Decoding and Modulating Affective Brain States

Last updated: July 19, 2024
Sponsor: University of Pennsylvania
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bulimia

Depression (Major/severe)

Depression

Treatment

Transcranial Magnetic Stimulation

Clinical Study ID

NCT05437705
850664
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. 18-65 years old

  2. Right-handed

  3. Patient Health Questionnaire (PHQ-9 score) = or > than 10

  4. Comprehension of instructions in the English language.

  5. Capacity to provide informed consent and follow study procedures.

  6. Availability for the duration of the study.

Exclusion

Exclusion Criteria:

  1. Diagnosis of bipolar disorder (as PI discretion), schizophrenia or other psychoticdisorder

  2. Recent use of psychoactive medications or substances as determined by investigators

  3. History of neurological disorder or traumatic brain injury (other than mild)

  4. Unable to have an MRI scan, or current or prior medical condition that couldinterfere with the collection or interpretation of MRI data

  5. Unable to receive or tolerate TMS

  6. Implanted devices, such as an aneurysm clip or cardiac pacemaker

  7. History of stroke, epilepsy, or brain scarring

  8. Pregnant, nursing, or trying to become pregnant (self-attestation alone)

  9. Otherwise determined by investigator to be unfit for study

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Transcranial Magnetic Stimulation
Phase:
Study Start date:
February 21, 2023
Estimated Completion Date:
December 01, 2028

Study 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.

Connect with a study center

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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