RECRUITING

Neuromodulation of Brain and Emotional Responses to Psychological Stress

Conditions

Healthy Anxiety stress emotion transcranial magnetic stimulation TMS functional Magnetic Resonance Imaging fMRI neuromodulation cardiovascular

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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

Investigators are conducting this study to test if temporarily and non-invasively stimulating the brain will affect the emotional response to stress in healthy participants. Participants will perform a series of tasks while completing an MRI scan. After this, participants will be randomized to undergo transcranial magnetic stimulation (TMS) at two visits, undergoing active stimulation at one visit and undergoing 'sham' stimulation at another visit. Immediately following both stimulation sessions, participants will repeat the tasks during MRI scanning.

Official Title

Neuromodulation of Brain and Emotional Responses to Psychological Stress

Quick Facts

Study Start:2025-04-09

Study Completion:2029-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06603064

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:30 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 30 to 50 2. English language proficiency (English as the primary language used in the home for the past 10 years) 3. Report that they will reside in the Pittsburgh area for at least 6 weeks, to maintain scheduling availability	1. Medication Use 1. The following medications can affect brain and cardiovascular measures being obtained in this study; thus, use of the following medications on one or more occasions in the past 14 days constitutes grounds for exclusion: * Antihypertensive or cardiac medications (diuretics, beta blockers, calcium channel blockers, ACE inhibitor/ARB, cardiac glycosides, central sympatholytic HTN drugs, anti-arrhythmic drugs, vasodilator drugs, other cardiac drugs) * Anticonvulsant medications * Anti-Parkinson medications * Protease inhibitors or other Anti-HIV medications * Medications for the treatment of mania, including antipsychotics * All other centrally active or psychotropic medications, excluding anxiolytic and antidepressant medications. * Insulin * Chemotherapy * Immunosuppressants and related biological agents (Imuran, methotrexate, and cyclophosphamide) * Prescription weight loss medications and ephedrine OTC 2. Reported use of the following medications on a "regular" basis is grounds for exclusion. For this purpose, "regular use" is defined as reporting that the prescribed medication was taken 7 or more days in the past 14 days. Individuals who take these medications, but less frequently than 7 out of the past 14 days are not excluded: * Short-lasting benzodiazepines * Asthma oral medications * Asthma/allergy inhalants * Antidepressant medications * Glucocorticoids (e.g., oral prednisone, cortisol) * Medical marijuana 3. The following medications can affect the CNS for 24 hours following administration; thus, reported use of the following medications within 48 hours of scanning is excluded: * Longer acting benzodiazepines * Sleep medications (e.g., trazodone) 4. Reported use of more than 2 non-insulin medications for diabetes on a "regular" basis is grounds for exclusion. For this purpose, reported use of combination medications, involving two or more non-insulin medications for diabetes in a single pill, is counted as 2 separate medications and would be grounds for exclusion. 5. A person who reports that he or she was once on a disallowed medication but has discontinued this medication for at least a month or longer and is otherwise eligible, is allowed to participate in the study. 2. Substance use exclusions: 1. Anyone reporting 35 or more alcoholic drinks in the last 7 days is excluded. 2. Anyone reporting consumption of 6 or more alcoholic drinks on 3 or more occasions in the past 7 days is excluded. 3. Anyone reporting use of illicit drugs on 7 or more days in the past 2 weeks is excluded. 3. Medical conditions: 1. Epilepsy or a history of seizures. 2. Self-reported prior heart attack, stroke, bypass surgery, angioplasty, congestive heart failure, arrhythmia (cardiac rhythm problems). 3. Severe hypertension (SBP/DBP \> 160/and/or \>100 mmHg) 4. Cancer (treatment in last 12 months, allowances for non-melanoma skin cancer) 5. Liver disease 6. Kidney disease 7. Type I diabetes 8. Self-reported history of a major neurological disorder or brain injury resulting in ongoing symptoms or cognitive impairment (e.g., multiple sclerosis, cerebral palsy, major head injury) 9. Self-reported chronic psychotic illness (schizophrenia, bipolar disorder) 10. Lung disease requiring drug treatment (note however that asthma or allergy inhalers are not exclusionary unless they are used on a "regular basis") 4. Pregnant participants, or participants actively planning to become pregnant in the next 3 months, are excluded. 5. Those with a visual impairment that would prevent them from reading printed text or text on a computer screen, iPad, or other electronic device are excluded. 6. Those with color blindness, who may not be able to distinguish colors on some of the tasks used in this study, are excluded. 7. Those who report that they are not comfortable with undergoing MRI because of the confined space would be excluded. If individuals are interested in the study, but unsure about their comfortability with undergoing an MRI, then they would be given the option to try going into a mock MRI, which is a replica of an MRI scanner. This is meant to aid interested individuals in determining whether they are comfortable with having an MRI. If they report that they are comfortable after this experience, then they would be eligible to continue. If not, then they would be discontinued from further participation. 8. Those who use certain medical devices, implants, or other metal objects in or on the body that cannot be removed and are incompatible with use of fMRI (for example, tattooed eyeliner) are excluded. Many devices can be deemed MRI compatible with the make and model of medical device. If a participant reports a metal medical device, a letter from a medical professional with the make and model number of the device may be used to assess compatibility. 9. Those who are unable to fit into an MRI scanner (over 7ft2in tall or greater than 350lbs weight) are excluded. 10. Those who report working the night shift on a frequent basis (half or more of the hours worked in a full workday are between midnight and 8 am, and this has occurred more than 12 times during the past year) are excluded.

Inclusion Criteria

Exclusion Criteria

1. Age 30 to 50
2. English language proficiency (English as the primary language used in the home for the past 10 years)
3. Report that they will reside in the Pittsburgh area for at least 6 weeks, to maintain scheduling availability

1. Medication Use
1. The following medications can affect brain and cardiovascular measures being obtained in this study; thus, use of the following medications on one or more occasions in the past 14 days constitutes grounds for exclusion:
* Antihypertensive or cardiac medications (diuretics, beta blockers, calcium channel blockers, ACE inhibitor/ARB, cardiac glycosides, central sympatholytic HTN drugs, anti-arrhythmic drugs, vasodilator drugs, other cardiac drugs)
* Anticonvulsant medications
* Anti-Parkinson medications
* Protease inhibitors or other Anti-HIV medications
* Medications for the treatment of mania, including antipsychotics
* All other centrally active or psychotropic medications, excluding anxiolytic and antidepressant medications.
* Insulin
* Chemotherapy
* Immunosuppressants and related biological agents (Imuran, methotrexate, and cyclophosphamide)
* Prescription weight loss medications and ephedrine OTC
2. Reported use of the following medications on a "regular" basis is grounds for exclusion. For this purpose, "regular use" is defined as reporting that the prescribed medication was taken 7 or more days in the past 14 days. Individuals who take these medications, but less frequently than 7 out of the past 14 days are not excluded:
* Short-lasting benzodiazepines
* Asthma oral medications
* Asthma/allergy inhalants
* Antidepressant medications
* Glucocorticoids (e.g., oral prednisone, cortisol)
* Medical marijuana
3. The following medications can affect the CNS for 24 hours following administration; thus, reported use of the following medications within 48 hours of scanning is excluded:
* Longer acting benzodiazepines
* Sleep medications (e.g., trazodone)
4. Reported use of more than 2 non-insulin medications for diabetes on a "regular" basis is grounds for exclusion. For this purpose, reported use of combination medications, involving two or more non-insulin medications for diabetes in a single pill, is counted as 2 separate medications and would be grounds for exclusion.
5. A person who reports that he or she was once on a disallowed medication but has discontinued this medication for at least a month or longer and is otherwise eligible, is allowed to participate in the study.
2. Substance use exclusions:
1. Anyone reporting 35 or more alcoholic drinks in the last 7 days is excluded.
2. Anyone reporting consumption of 6 or more alcoholic drinks on 3 or more occasions in the past 7 days is excluded.
3. Anyone reporting use of illicit drugs on 7 or more days in the past 2 weeks is excluded.
3. Medical conditions:
1. Epilepsy or a history of seizures.
2. Self-reported prior heart attack, stroke, bypass surgery, angioplasty, congestive heart failure, arrhythmia (cardiac rhythm problems).
3. Severe hypertension (SBP/DBP \> 160/and/or \>100 mmHg)
4. Cancer (treatment in last 12 months, allowances for non-melanoma skin cancer)
5. Liver disease
6. Kidney disease
7. Type I diabetes
8. Self-reported history of a major neurological disorder or brain injury resulting in ongoing symptoms or cognitive impairment (e.g., multiple sclerosis, cerebral palsy, major head injury)
9. Self-reported chronic psychotic illness (schizophrenia, bipolar disorder)
10. Lung disease requiring drug treatment (note however that asthma or allergy inhalers are not exclusionary unless they are used on a "regular basis")
4. Pregnant participants, or participants actively planning to become pregnant in the next 3 months, are excluded.
5. Those with a visual impairment that would prevent them from reading printed text or text on a computer screen, iPad, or other electronic device are excluded.
6. Those with color blindness, who may not be able to distinguish colors on some of the tasks used in this study, are excluded.
7. Those who report that they are not comfortable with undergoing MRI because of the confined space would be excluded. If individuals are interested in the study, but unsure about their comfortability with undergoing an MRI, then they would be given the option to try going into a mock MRI, which is a replica of an MRI scanner. This is meant to aid interested individuals in determining whether they are comfortable with having an MRI. If they report that they are comfortable after this experience, then they would be eligible to continue. If not, then they would be discontinued from further participation.
8. Those who use certain medical devices, implants, or other metal objects in or on the body that cannot be removed and are incompatible with use of fMRI (for example, tattooed eyeliner) are excluded. Many devices can be deemed MRI compatible with the make and model of medical device. If a participant reports a metal medical device, a letter from a medical professional with the make and model number of the device may be used to assess compatibility.
9. Those who are unable to fit into an MRI scanner (over 7ft2in tall or greater than 350lbs weight) are excluded.
10. Those who report working the night shift on a frequent basis (half or more of the hours worked in a full workday are between midnight and 8 am, and this has occurred more than 12 times during the past year) are excluded.

Contacts and Locations

Study Contact

Thomas E Kraynak, PhD

CONTACT

412-246-6361

tekraynak@pitt.edu

Principal Investigator

Thomas E Kraynak, PhD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

Thomas E Kraynak, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

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 Date2025-04-09

Study Completion Date2029-07

Study Record Updates

Study Start Date2025-04-09

Study Completion Date2029-07

Terms related to this study

Keywords Provided by Researchers

stress
emotion
transcranial magnetic stimulation
TMS
functional Magnetic Resonance Imaging
fMRI
neuromodulation
cardiovascular

Additional Relevant MeSH Terms

Healthy
Anxiety