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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 weeks3 visits

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)

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

IMAGINE (Inflammation, Microbiome, and Alimentation: Gastro-Intestinal and Neuropsychiatric Effects)UNKNOWN

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,142 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

How risky is Active iTBS rTMS for patients?

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

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TMS in Inflammatory Bowel Disease

2021. "TMS in Inflammatory Bowel Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04956159.