Hz. For rTLSMS (lumbar and sacral), 2400 pulses (600 per hotspot) were applied at 1 Hz, 5 Hz, or 10 Hz using a 70mm refrigerated air film coil (Magstim, UK). Each dose and stimulation site (cortical or peripheral) were tested in separate sessions.
Also known as: rTMS, Neurostimulation, Neuromodulation
MEP Latency
Latency from the onset of the stimuli (cortical or lumbosacral) to the first deflection of the MEP waveform.
Time frame: Baseline (immediately before stimulation) and immediately after stimulation in each session, across 5 weekly sessions (up to 5 weeks).
MEP amplitude
Amplitude measured peak-to-peak of the MEP waveform.
Time frame: Baseline (immediately before stimulation) and immediately after stimulation in each session, across 5 weekly sessions (up to 5 weeks).
Plan to share: Undecided — Sharing individual participant data is a decision we still have not taken
Ran from Jan 2024 to primary completion in Apr 2025, 14 months.
Of 70 non-industry interventional studies with no phase under Fecal Incontinence, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 57. This study's 14 months is below that.
Counting every sponsor, half of 86 studies reached it within 36 months; a quarter within 20 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Hospital de Mataró