Ignite Creation Date:
2024-05-06 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03027414
Status:
COMPLETED
Last Update Posted:
2022-05-17
First Post:
2017-01-18
Brief Title:
Effect of Transcranial Magnetic Stimulation to the Frontoparietal Attention Network on Anxiety Potentiated Startle
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Effect of Transcranial Magnetic Stimulation to the Frontoparietal Attention Network on Anxiety Potentiated Startle
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
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
Objective
To see how TMS affects fear and anxiety through memory and attention tasks
Eligibility
Healthy people ages 18-50 who are right-handed
Design
Participants will be screened through another protocol
Participants in the pilot study will have 1 visit This includes
Urine tests
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
Urine tests
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
TMS
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
Objective
To see how TMS affects fear and anxiety through memory and attention tasks
Eligibility
Healthy people ages 18-50 who are right-handed
Design
Participants will be screened through another protocol
Participants in the pilot study will have 1 visit This includes
Urine tests
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
Urine tests
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
TMS
Detailed Description:
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 Substudies 1 and 3 and 2 Working memory WM related anxiety downregulation while performing the Sternberg WM task under threat of shock Substudy 2
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 anxiety-potentiated 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 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 anxiety-potentiated 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 17-M-0042 | None | None | None |