RECRUITING

Decoding and Modulating Affective Brain States

Conditions

Rumination Major Depressive Disorder Anxiety TMS depression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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, the investigators will use functional Magnetic Resonance Imaging (fMRI) data to generate a negative affect map for each participant. Then, the investigators will apply a variety of repetitive transcranial magnetic stimulation (rTMS) sequences while the participant is 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 assess whether they can reduce negative emotions.

Official Title

Decoding and Modulating Affective Brain States

Quick Facts

Study Start:2023-02-21

Study Completion:2028-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05437705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 18-65 years old 2. Patient Health Questionnaire (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.	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) 1. Refrain from substance use (including marijuana and illicit drugs) for duration of the study (self-attestation alone). 2. Abstain from alcohol for 24 hours before the MRI scans (self-attestation alone). 3. Abstain from increasing caffeine intake or begin taking any new medications (self-attestation alone).

Inclusion Criteria

Exclusion Criteria

1. 18-65 years old
2. Patient Health Questionnaire (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.

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)
1. Refrain from substance use (including marijuana and illicit drugs) for duration of the study (self-attestation alone).
2. Abstain from alcohol for 24 hours before the MRI scans (self-attestation alone).
3. Abstain from increasing caffeine intake or begin taking any new medications (self-attestation alone).

Contacts and Locations

Study Contact

Camille Blaine

CONTACT

215-573-0828

camille.blaine@pennmedicine.upenn.edu

Almaris Figueroa-Gonzalez

CONTACT

215-746-6751

almaris.figueroa-gonzalez@pennmedicine.upenn.edu

Principal Investigator

Desmond Oathes, PhD

PRINCIPAL_INVESTIGATOR

Associate Professor of Psychiatry

Study Locations (Sites)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Desmond Oathes, PhD, PRINCIPAL_INVESTIGATOR, Associate Professor of Psychiatry

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-21

Study Completion Date2028-12-01

Study Record Updates

Study Start Date2023-02-21

Study Completion Date2028-12-01

Terms related to this study

Keywords Provided by Researchers

TMS
rumination
depression
anxiety

Additional Relevant MeSH Terms

Rumination
Major Depressive Disorder
Anxiety