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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Пищевая добавка 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.

Первичные конечные точки

• Health-Related Quality of Life (HRQOL) [Срок оценки: 4 weeks]
• Constipation Severity Index (CSI) [Срок оценки: 4 weeks]

Вторичные конечные точки (1)

• Interlukins inflammatory markers (IIM) [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• (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.

Критерии исключения

• (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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Physical Therapy — Giza

Идентификаторы

NCT: NCT07531342 · 752016

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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