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Clinical Trials/NCT06603064
NCT06603064
Recruiting
N/A

Neuromodulation of Brain and Emotional Responses to Psychological Stress

University of Pittsburgh1 site in 1 country55 target enrollmentApril 9, 2025
ConditionsHealthyAnxiety

Overview

Phase
N/A
Intervention
Not specified
Conditions
Healthy
Sponsor
University of Pittsburgh
Enrollment
55
Locations
1
Primary Endpoint
Dorsal anterior cingulate cortex activation to stress
Status
Recruiting
Last Updated
12 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 9, 2025
End Date
July 2029
Last Updated
12 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thomas Kraynak

Postdoctoral Fellow

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Medication Use
  • 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.
  • Chemotherapy
  • Immunosuppressants and related biological agents (Imuran, methotrexate, and cyclophosphamide)

Outcomes

Primary Outcomes

Dorsal anterior cingulate cortex activation to stress

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.

Dorsal anterior cingulate cortex connectivity to stress

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.

Change in arousal during stress

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.

Change in valence during stress

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.

Change in perceived control during stress

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.

Systolic blood pressure response to stress

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.

Heart rate response to stress

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.

Secondary Outcomes

  • Dorsal anterior cingulate cortex (dACC) resting cerebral blood flow (rCBF)(30-60 mins post-stimulation)
  • Positive and Negative Affect Schedule - Expanded Form (PANAS-X)(30-60 mins post-stimulation)

Study Sites (1)

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