Dataset Information

A protocol for an interventional study on the impact of transcutaneous parasacral nerve stimulation in children with functional constipation.

ABSTRACT:

Introduction

Transcutaneous parasacral nerve stimulation (TPNS) via electrodes placed over the sacrum can activate afferent neuronal networks noninvasively, leading to sacral reflexes that may improve colonic motility. Thus, TPNS can be considered a promising, noninvasive, and safe method for the treatment of constipation. However, there is no published study investigating its use in children with functional constipation. This is a single-center, prospective, longitudinal, and interventional study designed to assess the applicability and clinical outcomes of TPNS in functionally constipated children.

Patient concerns

Parents or guardians of patients will be informed of the purpose of the study and will sign an informed consent form. The participants may leave the study at any time without any restrictions.

Diagnosis

Twenty-eight children (7-18 years old) who were diagnosed with intestinal constipation (Rome IV criteria) will be included.

Interventions

The patients will be submitted to daily sessions of TPNS for a period of 4 or 8 weeks and will be invited to participate in semistructured interviews at 3 or 4 moments: 1 week before the beginning of TPNS; immediately after the 4 and/or 8 weeks of TPNS; and 4 weeks after the end of the intervention period. In these appointments, the aspects related to bowel habits and quality of life will be assessed.

Outcomes

This study will evaluate the increase in the number of bowel movements and stool consistency, the decrease in the number of episodes of retentive fecal incontinence, and the indirect improvement in the overall quality of life.

Conclusion

we expect that this study protocol can show the efficacy of this promising method to assist the treatment of children with functional constipation.

SUBMITTER: Coelho GM

PROVIDER: S-EPMC7748169 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

A protocol for an interventional study on the impact of transcutaneous parasacral nerve stimulation in children with functional constipation.

Coelho Giovanna Maria GM Machado Nilton Carlos NC Carvalho Mary de Assis MA Rego Rebeca Mayara Padilha RMP Vieira Stefani Rabelo SR Ortolan Erika Veruska Paiva EVP Lourenção Pedro Luiz Toledo de Arruda PLTA

Medicine 20201201 51

<h4>Introduction</h4>Transcutaneous parasacral nerve stimulation (TPNS) via electrodes placed over the sacrum can activate afferent neuronal networks noninvasively, leading to sacral reflexes that may improve colonic motility. Thus, TPNS can be considered a promising, noninvasive, and safe method for the treatment of constipation. However, there is no published study investigating its use in children with functional constipation. This is a single-center, prospective, longitudinal, and interventi ...[more]

PMID: 33371132

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Project description:BackgroundOver 55 million adults are living with dementia globally, which is projected to reach 157 million by 2050. Mild cognitive impairment (MCI), a syndrome of memory impairment with intact activities of daily living, may precede dementia by several years. Around 5-15% of individuals with MCI convert to dementia annually. Novel treatments which delay progression of MCI to dementia are urgently needed. Transcutaneous vagal nerve stimulation (tVNS) is a non-invasive neuromodulation technique that targets the vagus nerve. Importantly, tVNS has been shown to improve cognition in healthy volunteers, but has not been extensively examined as a potential therapeutic approach in MCI. VINCI-AD will examine the safety and feasibility of tVNS in older adults with MCI.DesignVINCI-AD is an investigator-led, single-site, single-blind, sham-controlled crossover pilot study which aims to assess the safety and feasibility of tVNS in 40 participants with amnestic MCI. All participants will attend for three consecutive study visits during which they will be randomised to receive no stimulation (baseline), active tVNS stimulation (stimulation at cymba conchae of left ear) or sham tVNS stimulation (at earlobe). Safety will be primarily assessed by ascertainment of adverse events. Further safety assessment will examine the impact of acute tVNS on subjective (orthostatic symptoms), peripheral (finometry-based blood pressure) and central (assessed via Near Infrared Spectroscopy [NIRS]) haemodynamic responses to active stand. Feasibility will be determined using a custom-designed occupational assessment of device usability. Exploratory secondary analysis in VINCI-AD will examine the potential impact of acute tVNS on associative memory, spatial memory and inhibitory control to inform sample size estimates for future trials of tVNS in older adults with MCI.DiscussionVINCI-AD will report on the safety (adverse events/haemodynamic responses to active stand) and feasibility of tVNS as a potential therapeutic option in MCI. Detailed reporting of study eligibility and completion rates will be reported. Exploratory analysis will examine the potential cognitive benefits of acute tVNS on cognitive function in MCI to report potential effect sizes that may inform future clinical trials in this cohort.Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT05514756 . Trial Registration Number NCT05514756 (24th August 2022 for this protocol, version 1.0.).

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Dataset Information

A protocol for an interventional study on the impact of transcutaneous parasacral nerve stimulation in children with functional constipation.

Introduction

Patient concerns

Diagnosis

Interventions

Outcomes

Conclusion

Publications

A protocol for an interventional study on the impact of transcutaneous parasacral nerve stimulation in children with functional constipation.

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