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Neuromodulation
Brain Stimulation for Stress (NUMBER Trial)
N/A
Waitlist Available
Led By Thomas E Kraynak, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 30 to 50
Be between 18 and 65 years old
Must not have
Use of more than 2 non-insulin medications for diabetes on a regular basis
Regular use of specific medications within the past 14 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30-60 mins post-stimulation
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether using a non-invasive brain stimulation technique will change how people respond to stress. Healthy participants will do tasks in an MRI machine, then receive brain stimulation in two sessions - one
Who is the study for?
This trial is for healthy individuals interested in how brain stimulation might affect their emotional response to stress. Participants should be willing to undergo MRI scans and two sessions of transcranial magnetic stimulation (TMS), one active and one sham.
What is being tested?
The study tests the effects of a non-invasive brain stimulation technique called continuous theta burst stimulation on managing stress and anxiety. It involves comparing active TMS with a placebo-like 'sham' version while participants complete tasks during an MRI scan.
What are the potential side effects?
Side effects from TMS may include discomfort at the stimulation site, headache, lightheadedness, or seizures; however, these are generally rare. The 'sham' procedure has minimal risks as it mimics actual treatment without delivering the stimulus.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 30 and 50 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I regularly take more than 2 non-insulin diabetes medications.
Select...
I have been taking certain medications regularly for the last 14 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30-60 mins post-stimulation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30-60 mins post-stimulation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in arousal during stress
Change in perceived control during stress
Change in valence during stress
+4 moreSecondary study objectives
Dorsal anterior cingulate cortex (dACC) resting cerebral blood flow (rCBF)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Sham then ActiveExperimental Treatment2 Interventions
In this arm, participants will first undergo sham theta burst stimulation (cTBS) at the first visit and then undergo active cTBS in the second visit.
Group II: Active then ShamExperimental Treatment2 Interventions
In this arm, participants will first undergo active theta burst stimulation (cTBS) at the first visit and then undergo sham cTBS in the second visit.
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,789 Previous Clinical Trials
16,359,568 Total Patients Enrolled
25 Trials studying Anxiety
12,928 Patients Enrolled for Anxiety
National Institute of Mental Health (NIMH)NIH
2,928 Previous Clinical Trials
2,744,964 Total Patients Enrolled
91 Trials studying Anxiety
41,939 Patients Enrolled for Anxiety
Thomas E Kraynak, PhDPrincipal InvestigatorUniversity of Pittsburgh