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| ID | Type | Description | Link |
|---|---|---|---|
| K01MH121653 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The study will (1) assess feasibility of a TMS treatment in an underserved population; (2) determine if this TMS treatment protocol improves PTSD symptoms and biological markers of PTSD such as brain functioning and startle responses; (3) define new brain targets for future TMS studies; (4) provide the first data for individual differences, which will help personalize treatment for PTSD patients; (5) improve knowledge of the neurobiology of PTSD and treatment response.
Posttraumatic stress disorder is a psychiatric disorder that can develop in response to a traumatic event, and half of civilians living in inner-city areas with high levels of violence suffer from PTSD. The currently recommended treatment for PTSD is focused on discussing the trauma, but a third to half of patients cannot participate or do not benefit from this treatment, especially individuals with low levels of education or literacy. Therefore, new treatments for PTSD are needed.
The study will (1) assess feasibility of a TMS treatment in an underserved population; (2) determine if this TMS treatment protocol improves PTSD symptoms and biological markers of PTSD such as brain functioning and startle responses; (3) define new brain targets for future TMS studies; (4) provide the first data for individual differences, which will help personalize treatment for PTSD patients; (5) improve knowledge of the neurobiology of PTSD and treatment response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Experimental | TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions. |
|
| Sham Transcranial Magnetic Stimulation (TMS) | Sham Comparator | Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Device | 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of active Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Amygdala Reactivity During Fear Processing Pre- to Post-treatment | Amygdala reactivity during fear processing were assessed by fMRI responses as participants viewed 15 blocks each of fearful face and neutral face stimuli, while amygdala reactivity was measured. The amygdala was separated in the right and left hemispheres. fMRI measures the blood oxygen level-dependent response, a measure of how much more oxygenated blood there is in a certain brain region, which reflects activation of the brain region. A regression model was used to determine the beta value as a measure of brain activity. Across voxels in each region (right amygdala, left amygdala), the beta value for response in the amygdala to Fearful faces and Neutral faces was extracted. | Baseline, day 10 |
| Change in Skin Conductance Response to Trauma Cues Pre- to Post-treatment | Change in skin conductance response to trauma cues pre- to post-treatment was assessed. The mobile skin conductance response was measured in microsiemens when participants described their worst trauma, followed by assessment of their symptoms. A numeric value estimating the skin conductance response was calculated by subtracting the baseline skin conductance reactivity from the reactivity during the trauma description. | Baseline, day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Inhibition-related Activation in the Ventromedial Prefrontal Cortex (vmPFC) Pre- to Post-treatment | Change in inhibition-related activation in the vmPFC was assessed by fMRI responses as participants viewed 15 blocks each of fearful face and neutral face stimuli. At the same time, reactivity in the ventromedial prefrontal cortex was measured. Across voxels in the ventromedial prefrontal cortex, a contrast estimate of responses to Fearful > Neutral faces was extracted. This is being reported as a numeric value estimating inhibition-related brain activation (contrast estimate fear versus neutral) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanne van Rooij, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Hospital | Atlanta | Georgia | 30322 | United States |
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After confirming eligibility (≥3 DSM-5 PTSD criteria using CAPS-5), 5 participants were excluded for not meeting PTSD criteria, 1 for Bipolar I on diagnostic assessment, and 2 for neurological exclusions. Additionally, 5 participants withdrew before randomization. A total of 50 participants were randomized to active or sham TMS.
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| ID | Title | Description |
|---|---|---|
| FG000 | Transcranial Magnetic Stimulation (TMS) | TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions. Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of active Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions. |
| FG001 | Sham Transcranial Magnetic Stimulation (TMS) | Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted. Sham Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Transcranial Magnetic Stimulation (TMS) | TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions. Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of active Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Amygdala Reactivity During Fear Processing Pre- to Post-treatment | Amygdala reactivity during fear processing were assessed by fMRI responses as participants viewed 15 blocks each of fearful face and neutral face stimuli, while amygdala reactivity was measured. The amygdala was separated in the right and left hemispheres. fMRI measures the blood oxygen level-dependent response, a measure of how much more oxygenated blood there is in a certain brain region, which reflects activation of the brain region. A regression model was used to determine the beta value as a measure of brain activity. Across voxels in each region (right amygdala, left amygdala), the beta value for response in the amygdala to Fearful faces and Neutral faces was extracted. | Posted | Mean | Standard Deviation | BOLD signal | Baseline, day 10 |
|
Data was collected from Baseline to Day 10th of the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transcranial Magnetic Stimulation (TMS) | TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions. Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of active Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headaches (non migraine) | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sanne van Rooij | Emory University | 404-251-8926 | sanne.van.rooij@emory.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 14, 2024 | Apr 6, 2026 | Prot_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 28, 2025 | Jun 16, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Sham Transcranial Magnetic Stimulation (TMS) | Procedure | 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control. |
|
| Baseline, day 10 |
| Change in Inhibition-related Activation in the Hippocampus Pre- to Post-treatment | Change in inhibition-related activation in the hippocampus was assessed by fMRI responses as participants viewed 15 blocks each of fearful face and neutral face stimuli, while hippocampal reactivity was measured. The hippocampus was separated into the right and left hemispheres. Across voxels in each region (right hippocampus, left hippocampus), a contrast estimate of Fearful > Neutral faces was extracted. | Baseline, day 10 |
| Change in Ventromedial Prefrontal Cortex (vmPFC)-Amygdala Functional Connectivity Pre- to Post-treatment | Change in vmPFC-amygdala functional connectivity pre- to post-treatment was assessed. A numeric value estimating the correlation between the vmPFC and amygdala was measured. | Baseline, day 10 |
| Change in Dorsolateral Prefrontal Cortex (DLPFC)-Amygdala Functional Connectivity Pre- to Post-treatment | Change in DLPFC-amygdala functional connectivity pre- to post-treatment was assessed. A numeric value estimating the correlation between the DLPFC and amygdala was measured. | Baseline, day 10 |
| Change in Fear-Potentiated Startle Responses to Danger and Safety Cues Pre- to Post-treatment. | Change in Fear-Potentiated Startle Responses to danger and safety cues pre- to post-treatment was assessed. An eye blink response was measured using electromyography with sensors placed near the eyes. Symbols were presented on a screen, one symbol followed by an airblast to the throat was the danger cue and a different symbol not followed by the airblast was the safety cue. The eye blink response in response to danger and safety cues was measured. | Baseline, day 10 (Post TMS) |
| Change in Discrimination Between Danger and Safety Cues Pre- to Post-treatment | Change in discrimination between danger and safety cues pre- to post-treatment was assessed. An eye blink response was measured using electromyography with sensors placed near the eyes. Symbols were presented on a screen, with one symbol followed by an airblast to the throat serving as the danger cue, and a different symbol, not followed by the airblast, serving as the safety cue. The eye blink response in response to danger and safety cues was measured. The difference score for the eye blink response to danger and safety was calculated. | Baseline, day 10 |
| Change in Post-traumatic Stress Disorder (PTSD) Hyperarousal Symptoms Pre- to Post-treatment | The severity of self-reported PTSD hyperarousal symptoms was assessed with the PCL-5, sub-cluster E. The PCL-5 asks participants to recall the worst stressful event that is currently bothering them the most. Keeping this event in mind, participants respond to 20 questions indicating how bothered they have been by PTSD symptoms. Responses are on a 5-point scale, where 0 = not bothered at all and 4 = extremely bothered. The 6 questions related to hyperarousal were used. Total raw scores range from 0 to 24, where higher scores indicate greater distress from PTSD hyperarousal symptoms. | Baseline, day 10 |
| BG001 | Sham Transcranial Magnetic Stimulation (TMS) | Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted. Sham Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Sham Transcranial Magnetic Stimulation (TMS) | Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted. Sham Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control. |
|
|
| Primary | Change in Skin Conductance Response to Trauma Cues Pre- to Post-treatment | Change in skin conductance response to trauma cues pre- to post-treatment was assessed. The mobile skin conductance response was measured in microsiemens when participants described their worst trauma, followed by assessment of their symptoms. A numeric value estimating the skin conductance response was calculated by subtracting the baseline skin conductance reactivity from the reactivity during the trauma description. | A technical issue with the recording system-specifically, electrical noise-resulted in unusable recordings for one timepoint. | Posted | Mean | Standard Deviation | microsiemens | Baseline, day 10 |
|
|
|
| Secondary | Change in Inhibition-related Activation in the Ventromedial Prefrontal Cortex (vmPFC) Pre- to Post-treatment | Change in inhibition-related activation in the vmPFC was assessed by fMRI responses as participants viewed 15 blocks each of fearful face and neutral face stimuli. At the same time, reactivity in the ventromedial prefrontal cortex was measured. Across voxels in the ventromedial prefrontal cortex, a contrast estimate of responses to Fearful > Neutral faces was extracted. This is being reported as a numeric value estimating inhibition-related brain activation (contrast estimate fear versus neutral) | Posted | Mean | Standard Deviation | BOLD signal difference | Baseline, day 10 |
|
|
|
| Secondary | Change in Inhibition-related Activation in the Hippocampus Pre- to Post-treatment | Change in inhibition-related activation in the hippocampus was assessed by fMRI responses as participants viewed 15 blocks each of fearful face and neutral face stimuli, while hippocampal reactivity was measured. The hippocampus was separated into the right and left hemispheres. Across voxels in each region (right hippocampus, left hippocampus), a contrast estimate of Fearful > Neutral faces was extracted. | Posted | Mean | Standard Deviation | BOLD signal difference | Baseline, day 10 |
|
|
|
| Secondary | Change in Ventromedial Prefrontal Cortex (vmPFC)-Amygdala Functional Connectivity Pre- to Post-treatment | Change in vmPFC-amygdala functional connectivity pre- to post-treatment was assessed. A numeric value estimating the correlation between the vmPFC and amygdala was measured. | Posted | Mean | Standard Deviation | correlation coefficient | Baseline, day 10 |
|
|
|
| Secondary | Change in Dorsolateral Prefrontal Cortex (DLPFC)-Amygdala Functional Connectivity Pre- to Post-treatment | Change in DLPFC-amygdala functional connectivity pre- to post-treatment was assessed. A numeric value estimating the correlation between the DLPFC and amygdala was measured. | Posted | Mean | Standard Deviation | correlation coefficient | Baseline, day 10 |
|
|
|
| Secondary | Change in Fear-Potentiated Startle Responses to Danger and Safety Cues Pre- to Post-treatment. | Change in Fear-Potentiated Startle Responses to danger and safety cues pre- to post-treatment was assessed. An eye blink response was measured using electromyography with sensors placed near the eyes. Symbols were presented on a screen, one symbol followed by an airblast to the throat was the danger cue and a different symbol not followed by the airblast was the safety cue. The eye blink response in response to danger and safety cues was measured. | One participant in the Sham group could not tolerate it, and for the rest of the missing participants, the equipment malfunctioned. Therefore, the data on these participants was not collected. | Posted | Mean | Standard Deviation | microvolt | Baseline, day 10 (Post TMS) |
|
|
|
| Secondary | Change in Discrimination Between Danger and Safety Cues Pre- to Post-treatment | Change in discrimination between danger and safety cues pre- to post-treatment was assessed. An eye blink response was measured using electromyography with sensors placed near the eyes. Symbols were presented on a screen, with one symbol followed by an airblast to the throat serving as the danger cue, and a different symbol, not followed by the airblast, serving as the safety cue. The eye blink response in response to danger and safety cues was measured. The difference score for the eye blink response to danger and safety was calculated. | One participant in the Sham group could not tolerate it, and for the rest of the missing participants, the equipment malfunctioned. Therefore, the data on these participants was not collected. | Posted | Mean | Standard Deviation | microvolt | Baseline, day 10 |
|
|
|
| Secondary | Change in Post-traumatic Stress Disorder (PTSD) Hyperarousal Symptoms Pre- to Post-treatment | The severity of self-reported PTSD hyperarousal symptoms was assessed with the PCL-5, sub-cluster E. The PCL-5 asks participants to recall the worst stressful event that is currently bothering them the most. Keeping this event in mind, participants respond to 20 questions indicating how bothered they have been by PTSD symptoms. Responses are on a 5-point scale, where 0 = not bothered at all and 4 = extremely bothered. The 6 questions related to hyperarousal were used. Total raw scores range from 0 to 24, where higher scores indicate greater distress from PTSD hyperarousal symptoms. | Posted | Mean | Standard Deviation | score on a scale | Baseline, day 10 |
|
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|
| 0 |
| 26 |
| 0 |
| 26 |
| 7 |
| 26 |
| EG001 | Sham Transcranial Magnetic Stimulation (TMS) | Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted. Sham Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control. | 0 | 24 | 0 | 24 | 4 | 24 |
| Fatigue | General disorders | Non-systematic Assessment |
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| Reduced sleep | General disorders | Non-systematic Assessment |
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| Nausea | General disorders | Non-systematic Assessment |
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| Balance difficulty | Nervous system disorders | Non-systematic Assessment |
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| Light headedness | General disorders | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Flu | Infections and infestations | Non-systematic Assessment |
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| Tonsilitis | Ear and labyrinth disorders | Non-systematic Assessment |
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| Muscle tension | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Electrical Shock sensation | Nervous system disorders | Non-systematic Assessment |
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| Difficulty swalloing | Gastrointestinal disorders | Non-systematic Assessment |
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| Hips "burning" | General disorders | Non-systematic Assessment |
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| Nose bleeds | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Abdominal surgery (Hernia) | General disorders | Non-systematic Assessment |
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| Bronchitis with pneumonia | Infections and infestations | Non-systematic Assessment |
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| Eye twitch | General disorders | Non-systematic Assessment |
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| Rash on head and face | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Lupus | Immune system disorders | Non-systematic Assessment |
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| Heart pounding | Cardiac disorders | Non-systematic Assessment |
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| Muscle twitches (triceps) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Numbness and tingling sensation | General disorders | Non-systematic Assessment |
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| Decreased appetite | General disorders | Non-systematic Assessment |
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| Panic attack | Psychiatric disorders | Non-systematic Assessment |
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| Legs "burning" | General disorders | Non-systematic Assessment |
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| Hand Spasm | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Weight loss | General disorders | Non-systematic Assessment |
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| Wrist sprain | General disorders | Non-systematic Assessment |
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| Finger fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Migraines | Nervous system disorders | Non-systematic Assessment |
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| Car accident | General disorders | Non-systematic Assessment |
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| Cold sore | General disorders | Non-systematic Assessment |
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| Eye pain | Eye disorders | Non-systematic Assessment |
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| Nerve pain | Nervous system disorders | Non-systematic Assessment |
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| Restlessness | General disorders | Non-systematic Assessment |
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| Joint pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Rheumatoid Arthritis flare up | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Increased anxiety | General disorders | Non-systematic Assessment |
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| Worsening depression | Psychiatric disorders | Non-systematic Assessment |
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| Increased sensitivity | General disorders | Non-systematic Assessment |
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| Irritability | General disorders | Non-systematic Assessment |
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| Increased stress | Psychiatric disorders | Non-systematic Assessment |
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| Nightmares | Psychiatric disorders | Non-systematic Assessment |
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| Increased emotional reactivity | Psychiatric disorders | Non-systematic Assessment |
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| Feeling overwhelmed | General disorders | Non-systematic Assessment |
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| Increased dissociation | Psychiatric disorders | Non-systematic Assessment |
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| Mental fogginess | General disorders | Non-systematic Assessment |
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| Emotional burnout | General disorders | Non-systematic Assessment |
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| Flashbacks | Psychiatric disorders | Non-systematic Assessment |
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| Worsening affect | General disorders | Non-systematic Assessment |
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| Nighttime hallucinations | Psychiatric disorders | Non-systematic Assessment |
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| Racing thoughts/ Rumination | Psychiatric disorders | Non-systematic Assessment |
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| Panic attack (psychological symptoms) | Psychiatric disorders | Non-systematic Assessment |
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| Paranoia | Psychiatric disorders | Non-systematic Assessment |
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| Disorientation | Psychiatric disorders | Non-systematic Assessment |
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| Increased impulsivity | Psychiatric disorders | Non-systematic Assessment |
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| Pessimism | Psychiatric disorders | Non-systematic Assessment |
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| Disordered eating behaviors (binging & purging) | Psychiatric disorders | Non-systematic Assessment |
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| Post TMS (Day 10) |
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| Post TMS (day 10): Right |
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| Post TMS (day 10): Left |
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| Baseline :Safety |
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| Post TMS (Day 10): Danger |
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| Post TMS (Day 10): Safety |
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| Post TMS (Day 10) |
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