University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Location status: Recruiting
Location contact
Jacob White
CONTACT
Natasha Brinkley
CONTACT
Thomas E Kraynak, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06603064
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.
Interested in participating?
Request Info30 year–50 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15213, United States
Location status: Recruiting
Jacob White
CONTACT
Natasha Brinkley
CONTACT
Thomas E Kraynak, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
a. 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: i. 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) ii. Anticonvulsant medications iii. Anti-Parkinson medications iv. Protease inhibitors or other Anti-HIV medications v. Medications for the treatment of mania, including antipsychotics vi. All other centrally active or psychotropic medications (e.g., stimulants), excluding anxiolytic and antidepressant medications (see 1.b).
vii. Insulin viii. Chemotherapy ix. Immunosuppressants and related biological agents (Imuran, methotrexate, and cyclophosphamide) x. Prescription weight loss medications and ephedrine OTC b. 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: i. Short-lasting benzodiazepines ii. Asthma oral medications iii. Asthma/allergy inhalants iv. Glucocorticoids (e.g., oral prednisone, cortisol) v. Medical marijuana c. 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: i. Longer acting benzodiazepines ii. Sleep medications (e.g., trazodone) d. 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.
e. 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.
This intervention involves an active form of continuous theta burst stimulation (cTBS) that will be targeted to the dorsal anterior cingulate cortex based on neural navigation software. cTBS will be delivered in one session, lasting a few minutes, before participants complete additional testing.
This intervention involves an sham form of continuous theta burst stimulation (cTBS) that will be targeted to the dorsal anterior cingulate cortex based on neural navigation software. cTBS will be delivered in one session, lasting a few minutes, before participants complete additional testing.
Time frame: 30-60 mins post-stimulation
Blood-oxygen-level-dependent (BOLD) signal in a dorsal anterior cingulate cortex (dACC) region of interest mask extracted from the incongruent (stress) vs congruent (control) contrast.
Time frame: 30-60 mins post-stimulation
Generalized psychophysiological interaction (gPPI) estimate reflecting stressor-evoked dorsal anterior cingulate cortex (dACC) functional connectivity to the anterior insula, amygdala, and periaqueductal gray.
Time frame: 30-60 mins post-stimulation
Rating on a modified self-assessment manikin scale (SAM) measuring subjective ratings of arousal ("To what extent do you feel calm?" 1 - very calm, 9 - very aroused) following the psychological stressor task compared to a pre-stressor baseline.
Time frame: 30-60 mins post-stimulation
Rating on a modified self-assessment manikin scale (SAM) measuring subjective ratings of valence ("To what extent do you feel happy vs unhappy?" 1 - very unhappy, 9 - very unhappy) following the psychological stressor task compared to a pre-stressor baseline.
Time frame: 30-60 mins post-stimulation
Rating on a modified self-assessment manikin scale (SAM) measuring subjective ratings of perceived control ("To what extent do you feel in control?" 1 - very little control, 9 - very much control) following the psychological stressor task compared to a pre-stressor baseline.
Time frame: 30-60 mins post-stimulation
The difference in systolic blood pressure (in mmHg) obtained during the psychological stress task compared to a resting pre-stressor period.
Time frame: 30-60 mins post-stimulation
The difference in heart rate (in beats per minute) obtained during the psychological stress task compared to a resting pre-stressor period.
Time frame: 30-60 mins post-stimulation
Cerebral blood flow (in mL/g/min) obtained at rest within a dorsal anterior cingulate cortex (dACC) region of interest.
Time frame: 30-60 mins post-stimulation
Contact information is provided by the study sponsor or research team.
University of Pittsburgh
Other
Acronym: NUMBER
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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