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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2026
CompletedFirst Posted
Study publicly available on registry
April 15, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
Study Completion
Last participant's last visit for all outcomes
July 15, 2026
April 15, 2026
April 1, 2026
2 months
April 9, 2026
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Health-Related Quality of Life (HRQOL)
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)
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 Outcomes (1)
Interlukins inflammatory markers (IIM)
4 weeks
Study Arms (2)
Repetitive transcranial magnetic stimulation combined with anti-inflammatory diet
EXPERIMENTAL25 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.
Anti-inflammatory diet
EXPERIMENTAL25 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.
Interventions
Patients received unprocessed, anti-inflammatory foods, rich in microbiota-accessible carbohydrates, lean protein, and omega-3 fatty acids for a period of 4 weeks.
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.
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Physical Therapy
Giza, 12613, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Research Ethical Committee Faculty of Physical Therapy
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer at Department of Surgery and Burn - Faculty of Physical Therapy - Cairo University
Study Record Dates
First Submitted
April 9, 2026
First Posted
April 15, 2026
Study Start (Estimated)
May 1, 2026
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 15, 2026
Last Updated
April 15, 2026
Record last verified: 2026-04