Repetitive Transcranial Magnetic Stimulation Combined With Anti-inflammatory Diet in Crohn's Disease

May 31, 2026 updated by: Mona Mohamed Amin Ziethar, Cairo University

The Effect of Repetitive Transcranial Magnetic Stimulation Combined With Anti-inflammatory Diet on Constipation and Quality of Life in Patients With Crohn's Disease

Fifty six patients with Crohn's disease of both genders with age 40 - 60 year old suffering from constipation, physical and functional limitations participated in this study. The participants were selected from Outpatient clinic of Faculty of Physical Therapy, Suez Canal University, Egypt and randomly distributed into two groups equal in number. Group (A): 25 patients who received rTMS 5 times per week in addition to anti-inflammatory diet for 4 weeks. While, Group (B): 25 patients received anti-inflammatory diet program for 4 weeks. Primary outcome measures were Quality of life questionnaire and Constipation severity index while Interlukins inflammatory markers was the secondary outcome measure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Subjects:

    Fifty six patients of both genders with age 40 - 60 year old suffering from suffering from constipation, physical and functional limitations will participate in this study. The participants will be selected from Outpatient clinic of Faculty of Physical Therapy, Suez Canal University, Egypt and randomly distributed into two groups equal in number.

    Group (A): 25 patients who received rTMS 5 times per week in addition to anti-inflammatory diet for 4 weeks.

    Group (B): 25 patients received anti-inflammatory diet program for 4 weeks.

  2. Equipment:

Therapeutic equipment:

  • Repetitive transcranial magnetic stimulation: a non-invasive treatment modality that operates by generating a strong magnetic field through brief, high-intensity electric currents within a coil. This magnetic field penetrates the scalp and skull without attenuation, producing localized induced electric fields in targeted brain regions.
  • Anti-inflammatory diet: Eating certain foods to increase the good bacteria and thus improve your intestinal flora as kefir, yogurt, sauerkraut, and kombucha.

Measurement equipment:

  • Health-Related Quality of Life (HRQOL): serving as a primary indicator of therapeutic success. In patients with CD, HRQOL is often compromised by both physical symptoms and psychological distress. Utilizing specialized instruments such as the Inflammatory Bowel Disease Questionnaire (IBDQ) or the Short Form-36 (SF-36) allows researchers to quantify the holistic benefits of multimodal interventions, including neuromodulation via rTMS and dietary modifications, which aim to alleviate the psychosocial burden and functional limitations associated with chronic intestinal inflammation.
  • Constipation Severity Index (CSI): evaluating the intensity of these symptoms across sub-domains including obstructive defecation and colonic inertia. In the context of rTMS and anti-inflammatory diets, the CSI provides a sensitive measure to track how brain-gut axis modulation influences bowel frequency and ease of evacuation, offering a standardized numerical value to assess the reduction in clinical symptom severity over the course of the intervention.
  • Interlukins inflammatory markers (IIM): particularly pro-inflammatory cytokines such as IL-6, IL-1β, and IL-17, are central to the pathogenesis of Crohn's disease, driving the transmural inflammatory response and tissue damage. Monitoring these biomarkers offers objective evidence of systemic and mucosal inflammation levels.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Giza, Egypt, 12613
        • Recruiting
        • Faculty of Physical Therapy
        • Contact:
          • Research Ethical Committee Faculty of Physical Therapy
          • Phone Number: 01151312322
          • Email: eth.com@pt.cu.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (1) Patients' age was ranged between 40-60 years old, (2) Both gender 50 patients participated in this study, (3) moderately to severely active refractory CD > 4 months after diagnosis, (4) All the patients were free from genitourinary infections, (5) Neurologically free patient, (6) Patients who were able to comprehend command and willing to participate in the study, (7) Informed consent was obtained from all patients enrolled in the trial, (8) Clinical diagnosis of Alzheimer's Disease and (9) Must be able to swallow tablets.

Exclusion Criteria:

  • (1) Epilepsy or seizures, (2) Metal implants in the head, skull, or neck, (3) Implanted medical devices, (4) Severe traumatic brain injury, (5) Skull fracture, (6) brain surgery, (7) Any neurological disorders that may increase risk, (8) severe cardiovascular conditions, (9) severe psychiatric disorders, (10) skin lesions, infections, (11) significant dermatological conditions at the electrode placement sites on the scalp, (12) Insulin dependent diabetes and (13) Thyroid disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Repetitive transcranial magnetic stimulation combined with anti-inflammatory diet
25 patients received 1 Hz rTMS, the right dorsolateral prefrontal cortex (DLPFC) was selected as the stimulation site plus anti-inflammatory diet (unprocessed, anti-inflammatory foods, rich in microbiota-accessible carbohydrates, lean protein, and omega-3 fatty acids) for a period of 4 weeks.
Device: Repetitive transcranial magnetic stimulation
Patients received 1 Hz rTMS, the right dorsolateral prefrontal cortex (DLPFC) was selected as the stimulation site. The stimulation frequency was set to 1 Hz for a period of 4 weeks.
Dietary supplement: Anti-inflammatory diet
Patients received unprocessed, anti-inflammatory foods, rich in microbiota-accessible carbohydrates, lean protein, and omega-3 fatty acids for a period of 4 weeks.
Experimental: Anti-inflammatory diet
25 patients received anti-inflammatory diet (unprocessed, anti-inflammatory foods, rich in microbiota-accessible carbohydrates, lean protein, and omega-3 fatty acids) for a period of 4 weeks.
Dietary supplement: Anti-inflammatory diet
Patients received unprocessed, anti-inflammatory foods, rich in microbiota-accessible carbohydrates, lean protein, and omega-3 fatty acids for a period of 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-Related Quality of Life (HRQOL)
Time Frame: 4 weeks
HRQOL is serving as a primary indicator of therapeutic success. In patients with CD, HRQOL is often compromised by both physical symptoms and psychological distress. Utilizing specialized instruments such as the Inflammatory Bowel Disease Questionnaire (IBDQ) or the Short Form-36 (SF-36) allows researchers to quantify the holistic benefits of multimodal interventions, including neuromodulation via rTMS and dietary modifications, which aim to alleviate the psychosocial burden and functional limitations associated with chronic intestinal inflammation.
4 weeks
Constipation Severity Index (CSI)
Time Frame: 4 weeks
CSI is evaluating the intensity of these symptoms across sub-domains including obstructive defecation and colonic inertia. In the context of rTMS and anti-inflammatory diets, the CSI provides a sensitive measure to track how brain-gut axis modulation influences bowel frequency and ease of evacuation, offering a standardized numerical value to assess the reduction in clinical symptom severity over the course of the intervention.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interlukins inflammatory markers (IIM)
Time Frame: 4 weeks
(IIM) particularly pro-inflammatory cytokines such as IL-6, IL-1β, and IL-17, are central to the pathogenesis of Crohn's disease, driving the transmural inflammatory response and tissue damage. Monitoring these biomarkers offers objective evidence of systemic and mucosal inflammation levels.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Research Ethical Committee Faculty of Physical Therapy, Cairo university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 752016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohn's Disease

Clinical Trials on Repetitive transcranial magnetic stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe