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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
Summary
This trial evaluates the unique effects of combining cognitive restructuring and rTMS during a one-session training to help regulate emotions. Brain imaging and follow-up visits will be used to assess changes.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreOther outcome measures
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 moreTrial 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
Cognitive Restructuring
2016
Completed Phase 1
~990
Repetitive Transcranial Magnetic Stimulation (rTMS)
2019
Completed Phase 2
~780
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.
Non-invasive and invasive brain stimulation in alcohol use disorders: A critical review of selected human evidence and methodological considerations to guide future research.
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,394 Previous Clinical Trials
3,059,246 Total Patients Enrolled
4 Trials studying Mood Disorders
317 Patients Enrolled for Mood Disorders
National Institute of Mental Health (NIMH)NIH
2,820 Previous Clinical Trials
2,692,579 Total Patients Enrolled
74 Trials studying Mood Disorders
45,345 Patients Enrolled for Mood Disorders
Andrada D Neacsiu, PhDPrincipal InvestigatorDuke University
3 Previous Clinical Trials
267 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses, including serious migraines.I have undergone Transcranial Magnetic Stimulation (TMS) before.I have been diagnosed with or have a history of a psychotic disorder.I have been in the same psychotherapy or none for the last month and am willing to continue it during the study.I am between 18 and 55 years old.I rarely use positive thinking to manage my emotions.I have never undergone rTMS therapy.I do not have a current hypomanic episode.I have been diagnosed with Bipolar I disorder.I have recently started or changed my mental health medication.I am not currently hospitalized for anorexia or a similar condition.I do not have brain-related health issues like increased pressure, lesions, or specific neurological diseases.I agree to keep my mental health medication doses the same during the study.I haven't had seizures, epilepsy, stroke, brain surgery, head injury, or metal implants in my head.I am taking medication that could increase my risk of seizures.I have had cognitive behavioral therapy in the last month or plan to start during the study.You have been diagnosed with a mental health condition such as anxiety, mood disorder or ADHD, but not severe anorexia. You can be currently experiencing symptoms or in partial remission.I have been in the same psychotherapy or none for the last month and am willing to continue it during the study.I am between 18 and 55 years old.I agree to keep my mental health medication dose the same during the study.I rarely use positive thinking to manage my emotions.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive Restructuring + Repetitive Transcranial Magnetic Stimulation (rTMS)
- Group 2: Cognitive Restructuring + scalp electrical stimulation
- Group 3: Emotional Awareness Training + Repetitive Transcranial Magnetic Stimulation (rTMS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Mood Disorders Patient Testimony for trial: Trial Name: NCT05712057 — N/A
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