Decoding and Modulating Affective Brain States (HART)

Brief description of study

The research study is being conducted to study brain patterns of negative emotion and develop personalized brain stimulation protocols to disrupt these patterns with transcranial magnetic stimulation (TMS). First, we will use functional Magnetic Resonance Imaging (fMRI) data to generate a negative affect map for each subject. Then, we will try a variety of repetitive transcranial magnetic stimulation (rTMS) sequences while inside the MRI scanner to determine the optimal and least optimal rTMS frequencies at changing negative affect brain states. Finally, these two frequencies will be tested over two 3-day rTMS neuromodulation sessions to see if they can reduce negative emotions.

Detailed description of study

The study involves 11 visits.

During Visit 1, potential eligible subjects will be scheduled for a screening visit, where informed consent will be obtained prior to any eligibility assessments. Participants who agree to participate will complete multiple questionnaires regarding their medical history, demographics, mood, behaviors, and eligibility to receive MRI and TMS. These procedures will be conducted remotely. If the participant meets the eligibility criteria of the remote assessments, they will be scheduled for an in-person visit for a clinical interview and a TMS demonstration. Patients who meet all eligibility criteria and can tolerate TMS will be enrolled in the study.

Visit 2 will involve a 1 hour MRI scan and an assessment session.

Visit 3 will be a 2-hour TMS/fMRI session, where the participant will engage in a mental task while interleaved rTMS rounds are delivered at different frequencies. This scan will be used to determine the optimal stimulation frequency for the participant.

During the Visits 4-6, or the First Neuromodulation Session, participants will receive rTMS using either the optimal or least optimal rTMS stimulation frequency. They will also complete two computerized tasks after rTMS, with questionnaires in between procedures. After completing these visits, Visit 7 will involve TMS/fMRI session, similar to the procedures conducted in Visit 3.

Please note that Visits 4-7 need to be scheduled during consecutive work days, either Monday-Thursday or Tuesday-Friday.

After two weeks, Visits 8-10 (Second Neuromodulation Session) will mirror Visit 4-6. However, the TMS condition administered (optimal or suboptimal rTMS frequency) will be counterbalanced with the TMS condition used first neuromodulation session. Visit 8 will be scheduled at least 2 weeks after Visit 7. Finally, Visit 11 will mirror the TMS/fMRI procedures of Visit 7.

Please note that Visits 8-11 need to be scheduled during consecutive work days, either Monday-Thursday or Tuesday-Friday.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
Medical Research
Age: - 99 Years
Gender: All

I. Inclusion Criteria

In order to participate in this study, potential participants must meet all of the following eligibility criteria:

1. 18-65 years old

2. PHQ-9 score = or > than 10

3. Comprehension of instructions in the English language.

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

5. Availability for the duration of the study.

II. Exclusion Criteria

Any individual who meets any of the following criteria will be excluded from participation in this study:

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)

III. Lifestyle Considerations

During this study, participants are asked to:

1. Refrain from substance use (including marijuana and illicit drugs) for duration of the study.

2. Abstain from alcohol for 24 hours before the MRI scans.

3. Abstain from increasing caffeine intake or begin taking any new medications for duration of the study.

Updated on 17 Apr 2024. Study ID: 850664

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