Effect of Transcranial Magnetic Stimulation to the Frontoparietal Attention Network on Anxiety Potentiated Startle
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|ClinicalTrials.gov Identifier: NCT03027414|
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : January 7, 2019
Researchers want to better understand brain processes related to fear and anxiety. They want to find out if transcranial magnetic stimulation (TMS), a type of brain stimulation, can reduce anxiety.
To see how TMS affects fear and anxiety through memory and attention tasks.
Healthy people ages 18-50 who are right-handed
Participants will be screened through another protocol.
Participants in the pilot study will have 1 visit. This includes:
Questionnaires about mood and thinking
Shock and startle workup: Electrodes are taped to the wrists or fingers. Participants will be shocked to find out what level of shock is uncomfortable but tolerable. They will hear loud, sudden noises through headphones.
TMS: A coil is held on the scalp. A magnetic field stimulates the brain. Sometimes they might receive fake TMS. This feels the same as real TMS. They will perform simple tasks. Participants in the main study will have 2 visits within 2 weeks.
The first visit includes:
Questionnaires about mood and thinking
MRI: Participants lie on a table that slides into a scanner. They will be in the scanner about 1 hour. A computer screen in the scanner will tell them to perform simple tasks.
The second visit includes:
Shock and startle workup
|Condition or disease|
Objective: To determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects. Toward this aim we will test the effect of transcranial magnetic stimulation (TMS) on two outcome measures: 1) Fear and anxiety during the threat of predictable and unpredictable shock (NPU threat test), and 2) Working memory (WM) related anxiety downregulation while performing the Sternberg WM task under threat of shock.
Study population: The study population will consist of up to 184 healthy volunteers between the ages of 18-50.
Design: This study will consists of two (sub-studies 1 and 2) or three (sub-study 3) outpatient visits (1 MRI, 1 or 2 TMS visits [2 for sub-study 3]). In this protocol we will explore the effect of TMS in three sub-studies in the TMS study visit. The sub-studies will contain either the NPU or the Sternberg task during the TMS visits. The first visit (MRI) will consist of the same procedures for all sub-studies. Each subject will be assigned to only one of the sub-studies.
Sternberg Task: Expose subjects to active or sham TMS to a region of the frontoparietal attention network during the Sternberg WM task. Subjects will have to maintain a series of letters in WM for a brief interval during blocks of safety and threat of shock.
NPU Task: Expose subjects to active or sham TMS to a region of the frontoparietal attention network during the NPU threat test. Subjects will be exposed to blocks in which they are either 1) safe from shock (neutral), 2) at risk of shock delivered only during a cue (predictable), or 3) at risk of shock presented randomly (unpredictable).
Outcome measures: In both studies the primary outcome measure will be anxietypotentiated startle (APS), which is the increase in startle magnitude during periods of threat compared to periods of safety. We expect active, but not sham TMS to increase activity in the dlPFC, and therefore reduce APS in both studies
|Study Type :||Observational|
|Estimated Enrollment :||184 participants|
|Official Title:||The Effect of Transcranial Magnetic Stimulation to the Frontoparietal Attention Network on Anxiety Potentiated Startle|
|Study Start Date :||January 12, 2017|
|Estimated Primary Completion Date :||November 30, 2025|
|Estimated Study Completion Date :||November 30, 2025|
- The primary objective of this study is to determine whether strengthening activity in the dlPFC with TMS will reduce anxiety either alone (during NPU) or during a low load cognitive task(Sternberg WM). [ Time Frame: 3 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027414
|Contact: Deborah Roberts, Ph.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Christian Grillon, Ph.D.||National Institute of Mental Health (NIMH)|