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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, 15 minutes post-intervention

Awards & highlights

No Placebo-Only Group

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.

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.

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, 1 week post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 week post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Anhedonia post-intervention

Change in Anhedonia post-washout

Change in RewP post-intervention measured via EEG

+1 more

Secondary study objectives

Change in Reward activation measured via fMRI

Change in Reward connectivity measured via fMRI

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

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

~760

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