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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07531342
Enrollment
50
Registered
2026-04-15
Start date
2026-05-01
Completion date
2026-07-15
Last updated
2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Crohn's disease, Constipation, Quality of Life, Repetitive Transcranial Magnetic Stimulation, Anti-Inflammatory Diet

Brief summary

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.

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.

Interventions

DEVICERepetitive 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_SUPPLEMENTAnti-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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No

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 and (7) Informed consent was obtained from all patients enrolled in the trial.

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 or (11) significant dermatological conditions at the electrode placement sites on the scalp.

Design outcomes

Primary

MeasureTime frameDescription
Health-Related Quality of Life (HRQOL)4 weeksHRQOL 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.
Constipation Severity Index (CSI)4 weeksCSI 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.

Secondary

MeasureTime frameDescription
Interlukins inflammatory markers (IIM)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.

Countries

Egypt

Contacts

CONTACTMona Mohamed Amin, PHD
monaamin028@gmail.com01151602624
PRINCIPAL_INVESTIGATORResearch Ethical Committee Faculty of Physical Therapy

Cairo University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026