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| ID | Type | Description | Link |
|---|---|---|---|
| PERIS grant (SLT017/20/000125) | Other Grant/Funding Number | Departament de Salut de la Generalitat de Catalunya | |
| PERIS grant SLT017/20/000236 | Other Grant/Funding Number | Departament de Salut de la Generalitat de Catalunya | |
| ICI (ICI20/00117) | Other Grant/Funding Number | Instituto de Salud Carlos III, Barcelona, Spain |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS 1Hz | Experimental | rTMS delivered with 250 pulses via double-cone coil at either 1 Hz |
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| rTMS 5Hz | Experimental | rTMS delivered with 250 pulses via double-cone coil at either 5 Hz |
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| rTLSMS 1Hz | Experimental | rTLSMS (lumbar and sacral), 2400 pulses (600 per hotspot) applied at 1 Hz, using a 70mm refrigerated air film coil |
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| rTLSMS 5Hz | Experimental | rTLSMS (lumbar and sacral), 2400 pulses (600 per hotspot) applied at 5 Hz, using a 70mm refrigerated air film coil |
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| rTLSMS 10Hz | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| MEP amplitude | Amplitude measured peak-to-peak of the MEP waveform. | Baseline (immediately before stimulation) and immediately after stimulation in each session, across 5 weekly sessions (up to 5 weeks). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lluís Mundet, RN, PhD | Hospital de Mataró | Principal Investigator |
| Pere Clavé, MD, PhD | Hospital de Mataró | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Mataró | Mataró | Barcelona | 08304 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34156730 | Background | 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. | |
| 21266960 | Background |
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Sharing individual participant data is a decision we still have not taken
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
| D004599 | Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
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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.
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rTLSMS (lumbar and sacral), 2400 pulses (600 per hotspot) applied at 10 Hz, using a 70mm refrigerated air film coil
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| 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. |
| 30213585 | Result | 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. |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |