Dose-Efficacy of rTMS in Healthy Young Female Volunteers

Hospital de Mataró

Status: Completed

Conditions: Healthy Female Volunteer; Fecal Incontinence (FI)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07192328

IF04-03/2021

PERIS grant (SLT017/20/000125) (Other Grant/Funding Number)

PERIS grant SLT017/20/000236 (Other Grant/Funding Number)

ICI (ICI20/00117) (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 10 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 5 patient groups

rTMS 1Hz

Experimental group

Description:

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

Treatment:

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

rTMS 5Hz

Experimental group

Description:

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

Treatment:

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

rTLSMS 1Hz

Experimental group

Description:

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

Treatment:

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

rTLSMS 5Hz

Experimental group

Description:

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

Treatment:

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

rTLSMS 10Hz

Experimental group

Description:

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

Treatment:

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