Dose-Efficacy of rTMS in Healthy Young Female Volunteers

N/ACompletedNCT07192328

Hospital de Mataró10 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fecal Incontinence (FI)Healthy Female Volunteer

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hospital de Mataró

Mataró, Barcelona, Spain

Outcomes

Primary Outcomes

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).

Secondary Outcomes

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).

Data from ClinicalTrials.gov

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