Dose-Efficacy of rTMS in Healthy Young Female Volunteers
NCT ID: NCT07192328
Last Updated: 2025-09-25
Study Results
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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COMPLETED
NA
10 participants
INTERVENTIONAL
2024-01-11
2025-06-01
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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rTMS 1Hz
rTMS delivered with 250 pulses via double-cone coil at either 1 Hz
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.
rTMS 5Hz
rTMS delivered with 250 pulses via double-cone coil at either 5 Hz
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.
rTLSMS 1Hz
rTLSMS (lumbar and sacral), 2400 pulses (600 per hotspot) applied at 1 Hz, using a 70mm refrigerated air film coil
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.
rTLSMS 5Hz
rTLSMS (lumbar and sacral), 2400 pulses (600 per hotspot) applied at 5 Hz, using a 70mm refrigerated air film coil
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.
rTLSMS 10Hz
rTLSMS (lumbar and sacral), 2400 pulses (600 per hotspot) applied at 10 Hz, using a 70mm refrigerated air film coil
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be a woman
* capable of understanding and providing informed consent
Exclusion Criteria
* presence of a pacemaker
* history of epilepsy or neurosurgery
* poor treatment tolerance
18 Years
35 Years
FEMALE
Yes
Sponsors
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Hospital de Mataró
OTHER
Responsible Party
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Lluís Mundet
Principal Investigator GI Motility Unit
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
Countries
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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.
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.
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.
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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