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Brain Stimulation

Brain Stimulation for Depression

N/A
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Accompanied by at least two evidence-based augmentation therapies (Benzodiazepines do not count)
Must have confirmed diagnosis of moderate Major Depressive Disorder (single or recurrent episode), minimum score of 17 on the 17-item Hamilton Rating Scale for Depression (HAM-D17). No minimal MDD duration necessary for study participation
Must not have
Have had prior Transcranial Magnetic Stimulation treatment
Neurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, average of 6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of brain stimulation on pain symptoms in people with Major Depressive Disorder. 69 people will receive 30 treatments of transcranial magnetic stimulation and will be compensated $150 for their time.

Who is the study for?
This trial is for adults aged 18-75 with chronic pain and moderate Major Depressive Disorder who haven't improved after at least two different antidepressant medications and psychotherapy. Participants must speak English, be right-handed, have a specific depression score, and not respond to other treatments including psychotherapy.
What is being tested?
The study tests the effects of brain stimulation (rTMS/iTBS) on pain in those with depression. All participants receive active treatment over approximately 30 sessions. They'll complete surveys, undergo blood draws, MRIs, EEGs, and dedicate about 40 hours across up to 33 visits.
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site on the scalp, headache or dizziness post-treatment. There's also a small risk of seizure associated with magnetic stimulation but this is rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am receiving two or more approved additional treatments (not including Benzodiazepines).
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I have been diagnosed with moderate depression and scored at least 17 on the HAM-D17.
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I have been diagnosed with FM or ME/CFS and experience moderate pain.
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My condition did not improve after trying two different types of treatment.
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I have tried at least 2 antidepressants without success.
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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have undergone Transcranial Magnetic Stimulation treatment.
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I have a neurological condition like epilepsy or severe head trauma.
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I have an infection or poor skin condition on my scalp.
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I do not have psychotic symptoms like hallucinations or delusions with my depression.
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I am unable to understand or sign the consent form due to mental or legal reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, average of 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, average of 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent change in depression scores
Percent change in pain score
Secondary study objectives
Levels of inflammatory markers and transcription factors

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Active rTMS/Active iTBS DFPLC/Sham Pain M1Experimental Treatment1 Intervention
Group II: Active rTMS/Active iTBSExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,565 Previous Clinical Trials
10,263,135 Total Patients Enrolled
106 Trials studying Depression
49,554 Patients Enrolled for Depression

Media Library

Active rTMS/Active iTBS (Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04556890 — N/A
Depression Research Study Groups: Active rTMS/Active iTBS DFPLC/Sham Pain M1, Active rTMS/Active iTBS
Depression Clinical Trial 2023: Active rTMS/Active iTBS Highlights & Side Effects. Trial Name: NCT04556890 — N/A
Active rTMS/Active iTBS (Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04556890 — N/A
~30 spots leftby Dec 2026
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