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Completed

NCT Number: NCT07192328

Dose-Efficacy of rTMS in Healthy Young Female Volunteers

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.

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Key information

Conditions

Fecal Incontinence (FI) Digestive System Diseases Fecal Incontinence Gastrointestinal Diseases Healthy Female Volunteer Intestinal Diseases Rectal Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • no history of FI
  • Be a woman
  • capable of understanding and providing informed consent

Exclusion criteria

  • pregnancy and the ability to become pregnant
  • presence of a pacemaker
  • history of epilepsy or neurosurgery
  • poor treatment tolerance

Treatment and study plan

rTMS and rTLSMS administered using a Magstim Rapid2 repetitive stimulator at pre-identified hotspots (cortical, lumbar, and sacral regions bilaterally).

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 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.

Other names: rTMS, Neurostimulation, Neuromodulation

Primary outcomes

  1. MEP Latency

    Time frame: Baseline (immediately before stimulation) and immediately after stimulation in each session, across 5 weekly sessions (up to 5 weeks).

    Latency from the onset of the stimuli (cortical or lumbosacral) to the first deflection of the MEP waveform.

Secondary outcomes

  1. MEP amplitude

    Time frame: Baseline (immediately before stimulation) and immediately after stimulation in each session, across 5 weekly sessions (up to 5 weeks).

    Amplitude measured peak-to-peak of the MEP waveform.

Sponsors and collaborators

Lead sponsor

Hospital de Mataró

Other

Registry information

Official study title

Randomized Cross-Over Dose-Efficacy Study of rTMS in Healthy Young Female Volunteers

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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