What side effects are associated with this type of intervention?

Common treatments for depression include selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and neuromodulation techniques like repetitive transcranial magnetic stimulation (rTMS). SSRIs and SNRIs can cause side effects such as nausea, headache, sexual dysfunction, and insomnia. rTMS, which is being studied for its potential to disrupt negative emotion patterns, has been associated with mild side effects like lightheadedness, tingling, and tinnitus. Serious adverse events are rare with rTMS.

What prior FDA approvals exist?

The FDA has approved several neuromodulation treatments for depression, including repetitive transcranial magnetic stimulation (rTMS), which has shown efficacy in reducing depressive symptoms by targeting specific brain regions. Other related FDA-approved treatments include transcranial direct current stimulation (tDCS) and vagus nerve stimulation (VNS), both of which have been used as adjunctive therapies for treatment-resistant depression. These treatments aim to modulate brain activity to alleviate depressive symptoms, similar to the goals of patterned rTMS being studied for disrupting negative emotion patterns.

What other types of research exist?

Promising, novel alternatives to patterned repetitive transcranial magnetic stimulation (rTMS) for depression include: 1) Transcutaneous supraorbital nerve stimulation, which has shown efficacy in reducing pain intensity in migraine patients and may have potential for depression treatment. 2) Remote electrical neuromodulation, which has demonstrated significant pain relief in migraine patients and could be explored for depression. 3) Noninvasive vagus nerve stimulation (nVNS), which has shown benefits in treating episodic migraine and may be applicable to depression. These alternatives offer non-invasive options with promising clinical trial results.

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Repetitive Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation for Depression and Anxiety

N/A

Recruiting

Led By Desmond Oathes, PhD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18-65 years old

Be older than 18 years old

Must not have

History of neurological disorder or traumatic brain injury (other than mild)

Unable to receive or tolerate Transcranial Magnetic Stimulation (TMS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help people who experience negative emotions by using a special treatment to reduce these feelings.

Who is the study for?

This trial is for adults aged 18-65 with moderate to severe depression or anxiety, as indicated by a PHQ-9 score of 10 or higher. Participants must be right-handed, understand English instructions, and can consent and commit to the study duration. Exclusions include bipolar disorder, psychotic disorders, recent psychoactive substance use, neurological issues preventing MRI scans or TMS treatment.

What is being tested?

The trial tests personalized brain stimulation using Transcranial Magnetic Stimulation (TMS) to reduce negative emotions in individuals with depression and anxiety. It involves creating unique emotional brain maps via fMRI and muscle activity data then applying tailored TMS sequences over six sessions across three days.

What are the potential side effects?

Potential side effects from TMS may include discomfort at the stimulation site, headache, lightheadedness, tingling sensations on the scalp or face during treatment sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of a serious neurological disorder or traumatic brain injury.

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I cannot undergo or tolerate Transcranial Magnetic Stimulation.

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I have a history of stroke, epilepsy, or brain scarring.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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

Change in ruminative response scale (RRS) score after using the optimal rTMS stimulation frequency vs the least optimal rTMS stimulation frequency

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: Neuromodulation using the optimal rTMS stimulation frequencyExperimental Treatment1 Intervention

Through manipulation of brain state with a negative-affect task and using fMRI as the feedback signal, we aim to fine-tune repetitive Transcranial Magnetic Stimulation (rTMS) delivery to maximally impact the desired brain states in awake behaving study participants in a highly individualized manner (Visit 3: TMS/fMRI). The optimal rTMS stimulation frequency will be tested in a 3-day rTMS neuromodulation intervention.

Group II: Neuromodulation using the least optimal rTMS stimulation frequencyActive Control1 Intervention

We will compare the results of the optimal rTMS frequency neuromodulation with a separate 3-day neuromodulation session using the least optimal rTMS frequency, as determined by Visit 3: TMS/fMRI.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Magnetic Stimulation

2017

Completed Phase 4

~730

0 / 4Eligibility criteria met

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 pharmacotherapy, psychotherapy, and neuromodulation techniques like repetitive transcranial magnetic stimulation (rTMS). Pharmacotherapy typically involves antidepressants that modulate neurotransmitters such as serotonin, norepinephrine, and dopamine to improve mood and emotional regulation. Psychotherapy, including cognitive-behavioral therapy (CBT), helps patients reframe negative thought patterns and develop coping strategies. Neuromodulation techniques like rTMS use magnetic fields to stimulate specific brain regions involved in mood regulation, potentially disrupting negative emotion patterns. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options and manage expectations regarding efficacy and side effects.