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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
Age 18 to 55
Naïve to rTMS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up neurostimulation visit (which will occur within a month of the initial assessment)
Awards & highlights

Study 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.

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 55 years old.
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I have never undergone rTMS therapy.

Timeline

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

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 more
Secondary 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 more
Other 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 more

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
Cognitive Restructuring
2016
Completed Phase 1
~530
Repetitive Transcranial Magnetic Stimulation (rTMS)
2019
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,419,830 Total Patients Enrolled
4 Trials studying Mood Disorders
317 Patients Enrolled for Mood Disorders
National Institute of Mental Health (NIMH)NIH
2,782 Previous Clinical Trials
2,688,867 Total Patients Enrolled
73 Trials studying Mood Disorders
45,303 Patients Enrolled for Mood Disorders
Andrada D Neacsiu, PhDPrincipal InvestigatorDuke University
3 Previous Clinical Trials
267 Total Patients Enrolled

Media Library

Active Repetitive Transcranial Magnetic Stimulation (rTMS) (Neurostimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05712057 — N/A
Mood Disorders Research Study Groups: Cognitive Restructuring + Repetitive Transcranial Magnetic Stimulation (rTMS), Cognitive Restructuring + scalp electrical stimulation, Emotional Awareness Training + Repetitive Transcranial Magnetic Stimulation (rTMS)
Mood Disorders Clinical Trial 2023: Active Repetitive Transcranial Magnetic Stimulation (rTMS) Highlights & Side Effects. Trial Name: NCT05712057 — N/A
Active Repetitive Transcranial Magnetic Stimulation (rTMS) (Neurostimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05712057 — N/A
Mood Disorders Patient Testimony for trial: Trial Name: NCT05712057 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals being accepted for participation in this clinical experiment?

"As specified by the inclusion criteria, only those between 18 and 55 years of age are eligible for this trial. There are a total of 371 studies catered towards minors and 932 that focus on individuals older than 65."

Answered by AI

Are participants still being enrolled for this clinical research?

"It appears that this particular clinical trial has concluded its recruitment process, as the details available on clinicialtrials.gov indicate no need for further participants. The original posting was made on April 15th 2023 and the last update happened January 25th of the same year. Nonetheless, there are still 1,426 other studies searching for patients right now."

Answered by AI

How can I join this research initiative?

"This clinical trial seeks 240 participants aged 18-55 that display emotion regulation issues as indicated by a Difficulties with Emotion Regulation Scale (DERS) total score of at least 90. Additionally, these individuals must have been in the same psychotherapy program for four weeks prior to joining and not be receiving Cognitive Behavioral Therapy (CBT). Furthermore, they should possess low levels of cognitive restructuring according to the ERQ Restructuring Subscale Average Score and meet criteria for one or more DSM-5 disorders except severe Anorexia. Finally, all candidates need to stay on their current prescribed medication doses throughout the study and be new to transc"

Answered by AI

What endpoints are being sought in this clinical experiment?

"The primary goal of this investigation, to be evaluated within a baseline Neuroimaging Scan and post-stimulation followup period, is to measure Heart Rate Variability (HRV) during stimulus blocks. Secondary outcomes include changes in the Difficulties with Emotion Regulation Scale (DERS), Emotion Regulation Questionnaire (ERQ)-Reappraisal scale scores, and percent signal change in dlPFC for the [restructure - flow_negative] contrast. Inclusion criteria necessitates a DERS score of at least 90/180 or higher."

Answered by AI

Who else is applying?

What state do they live in?
California
Ontario
Other
North Carolina
What site did they apply to?
Duke University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
2
3+

What questions have other patients asked about this trial?

Will you be able to pay for traveling fees?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

Seeking new treatment methods. I need help with regulating my emotions. I have tried many things for treatment and none of them have worked.
PatientReceived no prior treatments
I have been struggling with BPD and would like to help find a way to help the next generation.
PatientReceived 2+ prior treatments
I have tried over 10 antidepressants and mood stabilizers and anxiety medication with no relief for 17 years. The harder I try to get help the harder the system makes it.
PatientReceived no prior treatments
~160 spots leftby May 2027