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Repetitive Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation for Depression and Anxiety
N/A
Recruiting
Led By Desmond Oathes, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 18-65 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks
Awards & highlights
Study Summary
This trial will use fMRI and muscle activity data to determine negative affect maps for each participant. They will then try a variety of patterned repetitive transcranial magnetic stimulation sequences while recording fMRI which will be the basis of two sessions of 3-day individualized brain stimulation designed to reduce negative affect.
Who is the study for?
This trial is for adults aged 18-65 with moderate to severe depression or anxiety, as indicated by a PHQ-9 score of 10 or higher. Participants must be right-handed, understand English instructions, and can consent and commit to the study duration. Exclusions include bipolar disorder, psychotic disorders, recent psychoactive substance use, neurological issues preventing MRI scans or TMS treatment.Check my eligibility
What is being tested?
The trial tests personalized brain stimulation using Transcranial Magnetic Stimulation (TMS) to reduce negative emotions in individuals with depression and anxiety. It involves creating unique emotional brain maps via fMRI and muscle activity data then applying tailored TMS sequences over six sessions across three days.See study design
What are the potential side effects?
Potential side effects from TMS may include discomfort at the stimulation site, headache, lightheadedness, tingling sensations on the scalp or face during treatment sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in ruminative response scale (RRS) score after using the optimal rTMS stimulation frequency vs the least optimal rTMS stimulation frequency
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Neuromodulation using the optimal rTMS stimulation frequencyExperimental Treatment1 Intervention
Through manipulation of brain state with a negative-affect task and using fMRI as the feedback signal, we aim to fine-tune repetitive Transcranial Magnetic Stimulation (rTMS) delivery to maximally impact the desired brain states in awake behaving study participants in a highly individualized manner (Visit 3: TMS/fMRI). The optimal rTMS stimulation frequency will be tested in a 3-day rTMS neuromodulation intervention.
Group II: Neuromodulation using the least optimal rTMS stimulation frequencyActive Control1 Intervention
We will compare the results of the optimal rTMS frequency neuromodulation with a separate 3-day neuromodulation session using the least optimal rTMS frequency, as determined by Visit 3: TMS/fMRI.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Magnetic Stimulation
2017
Completed Phase 4
~730
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,169 Total Patients Enrolled
69 Trials studying Depression
29,408 Patients Enrolled for Depression
Desmond Oathes, PhDPrincipal InvestigatorAssistant Professor of Psychiatry
1 Previous Clinical Trials
41 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the study and can follow its procedures.You are able to understand instructions given in English.I understand the study and can follow its procedures.I have a history of a serious neurological disorder or traumatic brain injury.I am between 18 and 65 years old.I cannot undergo or tolerate Transcranial Magnetic Stimulation.I am between 18 and 65 years old.I have a history of stroke, epilepsy, or brain scarring.Your PHQ-9 score is 10 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Neuromodulation using the optimal rTMS stimulation frequency
- Group 2: Neuromodulation using the least optimal rTMS stimulation frequency
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.
Are elderly individuals being accepted as participants in this clinical investigation?
"According to the conditions of this trial, only participants between 18 and 65 years old may be eligible. There are 177 studies available for patients below eighteen while 858 exist for those over sixty-five."
Answered by AI
Who meets the criteria to be accepted into this medical experiment?
"This medical trial requires 40 volunteers aged between 18 and 65, who have been diagnosed with major depressive disorder (MDD). Additionally, applicants must be right-handed citizens of the United States that possess capacity for informed consent, adhere to study protocol throughout its duration as well as exhibit a PHQ-9 score greater than 10. Furthermore, comprehension of spoken English is essential for participation."
Answered by AI
Are there still open enrolment opportunities for this clinical trial?
"As seen on clinicaltrials.gov, this experiment is no longer recruiting people for participation. The trial was originally posted in December 1st 2022 and last edited August 30th of the same year. Fortunately, there are 1176 other trials actively seeking candidates at present."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
Tried Lexapro, Wellbutrin and another. Surgical accident destroyed the mental nerve and left me in chronic pain depression and anxiety that was disabling 15 years ago. Disabled and retired.
PatientReceived 1 prior treatment
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