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Neuromodulation
Neuromodulation for Depression (TREND Trial)
N/A
Recruiting
Led By Erika E Forbes, Ph.D
Research Sponsored by Erika Forbes
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
Must not have
Neurological disorders: Epilepsy, Parkinson's Disease, brain tumor, brain injury, stroke
History of head trauma with a loss of consciousness (e.g., concussion)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Summary
This trial will study whether theta burst stimulation, a type of magnetic brain stimulation, can help reduce the severity of depression symptoms. A subset of participants will also receive positive affect training.
Who is the study for?
This trial is for individuals with a current diagnosis of depression according to the DSM-5. Participants should not have used certain drugs like cocaine or MDMA recently, have high-risk suicidality, severe substance use disorders, specific medication usage (Clozapine, Bupropion), daily nicotine use, or a history of seizures and other listed conditions.Check my eligibility
What is being tested?
The TREND study is testing theta burst stimulation (TBS) as a treatment for depression. Some participants will also receive positive affect training alongside TBS to see if it helps reduce the severity of depression symptoms more effectively.See study design
What are the potential side effects?
While the side effects are not explicitly mentioned here, similar neuromodulation treatments can sometimes cause headaches, scalp discomfort at the site of stimulation, lightheadedness or short-term changes in thinking or mood.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a neurological disorder such as epilepsy, Parkinson's, brain tumor, brain injury, or stroke.
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I have had a head injury that made me lose consciousness.
Select...
I have a history of seizures.
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I am currently taking benzodiazepines or mood stabilizers.
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I am currently taking Clozapine, Bupropion, or prescription stimulants.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
depression severity
Trial Design
1Treatment groups
Experimental Treatment
Group I: TBSExperimental Treatment1 Intervention
In this open-label trial, all participants will undergo 2 continuous TBS (cTBS) sessions per visit over 10 days (weekdays, over 2 weeks; total = 20 TBS sessions in 10 visits). The total time of each pair of sessions (including pause between sessions) will be approximately 1 hour, with each session lasting approximately 100 seconds.
There is only 1 group and 1 arm of the study. All participants will receive the treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Theta Burst Stimulation
2014
N/A
~140
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Who is running the clinical trial?
Erika ForbesLead Sponsor
2 Previous Clinical Trials
304 Total Patients Enrolled
2 Trials studying Depression
304 Patients Enrolled for Depression
Erika E Forbes, Ph.DPrincipal InvestigatorUniversity of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have consumed a large amount of alcohol within the past week or within the last 12 hours.You have a mental health condition called obsessive-compulsive disorder, which you have had at any point in your life.You have a history of mental illness that included losing touch with reality.You are afraid of being in small or enclosed spaces.You have a medical device implanted in your body.You have a high risk of attempting suicide.You have had a problem with drugs or alcohol within the last 6 months.I am currently taking Clozapine, Bupropion, or prescription stimulants.I am currently taking benzodiazepines or mood stabilizers.You have been diagnosed with bipolar disorder at any point in your life.You are pregnant.You are too big to fit inside the MRI scanner.You use nicotine every day.I have a history of seizures.I have had a head injury that made me lose consciousness.I have a neurological disorder such as epilepsy, Parkinson's, brain tumor, brain injury, or stroke.You are currently diagnosed with Depressive Disorder according to DSM-5.You cannot have an MRI if you are too big for the scanner, have a fear of small spaces, or have metal inside your body that can be affected by the MRI's magnetic field.You have metal in your head or in other parts of your body that are attracted to magnets.
Research Study Groups:
This trial has the following groups:- Group 1: TBS
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.
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