ConstipationNCT06294457
Effectiveness of Non-invasive Neuromodulation for Intestinal Transit in Healthy Subjects
A study testing Non-Invasive Neuromodulation NESA in people with Constipation, run by Universidad Europea de Madrid.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Non-Invasive Neuromodulation NESA
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants from 18 to 65 years old
- Sign informed consent
Who cannot join
- 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.
About this study
Official title: Effectiveness of Non-invasive Neuromodulation Treatment (NESA) for the Management of Constipation Without Diagnosed Pathology in Students of the European University of Madrid (Spain)
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
Read the detailed description
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.
It 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 .
Imperceptible 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.
Constipation 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.
Since the etiology and mechanism of constipation are complicated, many of the currently available treatments are not effective for many people.
Given that NESA performs a non-invasive neuromodulation on the ANS through the nerve pathways involved in improving constipation, effects in this regard are expected.
Non-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.
Justification 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
- Conditions
- Constipation
- Being tested
- Non-Invasive Neuromodulation NESA
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Neuromodulation NESADevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Non-Invasive Neuromodulation NESA |
| Placebo | Placebo comparator | Non-active Non-Invasive Neuromodulation NESA Receives: Device: Non-Invasive Neuromodulation NESA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life by constipation (CVE-20)
Questionnaire. https://www.sciencedirect.com/science/article/abs/pii/S0025775308722851#aep-article-footnote-id
Measured: 10 minutes
Secondary outcomes (3)
Sleep Quality
Questionnaire
Measured: 10 minutes
Cardiac Frecuency
Measured with WeCardio.
Measured: 5 minutes
Arterial pressure
With Sfigmomanometer
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanesa Abuín, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294457
- Sponsor's protocol ID
- CI-2024-480
- Status last verified
- Mar 2024
- First submitted
- 19 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Non-invasive Neuromodulation Treatment (NESA) for the Management of Constipation Without Diagnosed Pathology in Students of the European University of Madrid (Spain)
- ClinicalTrials.gov ID
- NCT06294457
- Acronym / sponsor ID
- CI-2024-480
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
It 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 .
Imperceptible 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.
Constipation 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.
Since the etiology and mechanism of constipation are complicated, many of the currently available treatments are not effective for many people.
Given that NESA performs a non-invasive neuromodulation on the ANS through the nerve pathways involved in improving constipation, effects in this regard are expected.
Non-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.
Justification 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Non-Invasive Neuromodulation NESAThe 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. |
| Placebo | Placebo comparator | Device: Non-Invasive Neuromodulation NESANon-active Non-Invasive Neuromodulation NESA |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants from 18 to 65 years old
- Sign informed consent
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Invasive Neuromodulation NESAConsidering 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. | Device | Intervention, Placebo |
Primary outcome
Quality of life by constipation (CVE-20)
Time frame: 10 minutes
Questionnaire. https://www.sciencedirect.com/science/article/abs/pii/S0025775308722851#aep-article-footnote-id
3 secondary outcomes
Sleep Quality
Time frame: 10 minutes
Cardiac Frecuency
Time frame: 5 minutes
Arterial pressure
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- CitationLink provided by the sponsor.
- CitationLink provided by the sponsor.
- CitationLink provided by the sponsor.
- CitationLink provided by the sponsor.
- CitationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Invasive Neuromodulation NESA in people with Constipation, run by Universidad Europea de Madrid.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life by constipation (CVE-20) (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.