Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-29 @ 11:44 PM
Study NCT ID:
NCT06294457
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Non-invasive Neuromodulation for Intestinal Transit in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The device will be placed with no current. This type of neuromodulation gives no feeling at all to the patient while administred, so there is no way for the patient to know if the apparatus is connected or not.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2024-02-19', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life by constipation (CVE-20)', 'timeFrame': '10 minutes', 'description': 'Questionnaire. https://www.sciencedirect.com/science/article/abs/pii/S0025775308722851#aep-article-footnote-id'}], 'secondaryOutcomes': [{'measure': 'Sleep Quality', 'timeFrame': '10 minutes', 'description': 'Questionnaire'}, {'measure': 'Cardiac Frecuency', 'timeFrame': '5 minutes', 'description': 'Measured with WeCardio.'}, {'measure': 'Arterial pressure', 'timeFrame': '5 minutes', 'description': 'With Sfigmomanometer'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Constipation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.frontiersin.org/articles/10.3389/fphys.2022.1032020', 'label': 'Citation'}, {'url': 'https://www.cientperiodique.com/article/CPQOS/5/4/97', 'label': 'Citation'}, {'url': 'https://doi.org/10.1016/j.eurpsy.2016.01.578', 'label': 'Citation'}, {'url': 'https://doi.org/10.1016/j.eurpsy.2017.01.1048', 'label': 'Citation'}, {'url': 'https://doi.org/10.1186/s12887-023-04307-4', 'label': 'Citation'}]}, 'descriptionModule': {'briefSummary': 'Objectives\n\nMain objective:\n\nAssess the effectiveness of non-invasive neuromodulation treatment (NESA) for the management of constipation in patients without diagnosed pathology in Spain\n\nSecondary objectives:\n\nEvaluate the improvement in sleep quality Analyze the improvement in blood pressure quality Measure the improvement in cortisol quality Determine if there is an improvement in heart rate', 'detailedDescription': "Background and Current State of the Topic Non-invasive NESA neuromodulation is based on a superficial treatment through electrical microcurrents, regulated by Wilder's law and hormesis.\n\nIt involves applying a low-frequency biphasic current that emits up to 19,000 pulses/minute, with an intensity varying from 0.1 to 1 milliwatt and a frequency from 1 to 15 hertz, generating a weak and physiological electrical signal which is amplified due to its entry through many pathways via electrodes placed on the limbs .\n\nImperceptible sensations are produced in areas of low impedance for individuals. All these parameters fluctuate according to the device's programs. NESA aims to neuromodulate the Autonomic Nervous System (ANS), inducing changes in the endogenous responses of dysfunctional systems or those with pathologies. The ANS is an essential component of the Nervous System responsible for maintaining the organism's homeostasis and responding to internal or external changes through adaptation responses. It consists of the sympathetic and parasympathetic systems, involuntary systems in charge of regulating respiration, circulation, metabolism, digestion, body temperature, reproduction, and glandular secretion.\n\nConstipation is defined as a gastrointestinal motility disorder characterized by difficult or infrequent bowel movements (fewer than three times per week). It is one of the most common gastrointestinal diseases, affecting between 0.7% and 29.6% of the population in developed and developing countries. Constipation can affect overall quality of life. It may trigger sleep disorders, anxiety, depression, and other psychological complications, even increasing mortality associated with conditions such as hypertension, cardiovascular diseases, cerebrovascular diseases, and the incidence of colon cancer.\n\nSince the etiology and mechanism of constipation are complicated, many of the currently available treatments are not effective for many people.\n\nGiven that NESA performs a non-invasive neuromodulation on the ANS through the nerve pathways involved in improving constipation, effects in this regard are expected.\n\nNon-invasive NESA neuromodulation has emerged as a promising area of research with potentially significant results in terms of improving sleep quality and daytime sleepiness, nerve and cognitive function, quality of life, and pain. This study aims to clarify these aspects, establishing a solid foundation for clinical practice and future research.\n\nJustification The ANS is responsible for maintaining the organism's homeostasis and responding to internal or external changes through adaptation responses. The gastrointestinal motility disorder of constipation and the irregular contractions of overactive bladder are conditions in which there are alterations in the ANS, which is why neuromodulation of the ANS can induce changes in the endogenous responses in dysfunctional systems . The chosen population is healthy or not previously diagnosed to assess them for changes in gastrointestinal motility"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants from 18 to 65 years old\n* Sign informed consent\n\nExclusion Criteria:\n\n* Diagnosed diseases at the time of the study.\n* Severe previous psychiatric conditions.\n* Medical contraindications that prevent the use of non-invasive neuromodulation therapy.\n* Having exercised in the hours prior to the NESA treatment.\n* Having consumed coffee or tobacco in the hours prior to the treatment.\n* Minors.\n* Individuals who have previously received any type of neuromodulation treatment.\n* Cancer.'}, 'identificationModule': {'nctId': 'NCT06294457', 'briefTitle': 'Effectiveness of Non-invasive Neuromodulation for Intestinal Transit in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Europea de Madrid'}, 'officialTitle': 'Effectiveness of Non-invasive Neuromodulation Treatment (NESA) for the Management of Constipation Without Diagnosed Pathology in Students of the European University of Madrid (Spain)', 'orgStudyIdInfo': {'id': 'CI-2024-480'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The total number of sessions to be conducted for each patient will be 10 sessions, spread over 5 weeks, which means a frequency of twice a week.\n\nEach NESA microcurrent session will last 60 minutes. A maximum time of 15 minutes will be allowed for connecting the patient at the beginning and for removing the device at the end.\n\nThe directing electrode will be located throughout the treatment between the spinous processes of C6 and C7 to act generally on the individual, and in later sessions, the electrode will be placed d at T12-S3 to influence the sacral plexus.\n\nThe intensity will be set to Low (3 volts) in all sessions,. The other device parameters range between 100-900 microamperes and between 1.14 and 14.29 hertz, and are preset by each program.', 'interventionNames': ['Device: Non-Invasive Neuromodulation NESA']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Non-active Non-Invasive Neuromodulation NESA', 'interventionNames': ['Device: Non-Invasive Neuromodulation NESA']}], 'interventions': [{'name': 'Non-Invasive Neuromodulation NESA', 'type': 'DEVICE', 'description': 'Considering the objectives set: In the first phase, the directing electrode will be located at C6-C7 to generate a systemic and general effect on the organism, with program 1, program 2, program 7, and program 8. In the second phase, the directing electrode will be placed at the abdominal level in the area of the mesenteric plexus to influence the sympathetic innervation of the viscera. In the third phase, the directing electrode is located at S2-S3 to concentrate the action of the therapy on the sacral parasympathetic plexus, responsible for the innervation of the rectum. In this way, both the sympathetic and parasympathetic innervation of the main sexual organs and the large intestine are covered through the sympathetic paravertebral ganglia and the sacral plexus.', 'armGroupLabels': ['Intervention', 'Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Europea de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor', 'investigatorFullName': 'Vanesa Abuín', 'investigatorAffiliation': 'Universidad Europea de Madrid'}}}}