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Behavioural Intervention
Transcranial Magnetic Stimulation for Psychological Distress
N/A
Recruiting
Research Sponsored by Ottawa Hospital Research Institute
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 upon study completion (up to 20 months)
Awards & highlights
Study Summary
This trialaims to find an effective and feasible therapy for psychological and existential distress in patients nearing the end of life.
Who is the study for?
This trial is for English-speaking patients with advanced terminal illness who have a life expectancy of over one month and are experiencing significant psychological distress, as shown by specific scores on the Edmonton Symptom Assessment System. It's not suitable for those with brain lesions, inability to stay still during therapy, contraindications to rTMS like metallic implants or pacemakers, seizure disorders, or certain medication use.Check my eligibility
What is being tested?
The study tests repetitive Transcranial Magnetic Stimulation (rTMS) to alleviate psychological distress in terminally ill patients. The trial has two phases: first determining the effective dose of rTMS and then comparing symptom changes before and after treatment using either real or sham rTMS based on earlier findings.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of rTMS may include headaches, scalp discomfort at the site of stimulation, tingling sensations or twitching facial muscles during treatment sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ upon study completion (up to 20 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon study completion (up to 20 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Psychological Distress, Depression
Change in Psychological Distress, Depression and Anxiety
Completion of Follow-up
+2 moreSecondary outcome measures
Anxiety
Death Anxiety
Existential Distress
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: rTMS Intervention GroupExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
repetitive Transcranial Magnetic Stimulation (rTMS)
2014
N/A
~510
Find a Location
Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
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Lotte & John Hecht Memorial FoundationOTHER
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Bruyere Research InstituteOTHER
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are unable to sit up at a 45 degree angle and remain still during treatment.You are a patient with advanced or terminal illness in a palliative care unit or in the community.You are not expected to live for more than one month.You cannot participate if you have metal skull plates, clips, or stimulators, pacemakers or other electronic implants, are pregnant, have recurrent unexplained headaches, have had a previous skull fracture or brain surgery, or are taking medication that lowers seizure threshold.You or a close family member have a history of seizures.You are feeling very sad, anxious or unwell according to a questionnaire called the Edmonton Symptom Assessment System (ESAS).
Research Study Groups:
This trial has the following groups:- Group 1: rTMS Intervention Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
What is the capacity of this trial to accommodate more participants?
"Affirmative. Per the information on clinicaltrials.gov, this medical trial is actively seeking participants and was first posted on November 2nd 2020. The latest update to the study occurred on December 31st 2022 and 15 patients are needed at a single location."
Answered by AI
Are applicants still able to join this clinical trial?
"Affirmative. According to clinicaltrials.gov, the trial posted on November 2nd 2020 is still in search of participants and was recently edited on December 31st 2022. Fifteen patients need to be enrolled from one site for this study."
Answered by AI
What specific goals is this trial attempting to accomplish?
"This clinical trial will assess Change in Psychological Distress, Depression and Anxiety over a set period of time. Secondary outcomes include Death Anxiety (measured with the DAS Scale), Participant Quality of Life (WHOQOL-Bref) and Existential Distress (as scored on the 24-Item Demoralization scale)."
Answered by AI
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