Dose-Efficacy of rTMS in Healthy Young Female Volunteers

NCT07192328 | Completed DMC

• 4 other identifiers: IF04-03/2021PERIS grant (SLT017/20/000125)PERIS grant SLT017/20/000236ICI (ICI20/00117)
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fecal Incontinence (FI); Healthy Female Volunteer

Keywords

Motor Evoked Potentials; Healthy Volunteers; Neuromodulation; Transcranial Magnetic Stimulation; Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

• MEP Latency

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

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

Secondary Outcomes (1)

• MEP amplitude

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

Study Arms (5)

rTMS 1Hz

EXPERIMENTAL

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 5Hz

EXPERIMENTAL

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 1Hz

EXPERIMENTAL

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 5Hz

EXPERIMENTAL

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 10Hz

EXPERIMENTAL

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).

Interventions

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.

Also known as: rTMS, Neurostimulation, Neuromodulation

rTLSMS 10Hz; rTLSMS 1Hz; rTLSMS 5Hz; rTMS 1Hz; rTMS 5Hz

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Mataró: lead

Study Sites (1)

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

Location

Related Publications (3)

• Rao SSC, Yan Y, Xiang X, Sharma A, Ayyala D, Hamdy S. Effects of Translumbosacral Neuromodulation Therapy on Gut and Brain Interactions and Anorectal Neuropathy in Fecal Incontinence: A Randomized Study. Neuromodulation. 2021 Oct;24(7):1269-1277. doi: 10.1111/ner.13485. Epub 2021 Jun 22.

  PMID: 34156730 BACKGROUND

• Tantiphlachiva K, Attaluri A, Valestin J, Yamada T, Rao SS. Translumbar and transsacral motor-evoked potentials: a novel test for spino-anorectal neuropathy in spinal cord injury. Am J Gastroenterol. 2011 May;106(5):907-14. doi: 10.1038/ajg.2010.478. Epub 2011 Jan 25.

  PMID: 21266960 BACKGROUND

• Xiang X, Patcharatrakul T, Sharma A, Parr R, Hamdy S, Rao SSC. Cortico-anorectal, Spino-anorectal, and Cortico-spinal Nerve Conduction and Locus of Neuronal Injury in Patients With Fecal Incontinence. Clin Gastroenterol Hepatol. 2019 May;17(6):1130-1137.e2. doi: 10.1016/j.cgh.2018.09.007. Epub 2018 Sep 10.

  PMID: 30213585 BACKGROUND

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Transcranial Magnetic Stimulation; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Lluís Mundet, RN, PhD

  Hospital de Mataró

  PRINCIPAL INVESTIGATOR

• Pere Clavé, MD, PhD

  Hospital de Mataró

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator GI Motility Unit

Model Details: This was a randomized cross-over dose-response study conducted at the GI Motility Unit, Hospital de Mataró (Barcelona, Spain), in healthy young female volunteers aged 18-35 years. Exclusion criteria included pregnancy or potential for pregnancy, presence of a pacemaker, history of epilepsy or neurosurgery, study withdrawal, and poor treatment tolerance.

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 25, 2025
• Study Start: January 11, 2024
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

ES (1)