Dose-Efficacy of rTMS in Healthy Young Female Volunteers

NCT ID: NCT07192328

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-11

Study Completion Date

2025-06-01

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Fecal Incontinence (FI) Healthy Female Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rTMS 1Hz

rTMS delivered with 250 pulses via double-cone coil at either 1 Hz

Group Type EXPERIMENTAL

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

Intervention Type 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.

rTMS 5Hz

rTMS delivered with 250 pulses via double-cone coil at either 5 Hz

Group Type EXPERIMENTAL

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

Intervention Type 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.

rTLSMS 1Hz

rTLSMS (lumbar and sacral), 2400 pulses (600 per hotspot) applied at 1 Hz, using a 70mm refrigerated air film coil

Group Type EXPERIMENTAL

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

Intervention Type 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.

rTLSMS 5Hz

rTLSMS (lumbar and sacral), 2400 pulses (600 per hotspot) applied at 5 Hz, using a 70mm refrigerated air film coil

Group Type EXPERIMENTAL

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

Intervention Type 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.

rTLSMS 10Hz

rTLSMS (lumbar and sacral), 2400 pulses (600 per hotspot) applied at 10 Hz, using a 70mm refrigerated air film coil

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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rTMS Neurostimulation Neuromodulation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital de Mataró

OTHER

Sponsor Role lead

Responsible Party

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Lluís Mundet

Principal Investigator GI Motility Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lluís Mundet, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Mataró

Pere Clavé, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Mataró

Locations

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Hospital de Mataró

Mataró, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 34156730 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21266960 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30213585 (View on PubMed)

Other Identifiers

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PERIS grant (SLT017/20/000125)

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PERIS grant SLT017/20/000236

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ICI (ICI20/00117)

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IF04-03/2021

Identifier Type: -

Identifier Source: org_study_id

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