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Behavioural Intervention

Active iTBS rTMS for Inflammatory Bowel Disease

Phase 2
Waitlist Available
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline, halfway through rtms treatment (week 1), end of rtms treatment (week 2) and 4 weeks post treatment (week 6)
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline, halfway through rtms treatment (week 1), end of rtms treatment (week 2) and 4 weeks post treatment (week 6)
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline, halfway through rtms treatment (week 1), end of rtms treatment (week 2) and 4 weeks post treatment (week 6) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in depressive and anxiety symptoms with active iTBS-rTMS as compared to sham treatment group
Secondary outcome measures
16S and ITS2 rRNA gene sequencing.
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
+20 more
Other outcome measures
Side Effects

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active iTBS rTMSActive Control1 Intervention
The active arm involves magnetic stimulation of the brain to the left dorsolateral prefrontal cortex (DLPFC) twice daily for two weeks (20 sessions). The active arm will be receiving intermittent Theta-Burst (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) to deliver magnetic pulses.
Group II: Sham iTBS rTMSPlacebo Group1 Intervention
sham rTMS treatment involves scalp stimulation with no magnetic pulse twice daily for two weeks (20 sessions). Sham rTMS involves only the click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered to the brain.

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Who is running the clinical trial?

IMAGINE (Inflammation, Microbiome, and Alimentation: Gastro-Intestinal and Neuropsychiatric Effects)UNKNOWN
University of CalgaryLead Sponsor
795 Previous Clinical Trials
874,567 Total Patients Enrolled
~3 spots leftby Jun 2025
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