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Repetitive Transcranial Magnetic Stimulation

rTMS for Depression in Multiple Sclerosis

N/A
Recruiting
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who are able and willing to give consent and able to adhere to treatment schedule and attend study visits, as determined by study psychiatrist
DSM-V diagnosis of Major Depressive Disorder (MDD)
Must not have
Having failed a course of ECT in the current episode or previous episode
History of seizures, or currently on anticonvulsant for seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 4 weeks post-treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial will evaluate the safety & tolerability of iTBS rTMS for those w/ MS, as well as its effectiveness & effects on cognition.

Who is the study for?
Adults aged 18-70 with Multiple Sclerosis (MS) and Major Depressive Disorder (MDD), who haven't changed their psychotropic meds in the last 4 weeks. They must be able to commit to the treatment schedule, not have a history of bipolar disorder or substance abuse, no active suicidal intent, not pregnant or lactating, and without certain medical conditions like seizures.
What is being tested?
The trial is testing intermittent Theta Burst (iTBS) repetitive transcranial magnetic stimulation (rTMS) for safety and its ability to reduce depression symptoms in MS patients. iTBS rTMS is an approved therapy but hasn't been specifically tested for safety in this group before.
What are the potential side effects?
While specific side effects are not listed here, common ones from rTMS may include headache, scalp discomfort at the site of stimulation, tingling sensations or twitching facial muscles during treatment sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing and able to follow the study's treatment plan and attend all visits.
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I have been diagnosed with Major Depressive Disorder.
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I am between 18 and 70 years old.
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I agree to use barrier methods of contraception during the study.
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I haven't started or increased any mental health medication in the last 4 weeks.
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My MS diagnosis has been confirmed by a neurologist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had ECT treatment before that did not work for me.
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I have a history of seizures or am currently taking medication for seizures.
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I have been diagnosed with Bipolar Disorder.
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I am taking more than 2 mg of lorazepam or its equivalent.
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I do not have a pacemaker, brain implant, or metal in my head.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 4 weeks post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 4 weeks post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in depressive symptoms
Secondary study objectives
Change in Neuropsychological function
Change in anxiety and depressive symptoms
Change in fatigue, severity and impact

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Left DLPFC iTBS rTMSExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive transcranial magnetic stimulation
2008
Completed Phase 3
~1000

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,565,865 Total Patients Enrolled
5 Trials studying Multiple Sclerosis
598 Patients Enrolled for Multiple Sclerosis

Media Library

L-DLPFC iTBS rTMS (Repetitive Transcranial Magnetic Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04621708 — N/A
Multiple Sclerosis Clinical Trial 2023: L-DLPFC iTBS rTMS Highlights & Side Effects. Trial Name: NCT04621708 — N/A
Multiple Sclerosis Research Study Groups: Left DLPFC iTBS rTMS
L-DLPFC iTBS rTMS (Repetitive Transcranial Magnetic Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04621708 — N/A
~4 spots leftby Nov 2025
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