Anxiety Clinical Trial - Decoding & Modulating Affective Brain States

Status Recruiting

Clinical Trial Summary

Generating personalized brain signatures of negative emotion along with personalized brain stimulation protocols to disrupt these patterns. We plan to use fMRI and muscle activity data to determine negative affect maps for each participant. We will then try a variety of patterned repetitive transcranial magnetic stimulation sequences while recording fMRI which will be the basis of two sessions of 3-day individualized brain stimulation designed to reduce negative affect.

Clinical Trial Description

The study involves 9 visits and 4 optional visits. Visit 1 will consist of a consenting and extended screening visit. Visit 2 will involve a 1hour MRI scan and an assessment session. The MRI scan will include both structural and functional scans, facial electromyography (EMG) recordings, cognitive tasks, and multiple questionnaires.Visit 3 will be a 2-hour TMS/fMRI session, where the participant will engage in behavioral tasks while interleaved rTMS rounds are delivered at different excitatory frequencies. This scan will be used to determine the optimal stimulation frequency for the participant. During the Visits 4-6, participants will receive rTMS using either the optimal or least optimal rTMS stimulation frequency. They will also complete a worry induction or relaxation task before and after rTMS, with assessments in between. We will counterbalance whether do worry or relax first. After these visits there will be two optional MRI scans, one similar to Visit 2, and another similar to TMS/fMRI visit. After two weeks, the study Visits 7-9 will mirror the Visits 4-6 study visits, however the rTMS stimulation frequency used would be counterbalanced. The order of optimized and least-optimized frequencies will be counterbalanced across participants between Visit 4-6 and Visit 7-9 (i.e. half of the participants will receive stimulations of the two frequencies in one order, and the other half will receive stimulations of the two frequencies in the reverse order). After this second round of neuromodulation, the same optional visits will be repeated. These optional visits will examine brain and behavioral changes after each round of neuromodulation. After completing all procedures, participants will receive the study compensation. Payment procedures completed may be given earlier if participants withdraw from the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05437705
Study type	Interventional
Source	University of Pennsylvania
Contact	Sarai Garcia
Phone	215-746-6751
Email	sarai.garcia@pennmedicine.upenn.edu
Status	Recruiting
Phase	N/A
Start date	April 21, 2023
Completion date	December 1, 2028

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Decoding and Modulating Affective Brain States

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms