What side effects are associated with this type of intervention?

Excitatory repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (dlPFC) is generally well-tolerated, with common side effects including mild headaches, scalp discomfort at the stimulation site, and, rarely, brief episodes of lightheadedness. Serious adverse events are uncommon. Other neuromodulation techniques, such as transcranial magnetic stimulation (TMS) and noninvasive vagus nerve stimulation (nVNS), share similar side effects, including mild discomfort and transient sensations at the application site. These treatments are considered safe, with no significant long-term adverse effects reported.

What prior FDA approvals exist?

The FDA has approved several neuromodulation techniques for the treatment of mood disorders. Transcranial Magnetic Stimulation (TMS) is approved for major depressive disorder, showing efficacy in patients who do not respond to first-line treatments. Vagus Nerve Stimulation (VNS) is another FDA-approved method for treatment-resistant depression. Electroconvulsive Therapy (ECT) is also widely used and approved for severe depression, including bipolar depression. These treatments modulate neural activity to improve mood regulation, similar to the investigational use of excitatory rTMS over the dorsolateral prefrontal cortex (dlPFC).

What other types of research exist?

Promising novel alternatives to excitatory rTMS over the dlPFC for mood disorders include transcranial direct current stimulation (tDCS), which has shown potential in improving symptoms of depression and anxiety. Another alternative is vagal nerve stimulation (VNS), which has been associated with reduced symptoms in treatment-resistant depression. Both methods are being actively researched and have shown encouraging preliminary results.

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Neurostimulation

Neurostimulation + Therapy for Emotional Regulation Issues

N/A

Recruiting

Led By Andrada D Neacsiu, PhD

Research Sponsored by Duke 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 neurostimulation visit (which will occur within a month of the initial assessment)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new method that combines teaching emotion management skills with a type of brain stimulation. The goal is to help adults who struggle to calm down when upset and have certain mental health conditions. The brain stimulation aims to make it easier for them to learn and use these skills effectively.

Who is the study for?

This trial is for adults aged 18-55 who struggle with emotional regulation and have been diagnosed with certain mood, anxiety, stress-related, impulse control, ADHD or eating disorders. They must score high on the Emotion Regulation Scale and agree to keep their psychotherapy and medication doses consistent throughout the study. People are excluded if they have severe psychiatric conditions like bipolar I disorder or psychosis, substance abuse issues, a low verbal IQ, serious medical illnesses that could interfere with neurostimulation or MRI scans.

What is being tested?

The trial tests how well one-session training combining emotion regulation skills with excitatory repetitive transcranial magnetic stimulation (rTMS) over the prefrontal cortex affects brain function and behavior. It compares this combined intervention against each component alone using fMRI imaging before and after treatment to identify changes in neural networks related to emotion regulation.

What are the potential side effects?

Potential side effects from rTMS may include discomfort at the stimulation site, headache, lightheadedness or seizures in very rare cases. Emotional awareness training generally does not cause significant side effects but can sometimes bring up uncomfortable emotions during practice.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 week follow-up after neurostimulation, 1 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 week follow-up after neurostimulation, 1 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week follow-up after neurostimulation, 1 month follow-up 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 dorsolateral prefrontal cortex (dlPFC)-amygdala connectivity during [restructure - flow_negative]

Change in dorsolateral prefrontal cortex (dlPFC)-insula connectivity during [restructure - flow_negative]

Change in the dorsomedial prefrontal cortex (dmPFC) for the [restructure-flow_negative] contrast

+5 more

Secondary study objectives

Change in subjective units of distress (SUDS)

Change in the amygdala for the [restructure - flow_negative] contrast

Change in the dlPFC for the [restructure - flow_negative] contrast

+7 more

Other study objectives

Affect Intensity Measure (AIM)

Change in vmPFC-insula connectivity during [restructure - flow_negative]

Cognitive flexibility inventory (CFI) and cognitive control and flexibility inventory (CCFI)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive Restructuring + Repetitive Transcranial Magnetic Stimulation (rTMS)Experimental Treatment2 Interventions

Group 1 (G1)- 80 eligible participants will receive training in Cognitive Restructuring (CR). These participants will use CR while receiving rTMS over their individual dlPFC target and will partake in short term and long term follow up testing.

Group II: Cognitive Restructuring + scalp electrical stimulationActive Control2 Interventions

Group 2 (G2) - 80 eligible participants will receive training in CR. These participants will use CR while receiving scalp electrical stimulation over their individual dlPFC target and will partake in short term and long term follow up testing.

Group III: Emotional Awareness Training + Repetitive Transcranial Magnetic Stimulation (rTMS)Active Control2 Interventions

Group 3 (G3) - 80 eligible participants will receive emotional awareness training. These participants will receive rTMS over their individual dlPFC target and will partake in short term and long term follow up testing.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Repetitive Transcranial Magnetic Stimulation (rTMS)

2019

Completed Phase 2

~780

Cognitive Restructuring

2016

Completed Phase 1

~990

Do I qualify?Apply below to find out

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 mood disorders, such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS), work by modulating neural activity in specific brain regions like the dorsolateral prefrontal cortex (dlPFC). rTMS uses magnetic fields to induce electrical currents, enhancing or inhibiting neural activity to improve emotion regulation and cognitive control. tDCS applies a low electrical current to alter neuronal excitability, potentially reducing symptoms of depression. Electroconvulsive therapy (ECT) induces controlled seizures to reset neural circuits, while vagus nerve stimulation (VNS) sends electrical impulses to the brain to modulate mood-related pathways. These mechanisms are vital for mood disorder patients as they target the underlying neural dysfunctions, offering alternative options when traditional pharmacotherapy is ineffective.

Non-invasive and invasive brain stimulation in alcohol use disorders: A critical review of selected human evidence and methodological considerations to guide future research.