Effectiveness of Non-invasive Neuromodulation for Intestinal Transit in Healthy Subjects

NCT06294457 | Not Yet Recruiting DMC

• 1 other identifier: CI-2024-480
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectives Main objective: Assess the effectiveness of non-invasive neuromodulation treatment (NESA) for the management of constipation in patients without diagnosed pathology in Spain Secondary objectives: Evaluate 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

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Quality of life by constipation (CVE-20)

  Questionnaire. https://www.sciencedirect.com/science/article/abs/pii/S0025775308722851#aep-article-footnote-id

  10 minutes

Secondary Outcomes (3)

• Sleep Quality

  10 minutes

• Cardiac Frecuency

  5 minutes

• Arterial pressure

  5 minutes

Study Arms (2)

Intervention

EXPERIMENTAL

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. Each 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. The 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. The 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.

Device: Non-Invasive Neuromodulation NESA

Placebo

PLACEBO COMPARATOR

Non-active Non-Invasive Neuromodulation NESA

Device: Non-Invasive Neuromodulation NESA

Interventions

Non-Invasive Neuromodulation NESA DEVICE

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.

Intervention; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants from 18 to 65 years old
• Sign informed consent

You may not qualify if:

• Diagnosed diseases at the time of the study.
• Severe previous psychiatric conditions.
• Medical contraindications that prevent the use of non-invasive neuromodulation therapy.
• Having exercised in the hours prior to the NESA treatment.
• Having consumed coffee or tobacco in the hours prior to the treatment.
• Minors.
• Individuals who have previously received any type of neuromodulation treatment.
• Cancer.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Related Links

• Citation
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MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 5, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share