rTMS Pilot for Anxiety

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-19

Study Completion Date

2022-08-01

Brief Summary

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The purpose of this study is to evaluate the safety and tolerability of 1 Hz parietal stimulation in anxiety. Our approach will be to administer 1 week of open-label accelerated 1 Hz parietal rTMS (5 days, 8 sessions/day, 600 pulses/session) and measure the effect of this neuromodulation on APS, and short term memory in a cohort of anxiety GAD patients.

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Detailed Description

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Aims 1 and 2 of this project will be tested using a within-subjects design where anxiety patients will receive a 5-day course of accelerated 1 Hz rTMS (8x session x 600 pulses/session) to the right IPS. In Aim 1, we will test the effects of this stimulation on arousal during the NPU threat task (NPU section). In Aim 2 below, we will test the effects of this stimulation on arousal-related attention control deficits using the VSTM task (VSTM section).

Subjects will undergo 7 study visits spaced over a roughly 3-week period depending upon availability. First, subjects will have a pre-stimulation test visit. On this visit they will undergo the following procedures: 1) motor threshold testing, 2) noise habituation, 3) shock workup 4) NPU task, 5) VSTM task. Then they will have 5 rTMS visits. On these visits, subjects will receive 8 trains of 1 Hz rTMS (600 pulses per train, each separated by \~50 min). Finally, they will have a post-stimulation test visit, which will included the noise habituation, shock workup, NPU task, and VSTM task.

Conditions

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Generalized Anxiety Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Aim 1: Outcome measures. Anxiety potentiated startle (APS) Statistical Analysis. The main analysis will be a paired-sample t-test (pre vs. post stimulation).

Aim 2: Outcome measures. Accuracy and reaction time during the visual short term memory task (VSTM). Statistical Analysis. The main analysis will be a 2 \[stimulation: pre-stimulation vs. post-stimulation\] by 2 \[load: low vs. high\] repeated-measures ANOVA. Safety and Adverse Events

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Pilot arm

Aims 1 and 2 of this project will be tested using a within-subjects design where anxiety patients will receive a 5-day course of accelerated 1 Hz rTMS (8x session x 600 pulses/session) to the right IPS.

Group Type OTHER

Open-label accelerated 1 Hz repetitive transcranial magnetic stimulation

Intervention Type DEVICE

Patients will receive a 5-day course of accelerated 1 Hz rTMS (8x session x 600 pulses/session) to the right intraparietal sulcus. Subjects will receive a continuous train of 1 Hz stimulation. They will receive a total of 600 pulses per train. Trains will be separated by \~50 min rest intervals.

Interventions

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Open-label accelerated 1 Hz repetitive transcranial magnetic stimulation

Patients will receive a 5-day course of accelerated 1 Hz rTMS (8x session x 600 pulses/session) to the right intraparietal sulcus. Subjects will receive a continuous train of 1 Hz stimulation. They will receive a total of 600 pulses per train. Trains will be separated by \~50 min rest intervals.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Meet the DSM-V criteria for an anxiety disorder (i.e. generalized anxiety disorder, social anxiety disorder, panic disorder, etc.)
* 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 (non-anxiety) 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
* Any medical condition that increases risk for TMS
* History of seizure
* History of epilepsy
* Increased risk of seizure for any reason
* Pregnancy, or positive pregnancy test
* Hearing loss

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No