TMS in Inflammatory Bowel Disease

NCT04956159 | Terminated Phase 2

• 1 other identifier: REB20-1272
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Transcranial magnetic stimulation (rTMS) has demonstrated diagnostic and therapeutic potential for a number of conditions and is an approved treatment for depression. Inflammatory Bowel Disease (IBD) has a significant impact on mental health, and comorbid maladaptive behaviors and pain are highly prevalent in patients with IBD and are often under-treated. The investigators predict TMS will improve comorbid maladaptive behavior (heightened interoceptive awareness, sleep, fatigue, catastrophizing, anxiety and depression), reduce pain and improve quality of life in persons with inflammatory bowel disease (IBD). Further, TMS benefits will be associated with changes in gut microbiome as measured by stool, blood and urine samples and normalization of IBD-associated changes in brain structure and/or function as measured by magnetic resonance imaging (MRI).

Conditions

Inflammatory Bowel Diseases; Maladaptive Behavior Associated With Physical Illness

Outcome Measures

Primary Outcomes (1)

• Change in depressive and anxiety symptoms with active iTBS-rTMS as compared to sham treatment group

  Hospital Anxiety and Depression Scale (HADS) will be used to assess anxiety and depression. The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of \>8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.

  Measured at baseline, halfway through rTMS treatment (week 1), end of rTMS treatment (week 2) and 4 weeks post treatment (week 6)

Secondary Outcomes (23)

• 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

  Measured at baseline, halfway through rTMS treatment (week 1), end of rTMS treatment (week 2) and 4 weeks post treatment (week 6)

• Change in mood from baseline to week 2 (post rTMS treatment) with iTBS-rTMS as compared to sham treatment group

  Measured at baseline, halfway through rTMS treatment (week 1), end of rTMS treatment (week 2) and 4 weeks post treatment (week 6)

• Change in IBD symptoms with active iTBS rTMS compared to sham rTMS

  Measured at baseline, halfway through rTMS treatment (week 1), end of rTMS treatment (week 2) and 4 weeks post treatment (week 6)

• Change in quality of life in persons with IBD with active iTBS rTMS compared to sham rTMS

  Measured at baseline, halfway through rTMS treatment (week 1), end of rTMS treatment (week 2) and 4 weeks post treatment (week 6)

• Change in self reported anxiety symptoms in persons with IBD with active iTBS rTMS compared to sham rTMS

  Measured at baseline, halfway through rTMS treatment (week 1), end of rTMS treatment (week 2) and 4 weeks post treatment (week 6)

Other Outcomes (1)

• Side Effects

  Measured at baseline, halfway through rTMS treatment (week 1), end of rTMS treatment (week 2) and 4 weeks post treatment (week 6)

Study Arms (2)

Active iTBS rTMS

ACTIVE COMPARATOR

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.

Device: iTBS repetitive Transcranial Magnetic Stimulation (rTMS)

Sham iTBS rTMS

SHAM COMPARATOR

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.

Device: Sham rTMS

Interventions

iTBS repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

rTMS is a non-invasive procedure in which cerebral electrical activity is influenced by a rapidly changing magnetic field. The magnetic field is created by a plastic-encased coil which is placed over the patient's scalp. The magnetic field can be directed onto specific areas of the brain. rTMS can modulate cerebral activity by low or high frequencies. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of depression and anxiety.

Also known as: MAGPRO X100 stimulator

Active iTBS rTMS

Sham rTMS DEVICE

Sham rTMS involves a click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.

Also known as: MAGPRO X100 stimulator

Sham iTBS rTMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• confirmed diagnosis of IBD, demonstrated to be in endoscopic remission (Mayo Endoscopic Subscore \[for UC\] 0 or 1, or Simple Endoscopic Score for CD ≤4) or biomarker remission (fecal calprotectin \<250 ug/g) within 6 months of randomization
• ≥8 on the Hospital Anxiety and Depression Scale
• on stable IBD-related and psychotropic medications for the four weeks preceding randomization

You may not qualify if:

• severely active IBD (Mayo score \> 9, HBI \> 16)
• require systemic corticosteroids
• initiated biologic treatment within the preceding three months
• suicidal ideation
• psychosis
• having failed ECT
• previous rTMS treatment (for blinding integrity)
• contraindications for MRI
• Use of benzodiazepines or GABA agonists

Sponsors & Collaborators

• University of Calgary: lead
• IMAGINE (Inflammation, Microbiome, and Alimentation: Gastro-Intestinal and Neuropsychiatric Effects): collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: July 9, 2021
• Study Start: November 1, 2021
• Primary Completion: October 7, 2022
• Study Completion: October 7, 2022
• Last Updated: April 18, 2023

Record last verified: 2021-11

Locations

CA (1)