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Non-invasive Brain Stimulation
Transcranial Magnetic Stimulation for Depression
N/A
Recruiting
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediately post-intervention
Awards & highlights
Study Summary
This trial will test whether iTBS can improve symptoms in people with depression by targeting the brain's reward circuit.
Who is the study for?
This trial is for right-handed, English-speaking individuals who experience a lack of pleasure or interest in activities (anhedonia). They must not have metal implants in their head, brain conditions like tumors or multiple sclerosis, substance abuse issues within the last three months, severe mental health disorders that affect safety during the trial, high suicide risk, OCD, or be taking certain medications.Check my eligibility
What is being tested?
The study is testing intermittent theta-burst transcranial magnetic stimulation (iTBS), which is a non-invasive procedure targeting the brain's reward circuit to see if it can improve feelings of pleasure and motivation.See study design
What are the potential side effects?
While iTBS is generally considered safe, potential side effects may include discomfort at the stimulation site on the scalp, headache, lightheadedness or dizziness. Rarely it could cause seizures but this is uncommon.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 15 minutes post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 15 minutes post-intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Anhedonia post-intervention
Change in Anhedonia post-washout
Change in RewP post-intervention measured via EEG
+1 moreSecondary outcome measures
Change in Reward activation measured via fMRI
Change in Reward connectivity measured via fMRI
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MPFC-iTBSExperimental Treatment1 Intervention
Transcranial magnetic stimulation delivered to the medial prefrontal cortex. 600 pulses delivered in 50 Hz bursts every 5 Hz for 2 seconds followed by 8 seconds of no stimulation repeated 20 times at 80% of resting motor threshold. Repeated daily for 5 consecutive days.
Group II: Inion-iTBSActive Control1 Intervention
Transcranial magnetic stimulation delivered to the inion. 600 pulses delivered in 50 Hz bursts every 5 Hz for 2 seconds followed by 8 seconds of no stimulation repeated 20 times at 80% of resting motor threshold. Repeated daily for 5 consecutive days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
transcranial magnetic stimulation
2013
Completed Phase 2
~710
Find a Location
Who is running the clinical trial?
Florida State UniversityLead Sponsor
199 Previous Clinical Trials
31,631 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,707 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a severe brain injury.I do not have dementia or cognitive issues affecting my treatment participation.I have been fluent in English since I was 6 years old.I often feel a lack of pleasure in activities I used to enjoy.I do not have a psychiatric illness that makes it unsafe for me to join the trial.I cannot stop taking medication that increases my risk of seizures.I have a history of brain tumor, stroke, aneurysm, or multiple sclerosis.
Research Study Groups:
This trial has the following groups:- Group 1: MPFC-iTBS
- Group 2: Inion-iTBS
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.
Who can be enrolled in this medical trial?
"This research is recruiting 60 people aged 18 to 55 who are currently receiving transcranial magnetic stimulation (TMS) and meet the following additional requisites: right-hand dominance, native English speaker or proficient by 6 years old, self-reported anhedonia levels."
Answered by AI
Is this experiment open to recruitment at the moment?
"The information posted to clinicaltrials.gov confirms that this trial is presently recruiting participants. This study was first published on July 1st 2022 and has been modified as recently as July 20th 2022."
Answered by AI
How many individuals are involved in this experiment?
"Affirmative. According to clinicaltrials.gov, this scientific investigation is actively recruiting participants who match its criteria. It was first posted on July 1st 2022 and last updated a couple weeks later - it's now looking for 60 patients from a single centre."
Answered by AI
Does this experimental research include participants aged seventy-five and over?
"This research endeavour is seeking out individuals aged between 18 and 55 to take part."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
FSU MRI Facility
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- FSU MRI Facility: < 48 hours
Average response time
- < 2 Days
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