All > Inflammatory Bowel Disease

Active iTBS rTMS for Inflammatory Bowel Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Calgary, Calgary, CanadaInflammatory Bowel Disease+1 MoreiTBS repetitive Transcranial Magnetic Stimulation (rTMS) - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will test whether transcranial magnetic stimulation (TMS) can help people with inflammatory bowel disease (IBD) by improving comorbid maladaptive behavior, reducing pain, and improving quality of life.

Eligible Conditions
  • Inflammatory Bowel Disease
  • Maladaptive Behavior Associated With Physical Illness

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 23 Secondary · Reporting Duration: Measured at baseline, halfway through rTMS treatment (week 1), end of rTMS treatment (week 2) and 4 weeks post treatment (week 6)

Week 6
Change in IBD symptoms with active iTBS rTMS compared to sham rTMS
Change in catastrophizing thoughts and feelings in persons with IBD with active iTBS rTMS compared to sham rTMS
Change in depressive and anxiety symptoms with active iTBS-rTMS as compared to sham treatment group
Change in depressive symptoms as measured by Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to week-2 (post rTMS treatment) with iTBS-rTMS as compared to sham treatment group
Change in interoceptive awareness with active iTBS rTMS compared to sham rTMS in persons with IBD.
Change in mood from baseline to week 2 (post rTMS treatment) with iTBS-rTMS as compared to sham treatment group
Change in quality of life in persons with IBD with active iTBS rTMS compared to sham rTMS
Inflammatory Bowel Diseases
Change in self reported anxiety symptoms in persons with IBD with active iTBS rTMS compared to sham rTMS
Change in self reported depressive symptoms in persons with IBD with active iTBS rTMS compared to sham rTMS as measured by the Patient Health Questionaire.
Change in self reported depressive symptoms in persons with IBD with active iTBS rTMS compared to sham rTMS as measured by the Quick Inventory of Depressive Symptomatology
Change in self reported fatigue in persons with IBD with active iTBS rTMS compared to sham rTMS
Change in self reported physical, mental and social health and well-being in persons with IBD with active iTBS rTMS compared to sham rTMS
Inflammatory Bowel Diseases
Side Effects
Week 6
Collagenase Clostridium histolyticum
Collagenase Clostridium histolyticum
Week 6
16S and ITS2 rRNA gene sequencing.
Week 2
Functional Magnetic Resonance Imaging (fMRI)
Magnetic Resonance (MR) spectroscopy
Magnetic Resonance Imaging (MRI)- Inflammation imaging.
Magnetic Resonance Imaging (MRI)- Volumetric imaging.
Magnetic Resonance Imaging (MRI)- White matter imaging
Week 6
Change in cognitive function with active iTBS rTMS compared to sham rTMS in persons with IBD.
Week 6
Implicit Suicidal Thoughts

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

2
TMS+DCS
2
D-Cycloserine
2
MagStim

Trial Design

2 Treatment Groups

Active iTBS rTMS
1 of 2
Sham iTBS rTMS
1 of 2

Active Control

Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: Active iTBS rTMS · Has Placebo Group · Phase 2

Active iTBS rTMS
Device
ActiveComparator Group · 1 Intervention: iTBS repetitive Transcranial Magnetic Stimulation (rTMS) · Intervention Types: Device
Sham iTBS rTMS
Device
ShamComparator Group · 1 Intervention: Sham rTMS · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: measured at baseline, halfway through rtms treatment (week 1), end of rtms treatment (week 2) and 4 weeks post treatment (week 6)

Who is running the clinical trial?

University of CalgaryLead Sponsor
717 Previous Clinical Trials
574,205 Total Patients Enrolled
IMAGINE (Inflammation, Microbiome, and Alimentation: Gastro-Intestinal and Neuropsychiatric Effects)UNKNOWN

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a score of 8 or higher on a mental health questionnaire called the Hospital Anxiety and Depression Scale.
References

Frequently Asked Questions

Are new patients currently being enrolled in this clinical trial?

"Yes, according to the information available on clinicaltrials.gov, this study is still recruiting patients. The trial was first posted on November 1st 2021 and was updated on November 19th 2021. They are looking for 40 individuals from 1 site in total." - Anonymous Online Contributor

Unverified Answer

How risky is Active iTBS rTMS for patients?

"Active iTBS rTMS has not been proven effective, so it received a score of 2." - Anonymous Online Contributor

Unverified Answer

How many people are allowed to take part in this experiment?

"That is correct. The latest information available on clinicaltrials.gov suggests that this trial, which was first advertised on November 1st 2021, is still enrolling patients. So far, 40 people have been accepted at the single location where the trial is taking place." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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