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Non-invasive Brain Stimulation

Non-invasive Brain Stimulation for Depression

N/A
Recruiting
Led By Susanna L Fryer, PhD
Research Sponsored by San Francisco Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All participants must have normal (or corrected to normal) vision
All participants must be 18-65 years old
Must not have
Participants with MDD must not have past or present DSM-5 (SCID-5) Bipolar and Related Disorders Diagnosis
Major medical conditions (e.g., seizure disorders, treatment with anticonvulsant medication, endocrine disorders, significant cardiac pathology), or other physical conditions if they preclude participation in EEG, TMS, or MRI protocols (e.g. peripheral nerve damage, limb paralysis etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up eeg measurements are collected directly after neurostimulation (itbs vs sham) sessions
Awards & highlights

Summary

This trial uses a special type of brain stimulation to target areas involved in reward and motivation in people with major depressive disorder. The goal is to activate these underactive brain areas to improve their response to rewards, potentially helping to alleviate some symptoms of depression. Deep Brain Stimulation (DBS) was originally developed to manage movement disorders like Parkinson's Disease but has shown promise in treating depression by targeting specific brain areas.

Who is the study for?
This trial is for adults aged 18-65 with major depressive disorder (MDD) as defined by the DSM-5. Participants must have normal vision or corrected-to-normal vision, be safety screened for TMS and MRI procedures, and have been on a stable psychiatric medication regime for over a month.
What is being tested?
The study tests intermittent theta burst stimulation (iTBS) using a MagVenture MagPro R30 device to target the brain's reward system in people with MDD. It compares active iTBS treatment to SHAM (inactive) stimulation to see how it affects depression symptoms.
What are the potential side effects?
TMS may cause discomfort at the site of stimulation, headache, lightheadedness, or seizures in rare cases. Most side effects are mild and temporary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My vision is normal, or corrected to normal with glasses or contacts.
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I am between 18 and 65 years old.
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I have been diagnosed with major depressive disorder according to DSM-5.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have major depression but no history of bipolar disorder.
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I do not have major medical conditions that would prevent me from undergoing EEG, TMS, or MRI tests.
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My depression does not include psychotic features.
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I have major depression but no history of schizophrenia or similar conditions.
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I have had neurological issues, like seizures or head injuries affecting my brain function.
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I have claustrophobia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~eeg measurements are collected directly after neurostimulation (itbs vs sham) sessions
This trial's timeline: 3 weeks for screening, Varies for treatment, and eeg measurements are collected directly after neurostimulation (itbs vs sham) sessions for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Targeted neurostimulation effects on reward feedback evaluation
Secondary study objectives
Targeted neurostimulation effects on reward anticipation and late-stage evaluation

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Major Depression Disorder Group: iTBS-EEGExperimental Treatment1 Intervention
Device: MagVenture MagPro R30 device with a Cool-DB80 A/P coil (Farum, Denmark) Stimulation: intermittent theta stimulation (iTBS): the investigators will stimulate a dorsomedial prefrontal cortex target at the scalp location (0x 60y 60z). Standard iTBS of 50Hz triplet bursts, 5 times each second with a 2 s on / 8 s off duty cycle for 600 pulses per hemisphere (1200 pulses total) will be applied for a total stimulation time of 6:40 minutes, per session; total session length, including setup is 10-15 min.
Group II: Baseline Evaluation (Major Depressive Disorder and Healthy Control Groups)Active Control1 Intervention
HC and MDD participants will have visits for clinical assessment and a baseline EEG session to complete reward processing tasks (SLOT AND MID). The SLOT task is a 288-trial EEG task developed in our laboratory. Design features mimic structural characteristics common to real-word slot machines, including sound effects and visualizations, and the display consists of 3 sequentially populated slot reels. Participants initiate each trial via button press, after which timing of the slot reels is automated, such that reward outcome is independent of task performance. The MID task is a 130-trial EEG task designed to model anticipatory and consummatory sub-stages of reward processing in the context of participants being rewarded based on their response times to a cued target detection task.
Group III: Major Depression Disorder Group: SHAM-EEGPlacebo Group1 Intervention
Device: MagVenture MagPro R30 device with a Cool-DB80 A/P coil (Farum, Denmark) Stimulation: sham stimulation (SHAM): Sham stimulation will entail the same procedures for the active stimulation day, but with the sham side of the DB-80 A/P placed exactly on the same anatomical target in the same position and duration, but without any active stimulation. \*Note, iTBS and SHAM stimulation sessions will occur on separate days scheduled one week apart (counterbalanced, across subjects). The two stimulation visits follow identical procedures (with the sole difference being active vs. sham rTMS stimulation), with each followed directly by post-stimulation EEG assessment with SLOT and MID tasks.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for depression include medications like antidepressants, psychotherapy, and neuromodulation techniques such as Transcranial Magnetic Stimulation (TMS). Antidepressants typically work by altering neurotransmitter levels in the brain, such as serotonin, norepinephrine, and dopamine, to improve mood and emotional state. Psychotherapy, including cognitive-behavioral therapy (CBT), helps patients identify and change negative thought patterns and behaviors. TMS uses magnetic fields to stimulate nerve cells in specific brain regions involved in mood regulation, such as the dorsolateral prefrontal cortex. Understanding these mechanisms is crucial for depression patients as it helps tailor treatments to individual needs, potentially improving efficacy and reducing side effects.

Find a Location

Who is running the clinical trial?

San Francisco Veterans Affairs Medical CenterLead Sponsor
49 Previous Clinical Trials
210,796 Total Patients Enrolled
4 Trials studying Depression
748 Patients Enrolled for Depression
Susanna L Fryer, PhDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
150 Total Patients Enrolled
1 Trials studying Depression
150 Patients Enrolled for Depression

Media Library

TMS (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05194098 — N/A
Depression Research Study Groups: Major Depression Disorder Group: iTBS-EEG, Major Depression Disorder Group: SHAM-EEG, Baseline Evaluation (Major Depressive Disorder and Healthy Control Groups)
Depression Clinical Trial 2023: TMS Highlights & Side Effects. Trial Name: NCT05194098 — N/A
TMS (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05194098 — N/A
~0 spots leftby Sep 2024
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