Repetitive Transcranial Magnetic Stimulation Combined With Anti-inflammatory Diet in Crohn's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Repetitive transcranial magnetic stimulation, Anti-inflammatory diet.
- Who it may be relevant to
- Registry conditions: Crohn's Disease. Basic parameters: 40 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Repetitive Transcranial Magnetic Stimulation Combined With Anti-inflammatory Diet on Constipation and Quality of Life in Patients With Crohn's Disease
Overview
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
- 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.
Primary outcome measures
- Health-Related Quality of Life (HRQOL) [Time frame: 4 weeks]
- Constipation Severity Index (CSI) [Time frame: 4 weeks]
Secondary outcome measures (1)
- Interlukins inflammatory markers (IIM) [Time frame: 4 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Physical Therapy — Giza
Identifiers
NCT: NCT07531342 · 752016