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HealthyNUMBERNCT06603064

Neuromodulation of Brain and Emotional Responses to Psychological Stress

A study testing Active continuous theta burst stimulation in people with Healthy and Anxiety, run by University of Pittsburgh at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Anxiety
What is being tested?
Active continuous theta burst stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
55 participants
Where
1 siteUnited States
Study dates
9 Apr 2025to Jul 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult
  1. Medication Use
  2. 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.
  3. 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.
  4. Substance use exclusions:
  5. Anyone reporting 35 or more alcoholic drinks in the last 7 days is excluded.
  6. Anyone reporting consumption of 6 or more alcoholic drinks on 3 or more occasions in the past 7 days is excluded.
  7. Anyone reporting use of illicit drugs on 7 or more days in the past 2 weeks is excluded.
  8. Medical conditions:
  9. Epilepsy or a history of seizures.
  10. Self-reported prior heart attack, stroke, bypass surgery, angioplasty, congestive heart failure, arrhythmia (cardiac rhythm problems).
  11. Severe hypertension (SBP/DBP > 160/and/or >100 mmHg)
  12. Cancer (treatment in last 12 months, allowances for non-melanoma skin cancer)
  13. Liver disease
  14. Kidney disease
  15. Type I diabetes
  16. 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)
  17. Self-reported chronic psychotic illness (schizophrenia, bipolar disorder)
  18. Lung disease requiring drug treatment (note however that asthma or allergy inhalers are not exclusionary unless they are used on a "regular basis")
  19. Pregnant participants, or participants actively planning to become pregnant in the next 3 months, are excluded.
  20. 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.
  21. Those with color blindness, who may not be able to distinguish colors on some of the tasks used in this study, are excluded.
  22. 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.
  23. 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.
  24. Those who are unable to fit into an MRI scanner (over 7ft2in tall or greater than 350lbs weight) are excluded.
  25. 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.
  26. Those who report undergoing brain stimulation procedures (including transcranial magnetic stimulation, transcranial direct current stimulation, vagus nerve stimulation, or transcranial ultrasound stimulation) as part of research or therapy in the past month are excluded.
  27. Lifetime history of a suicide attempt, or suicidal ideation within the past year.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Thomas E Kraynak, PhD contact

412-246-6361

tekraynak@pitt.edu

United States1 site, 1 recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

    Jacob White, 412-290-1097, whitej32@upmc.edu

    Natasha Brinkley, 412-551-9163, brinkleynd@upmc.edu

    Recruiting

Other trials in United States

About this study

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.

Conditions
Healthy, Anxiety
Being tested
Active continuous theta burst stimulation, Sham continuous theta burst stimulation
Keywords
stress, emotion, transcranial magnetic stimulation, TMS, functional Magnetic Resonance Imaging, fMRI, neuromodulation, cardiovascular
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active continuous theta burst stimulationDevice

    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.

  • Sham continuous theta burst stimulationDevice

    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.

Study groups in NCT06603064
Study groupRoleWhat they receive
Active then ShamExperimentalIn this arm, participants will first undergo active theta burst stimulation (cTBS) at the first visit and then undergo sham cTBS in the second visit.
Receives: Device: Active continuous theta burst stimulation; Device: Sham continuous theta burst stimulation
Sham then ActiveExperimentalIn this arm, participants will first undergo sham theta burst stimulation (cTBS) at the first visit and then undergo active cTBS in the second visit.
Receives: Device: Active continuous theta burst stimulation; Device: Sham continuous theta burst stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dorsal anterior cingulate cortex activation to stress

    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.

    Measured: 30-60 mins post-stimulation

  2. Dorsal anterior cingulate cortex connectivity to stress

    Generalized psychophysiological interaction (gPPI) estimate reflecting stressor-evoked dorsal anterior cingulate cortex (dACC) functional connectivity to the anterior insula, amygdala, and periaqueductal gray.

    Measured: 30-60 mins post-stimulation

  3. Change in arousal during stress

    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.

    Measured: 30-60 mins post-stimulation

  4. Change in valence during stress

    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.

    Measured: 30-60 mins post-stimulation

  5. Change in perceived control during stress

    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.

    Measured: 30-60 mins post-stimulation

  6. Systolic blood pressure response to stress

    The difference in systolic blood pressure (in mmHg) obtained during the psychological stress task compared to a resting pre-stressor period.

    Measured: 30-60 mins post-stimulation

  7. Heart rate response to stress

    The difference in heart rate (in beats per minute) obtained during the psychological stress task compared to a resting pre-stressor period.

    Measured: 30-60 mins post-stimulation

Secondary outcomes (2)

  1. Dorsal anterior cingulate cortex (dACC) resting cerebral blood flow (rCBF)

    Cerebral blood flow (in mL/g/min) obtained at rest within a dorsal anterior cingulate cortex (dACC) region of interest.

    Measured: 30-60 mins post-stimulation

  2. Positive and Negative Affect Schedule - Expanded Form (PANAS-X)

    Measured: 30-60 mins post-stimulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start9 Apr 2025
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
This study will use a within-subject crossover design involving an \'active\' TMS arm and a \'sham\' (placebo) TMS arm. Each arm involves one visit (approx 2 hours each). Participants will complete both arms of the design.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06603064
Sponsor's protocol ID
STUDY24020114
Other IDs
K01MH137517
Acronym
NUMBER
Status last verified
May 2026
First submitted
16 Sep 2024
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will comply with all National Institute of Mental Health (NIMH) guidelines regarding data sharing and make use of NIMH databases.

Questions about this trial

What is this clinical trial studying?

A study testing Active continuous theta burst stimulation in people with Healthy and Anxiety, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Thomas E Kraynak, PhD (412-246-6361, tekraynak@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dorsal anterior cingulate cortex activation to stress (time frame: 30-60 mins post-stimulation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06603064.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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