Anxiety Clinical Trial
Official title:
Examining the Mechanisms of Anxiety Regulation Using a Novel, Sham-controlled, fMRI-guided rTMS Protocol and a Translational Laboratory Model of Anxiety
Verified date | September 2023 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Given the overall lack of treatment adherence/efficacy, side effects of drugs, and the substantial burden of anxiety disorders on the individual and on the national healthcare system, there is a critical need for mechanistic research into the CNS mechanisms that underlie these disorders. Accordingly, the objective of this grant is to use noninvasive neuromodulation to causally identify the key neural mechanisms that mediate the cognitive symptoms of anxiety. This project is relevant to public health because it has the potential to lead to novel repetitive transcranial magnetic stimulation treatments for pathological anxiety.
Status | Active, not recruiting |
Enrollment | 63 |
Est. completion date | August 1, 2024 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Subjects must be 18-50 years old - Able to give their consent - Right-handed Exclusion Criteria: - Non-english speaking - Any significant medical or neurological problems - Current or past Axis I psychiatric disorder(s), active or history of active suicidal ideation - Alcohol/drug problems in the past year or lifetime alcohol or drug dependence - Medications that act on the central nervous system - History of seizure - History of epilepsy - Increased risk of seizure for any reason - Pregnancy, or positive pregnancy test - IQ <80 - Any medical condition that increases risk for fMRI or TMS - Any metal in their body which would make having an MRI scan unsafe - Any sort of medical implants - Hearing loss - Claustrophobia |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anxiety Potentiated Startle during NPU | NPU Task: The instructed fear paradigm that will be implemented uses administration of predictable and unpredictable shocks to generate phasic and sustained forms of potentiated startle. The experiment consists of three different conditions: no shock (N), predictable shock (P), and unpredictable shock (U), each lasting approximately 150 sec. In the N condition, no shocks will be delivered. In the P condition, shocks will be administered predictably, that is, only in the presence of a threat cue. In the U condition, the shocks will be unpredictable. In each 150-sec condition, an 8-sec cue will be presented four times. The cue will signal the possibility of receiving a shock only in the P condition. Startle probes will be presented either during the cue period, or the ITI. | 24 Hours | |
Primary | Fear Potentiated Startle during NPU | NPU Task: The instructed fear paradigm that will be implemented uses administration of predictable and unpredictable shocks to generate phasic and sustained forms of potentiated startle. The experiment consists of three different conditions: no shock (N), predictable shock (P), and unpredictable shock (U), each lasting approximately 150 sec. In the N condition, no shocks will be delivered. In the P condition, shocks will be administered predictably, that is, only in the presence of a threat cue. In the U condition, the shocks will be unpredictable. In each 150-sec condition, an 8-sec cue will be presented four times. The cue will signal the possibility of receiving a shock only in the P condition. Startle probes will be presented either during the cue period, or the ITI. | 24 hours | |
Primary | Sternberg WM accuracy | Sternberg task: On each WM trial, subjects will see a series of 4 letters presented singularly (encoding period) that will be followed by a brief interval where subjects are required to maintain these letters (maintenance period). At the end of the maintenance period, subjects will be prompted to make a response based on the task instructions (response period). The response prompt will consist of a letter and a number. The letter will be chosen from the study series, and the number will correspond to a position in the series. The subjects will indicate whether the position of the letter in the series matches the number. | 24 hours | |
Primary | TMS-evoked BOLD responses | As with Experiment 1, subjects will have Neutral, Predictable, and Unpredictable periods. During the neutral periods, they will be safe from shocks. During the predictable periods, they can receive shocks but only when there is a cue present. During the unpredictable periods, they will be at risk for shock during the entire duration of the block. Rather than probing their ongoing fear and anxiety with the startle probes, we will replace the startle probes with single TMS pulses to the right dlPFC. This will allow us to causally examine the effect of right dlPFC activity (induced by the TMS pulse) on the neural activity that mediates fear (during the predictable cue) and anxiety (during the unpredictable cue and ITI). Importantly, by replacing the startle probes with TMS pulses, it will be possible to directly compare the TMS-evoked BOLD responses to the pattern of startle responses collected during the MRI/pre-stimulation visit. | 2 seconds (i.e. Latency of BOLD response) |
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