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Neurostimulation + Therapy for Emotional Regulation Issues
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.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- 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)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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"
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."
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