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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 4 weeks post-treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 4 weeks post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 4 weeks post-treatment
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 symptoms
Secondary outcome measures
Change in Neuropsychological function
Change in anxiety and depressive symptoms
Change in fatigue, severity and impact
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
~920
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,287 Total Patients Enrolled
5 Trials studying Multiple Sclerosis
598 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow the study's treatment plan and attend all visits.You have participated in a previous trial involving rTMS.I have had ECT treatment before that did not work for me.You have a personality disorder that is the main health issue.I have a history of seizures or am currently taking medication for seizures.I have been diagnosed with Major Depressive Disorder.I have been diagnosed with Bipolar Disorder.I am taking more than 2 mg of lorazepam or its equivalent.I do not have a pacemaker, brain implant, or metal in my head.I am taking medication that might increase my risk of seizures.I am between 18 and 70 years old.I agree to use barrier methods of contraception during the study.I have been in stable psychotherapy for at least 3 months with no expected changes.I haven't started or increased any mental health medication in the last 4 weeks.My MS diagnosis has been confirmed by a neurologist.You have been using drugs or alcohol heavily in the last three months, except for smoking.You currently have plans to harm yourself.You have experienced hallucinations or delusions in the past or present.My main diagnosis is OCD or PTSD, which affects me more than my depression.You have a laboratory test result that the doctor thinks is important.You have at least a medium level of depression, as measured by the Hamilton Depression Rating Scale (HAMD) score of 16 or higher.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Left DLPFC iTBS rTMS
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals within a certain age range permitted to participate in this research study?
"The minimum age for entry into this trial is 18, and the maximum accepted age is 70."
Answered by AI
Am I eligible to partake in the current research protocol?
"This clinical trial is searching for 20 individuals aged 18 to 70 that suffer from multiple sclerosis. Qualified patients will be enrolled in this experiment."
Answered by AI
Are there openings in this experiment for participants?
"According to clinicaltrials.gov, the trial is currently recruiting participants with an initial posting date of April 30th 2020 and a recent update on March 13th 2023."
Answered by AI
What is the current enrollment count for this experiment?
"Indeed, clinicaltrials.gov indicates that this trial is actively searching for participants. It was initially published on April 30th 2020 and the latest update can be found from March 13th 2023. The study requires a total of 20 patients to enrol at one location."
Answered by AI
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