Decoding and Modulating Affective Brain States

Anxiety Clinical Trial

Official title:

Decoding and Modulating Affective Brain States

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05437705
• Other study ID #: 850664
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2023
• Est. completion date: December 1, 2028

Study information

• Verified date: January 2024
• Source: University of Pennsylvania
• Contact: Sarai Garcia
• Phone: 215-746-6751
• Email: sarai.garcia[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2028
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 Criteria:

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

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 could interfere 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

Related Conditions & MeSH terms

• Anxiety
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Rumination

Intervention

Device:
• Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation (TMS) is a non-invasive form of brain stimulation. TMS can influence activity in various brain regions, and it allows researchers to test or modify brain circuit communication. The MagPro X100* magnetic stimulator and Cool-B65 Butterfly Coil are FDA-approved for rTMS treatments of depression.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ruminative response scale (RRS) score after using the optimal rTMS stimulation frequency vs the least optimal rTMS stimulation frequency	By comparing the RRS score change pre/post rTMS of both neuromodulation sessions (Visits 4-6/7-9) we will see if our optimal rTMS stimulation frequency is more effective at improving clinical outcomes.	Up to 4 weeks