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This study evaluates an accelerated schedule of theta-burst stimulation for depressive symptoms in psychiatric inpatients.
A small pilot study (n=22) will be carried out to demonstrate feasibility, using the FDA-approved stimulation site for depression treatment (L-DLPFC). Participants will be offered stimulation at the anterior cingulate cortex (ACC).
This study intends to investigate whether modifying stimulation parameters enables typical 6-8 week long rTMS protocols to be compressed to only five days. The influence of this accelerated protocol on the length of patient stay in the hospital will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dorsolateral Prefrontal Cortex | Experimental | The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days. |
|
| Anterior Cingulate Cortex | Experimental | The accelerated theta burst stimulation protocol will be applied to the left anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dorsolateral Prefrontal Cortex Accelerated Theta Burst Stimulation | Device | Participants will receive iTBS (intermittent theta burst stimulation) to the left DLPFC. Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth). Stimulation will be delivered using the Brainsway TMS system. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montgomery Asberg Depression Rating Scale (MADRS) Score | A 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Severity gradations for the MADRS have been proposed: 9-17 = mild depression, 18-34 = moderate depression, and ≥ 35 = severe depression. Scores range from 0-60 (higher scores are more symptomatic). Response is defined as a 50% reduction or greater in MADRS score compared to baseline. Remission is defined as a MADRS score of <10. Data are presented as a raw score point change. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Scale of Suicidal Ideation (SSI) Score | 19-item clinician administered assessment to measure the intensity, pervasiveness, and characteristics of suicidal ideation in adults. Scores range from 0-38. Higher scores indicate more suicidality. Data are presented as a raw score point change. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Alcohol Craving Questionnaire Score (Adapted for All Drug Use) | If participants have a co-morbid diagnosis of drug abuse this self-report questionnaire will be used to monitor craving of their particular drug of abuse. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nolan Williams, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Hospital | Palo Alto | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20439832 | Background | George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46. | |
| 8547583 |
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23 participants signed informed consent; 22 participants were allocated to a treatment group.
All participants were recruited from Stanford Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Dorsolateral Prefrontal Cortex | The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days. |
| FG001 | Anterior Cingulate Cortex (ACC) | The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dorsolateral Prefrontal Cortex | The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days. |
| BG001 | Anterior Cingulate Cortex (ACC) |
| 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 Montgomery Asberg Depression Rating Scale (MADRS) Score | A 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Severity gradations for the MADRS have been proposed: 9-17 = mild depression, 18-34 = moderate depression, and ≥ 35 = severe depression. Scores range from 0-60 (higher scores are more symptomatic). Response is defined as a 50% reduction or greater in MADRS score compared to baseline. Remission is defined as a MADRS score of <10. Data are presented as a raw score point change. | Only participants who completed the protocol were included in this analysis. | Posted | Mean | Standard Deviation | score on a scale | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
|
The day after treatment was completed, the participant was asked to complete a questionnaire regarding any adverse events during the week. (If any adverse events were evident to the researcher during the treatment week, a note was made and this was included in the final assessment to prevent under reporting of side-effects if the participant forgot about these events by the end of the 5 day treatment).
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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 | Dorsolateral Prefrontal Cortex (L-DLPFC) | The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC) Accelerated theta burst stimulation: All participants will receive iTBS (intermittent theta burst stimulation) to the left DLPFC (if participants do not respond to L-DLPFC stimulation, they may be offered stimulation at the ACC). Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth). Stimulation will be delivered using the Brainsway TMS system. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Self-harm | Psychiatric disorders | Systematic Assessment | Determined not to be related to study participation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Nolan Williams | Stanford University | (650)800-6920 | nolanw@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2018 | Jun 30, 2021 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 10, 2020 | Jul 9, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D013405 | Suicide |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D016728 | Self-Injurious Behavior |
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A small pilot study (n=22) will be an open-label study in which all participants receive stimulation to the L-DLPFC to demonstrate feasibility of delivering this accelerated protocol on an inpatient unit.
For participants who do not respond to L-DLPFC stimulation, we will offer an alternative site, the ACC.
If patients are enrolled that have a psychiatric diagnosis other than MDD, scales measuring symptoms related to their other diagnosis/(es) will also be collected in addition to measuring change in depressive symptoms (see 'other pre-specified outcome measures' for a list of measures used to measure symptoms related to psychiatric diagnoses other than depression).
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|
| Anterior Cingulate Cortex Accelerated Theta Burst Stimulation | Device | Participants will receive iTBS (intermittent theta burst stimulation) to the anterior cingulate cortex (ACC). Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth). Stimulation will be delivered using the Brainsway TMS system. |
|
| Change in Hamilton Rating Scale for Depression Six Item (HAMD-6) Score | Clinical assessment measuring depressive symptoms. Scores range from 0-24 with scores >5 indicating clinical levels of depressive symptoms (higher scores are more symptomatic). Data are presented as a raw score point change. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in Young Mania Rating Scale (YMRS) | The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Typical YMRS baseline scores can vary a lot. They depend on the patients' clinical features such as mania (YMRS = 12), depression (YMRS = 3), or euthymia (YMRS = 2). Data are presented as a raw score point change. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in Beck Depression Inventory II (BDI-II) | The Beck Depression Inventory (BDI-II) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. Scores: 0-13= minimal depression, 14-19=mild depression, 20-28=moderate depression, 29-63=severe depression. Data are presented as a raw score point change. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in Quick Inventory Depressive Scale-Self Reported (QIDS) Score | Self-report measure of depressive symptoms. The questionnaire consists of 16 questions. Each question can score between 0 to 4 points. Severity of depression is determined as follows: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Very Severe. Total scores range from 0-27. Total scores: 0-5= no depression, 6-10= mild depression, 11-15= moderate depression, 16-20= severe depression, 21-27= very severe depression. The total score is obtained by adding the scores for each of the nine symptom domains of the DSM-IV MDD criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes (Rush et al. 2003). Data are presented as a raw score point change. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS-20) Score | Self-report, 20 item scale to determine patient's insomnia level. Each question can be scored between 0-3. 0=not bothered at all slightly bothered moderately bothered severely bothered Total score is calculated by adding up all questions (i.e. Q1+Q2+...Q20). One missing item is allowed, pro-rate if missing one item....i.e. (sum/count)*20. Minimum Score = 0 (good); Maximum Score = 60 (bad). Data are presented as a raw score point change. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in Resting-state Recordings and TMS-evoked Potentials in EEG Data. | For the first and last stimulation session, EEG recording will be made before (resting-state EEG) and during (TMS-evoked potentials) the stimulation. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Biomarker Analysis in Patient Blood (Plasma) Samples | Blood (plasma) samples will be collected before and one month after stimulation. Blood collection is conducted by the registered hospital phlebotomist (following same protocol of a routine blood test). Blood samples will be analyzed by our collaborators at the Open Medicine Institute. Specifically, samples will be used for DNA/RNA extraction and analyses will be done to determine potential gene targets. Presence of inflammatory markers (cytokines) will also be determined. All analyses of blood samples will be conducted in the Open Medicine Institute. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Biomarker Analysis in Patient Stool Samples | Stool samples will be collected before and one month after stimulation. Stool collection is performed by registered hospital nurses. Stool samples will be analyzed by our collaborators at the Open Medicine Institute. Specifically, stool samples will be analyzed for potential biomarkers in the gut microbiome. All analyses of stool samples will be conducted in the Open Medicine Institute. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Biomarker Analysis in Patient Saliva Samples | Saliva samples will be collected before and one month after stimulation. Saliva collection is performed by registered study personnel. Saliva samples will be analyzed by our collaborators at the Open Medicine Institute. Specifically, saliva samples will be analyzed for cortisol levels. All analyses of stool samples will be conducted in the Open Medicine Institute. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in th Quality of Life Enjoyment and Satisfaction Questionnaire-short Form Score | 15-item self-report questionnaire where each item is scored from very poor=1 to very good=5. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are stand-alone items. The raw total score ranges from 14 (min) to 70 (max). | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in Performance on the NIH Toolbox | Neurocognitive assessments delivered through an iPad app | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in Immediate Mood Scaler (Ims-12) Depression Subscale Score | Immediate Mood Scaler (IMS) is a newly developed, iPad-deliverable 12-item self-report tool designed to capture current mood states with overall score, and depression and anxiety subscales. Individual item scores range from 1-7, with a total overall score range from 12-84. Data are presented as a raw score point change in depression subscale score. The depression subscale scores range from 7-49 (higher score indicating worse depression). | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in Heart Rate Variability | Measure presence of any change in heart rate variability. Data is reported as a ratio of low frequency (LF) and high frequency (HF) (LF/HF FFT). FFT: fast Fourier transform. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in Borderline Evaluation Of Severity Over Time (BEST) Score |
If participants have a co-morbid diagnosis of borderline personality disorder this self-report questionnaire will be used to monitor symptoms. |
| After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in Obsessive Compulsive Drinking Scale Score (Adapted for Use of Any Drug) | If participants have a co-morbid diagnosis of drug abuse this self-report questionnaire will be used. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in Average Weekly Substance Use | If participants have a co-morbid diagnosis of drug abuse their reported average weekly substance use will be recorded. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in Eating Disorder Examination Questionnaire (EDE-Q) Score | If participants have a co-morbid diagnosis of an eating disorder, this self-report questionnaire will be used to monitor symptoms. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in Generalized Anxiety Disorder 7-item (GAD-7) Score | If participants have a co-morbid diagnosis of Anxiety, this self-report scale will be used to monitor anxiety symptoms. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in Yale Brown Cornell Eating Disorder Scale (YBC-EDS) Score | If participants have a co-morbid diagnosis of an eating disorder, this clinician-rated assessment will be used to monitor symptoms. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in Massachusetts General Hospital (MGH) Hairpulling Scale Score (Edited so Can be Used With Any Impulse Disorder) | If participants have a co-morbid diagnosis of an impulse disorder, this self-report questionnaire will be used to monitor symptoms. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in Obsessive Compulsive Inventory (OCI) Score | If participants have a co-morbid diagnosis of OCD, this self-report questionnaire will be used to monitor symptoms. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in Yalebrown Obsessive Compulsive Scale (YBOCS) Score | If participants have a co-morbid diagnosis of OCD, this clinician-rated scale will be used to monitor symptoms. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in Numeric Rating Scale For Pain Score | If participants have a co-morbid diagnosis of a pain disorder, this rating scale will be used to monitor symptoms. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in Panic Disorder Severity Scale (PDSS) Score | If participants have a co-morbid diagnosis of a panic disorder, this rating scale will be used to monitor symptoms. | Pre-treatment, after each day of stimulation and immediate post-treatmentAfter all stimulation sessions have been completed (approximately 48 hours after the final session) |
| PTSD Checklist Civilian Version (PCL-C) | If participants have a co-morbid diagnosis of PTSD, this self-report questionnaire will be used to monitor symptoms. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in Calgary Depression Scale For Schizophrenia (CDSS) Score | If participants have a co-morbid diagnosis of Schizophrenia, this assessment will be used to monitor symptoms. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Change in the Positive And Negative Syndrome Scale (PANSS) Score | If participants have a co-morbid diagnosis of Schizophrenia, this clinician-rated assessment will be used to monitor symptoms. | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
| Background |
| George MS, Wassermann EM, Williams WA, Callahan A, Ketter TA, Basser P, Hallett M, Post RM. Daily repetitive transcranial magnetic stimulation (rTMS) improves mood in depression. Neuroreport. 1995 Oct 2;6(14):1853-6. doi: 10.1097/00001756-199510020-00008. |
| 8684201 | Background | Pascual-Leone A, Rubio B, Pallardo F, Catala MD. Rapid-rate transcranial magnetic stimulation of left dorsolateral prefrontal cortex in drug-resistant depression. Lancet. 1996 Jul 27;348(9022):233-7. doi: 10.1016/s0140-6736(96)01219-6. |
The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline MADRS | A 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Severity gradations for the MADRS have been proposed: 9-17 = mild depression, 18-34 = moderate depression, and ≥ 35 = severe depression. Scores range from 0-60. | Mean | Standard Deviation | score on a scale |
|
| OG001 | Anterior Cingulate Cortex (ACC) | The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days. |
|
|
|
| Secondary | Change in Scale of Suicidal Ideation (SSI) Score | 19-item clinician administered assessment to measure the intensity, pervasiveness, and characteristics of suicidal ideation in adults. Scores range from 0-38. Higher scores indicate more suicidality. Data are presented as a raw score point change. | Only participants who completed the questionnaire were included in this analysis. | Posted | Mean | Standard Deviation | score on a scale | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
|
|
|
| Secondary | Change in Hamilton Rating Scale for Depression Six Item (HAMD-6) Score | Clinical assessment measuring depressive symptoms. Scores range from 0-24 with scores >5 indicating clinical levels of depressive symptoms (higher scores are more symptomatic). Data are presented as a raw score point change. | Only participants who completed the protocol were included in this analysis. | Posted | Mean | Standard Deviation | score on a scale | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
|
|
|
| Secondary | Change in Young Mania Rating Scale (YMRS) | The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Typical YMRS baseline scores can vary a lot. They depend on the patients' clinical features such as mania (YMRS = 12), depression (YMRS = 3), or euthymia (YMRS = 2). Data are presented as a raw score point change. | Only participants who completed the protocol were included in this analysis. | Posted | Mean | Standard Deviation | score on a scale | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
|
|
|
| Secondary | Change in Beck Depression Inventory II (BDI-II) | The Beck Depression Inventory (BDI-II) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. Scores: 0-13= minimal depression, 14-19=mild depression, 20-28=moderate depression, 29-63=severe depression. Data are presented as a raw score point change. | Only participants who completed the questionnaire were included in this analysis. | Posted | Mean | Standard Deviation | score on a scale | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
|
|
|
| Secondary | Change in Quick Inventory Depressive Scale-Self Reported (QIDS) Score | Self-report measure of depressive symptoms. The questionnaire consists of 16 questions. Each question can score between 0 to 4 points. Severity of depression is determined as follows: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Very Severe. Total scores range from 0-27. Total scores: 0-5= no depression, 6-10= mild depression, 11-15= moderate depression, 16-20= severe depression, 21-27= very severe depression. The total score is obtained by adding the scores for each of the nine symptom domains of the DSM-IV MDD criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes (Rush et al. 2003). Data are presented as a raw score point change. | Only participants who completed the protocol were included in this analysis. | Posted | Mean | Standard Deviation | score on a scale | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
|
|
|
| Secondary | Change in Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS-20) Score | Self-report, 20 item scale to determine patient's insomnia level. Each question can be scored between 0-3. 0=not bothered at all slightly bothered moderately bothered severely bothered Total score is calculated by adding up all questions (i.e. Q1+Q2+...Q20). One missing item is allowed, pro-rate if missing one item....i.e. (sum/count)*20. Minimum Score = 0 (good); Maximum Score = 60 (bad). Data are presented as a raw score point change. | Participants who completed this questionnaire were included in the analysis. Participants who do not have this data completed were excluded. | Posted | Mean | Standard Deviation | score on a scale | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
|
|
|
| Secondary | Change in Resting-state Recordings and TMS-evoked Potentials in EEG Data. | For the first and last stimulation session, EEG recording will be made before (resting-state EEG) and during (TMS-evoked potentials) the stimulation. | EEG data were not collected. | Posted | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
|
|
| Secondary | Biomarker Analysis in Patient Blood (Plasma) Samples | Blood (plasma) samples will be collected before and one month after stimulation. Blood collection is conducted by the registered hospital phlebotomist (following same protocol of a routine blood test). Blood samples will be analyzed by our collaborators at the Open Medicine Institute. Specifically, samples will be used for DNA/RNA extraction and analyses will be done to determine potential gene targets. Presence of inflammatory markers (cytokines) will also be determined. All analyses of blood samples will be conducted in the Open Medicine Institute. | Blood samples were not collected. | Posted | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
|
|
| Secondary | Biomarker Analysis in Patient Stool Samples | Stool samples will be collected before and one month after stimulation. Stool collection is performed by registered hospital nurses. Stool samples will be analyzed by our collaborators at the Open Medicine Institute. Specifically, stool samples will be analyzed for potential biomarkers in the gut microbiome. All analyses of stool samples will be conducted in the Open Medicine Institute. | Stool samples were not collected. | Posted | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
|
|
| Secondary | Biomarker Analysis in Patient Saliva Samples | Saliva samples will be collected before and one month after stimulation. Saliva collection is performed by registered study personnel. Saliva samples will be analyzed by our collaborators at the Open Medicine Institute. Specifically, saliva samples will be analyzed for cortisol levels. All analyses of stool samples will be conducted in the Open Medicine Institute. | Salvia samples were not collected. | Posted | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
|
|
| Secondary | Change in th Quality of Life Enjoyment and Satisfaction Questionnaire-short Form Score | 15-item self-report questionnaire where each item is scored from very poor=1 to very good=5. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are stand-alone items. The raw total score ranges from 14 (min) to 70 (max). | Only participants who completed this questionnaire were included in this analysis. | Posted | Mean | Standard Deviation | score on a scale | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
|
|
|
| Secondary | Change in Performance on the NIH Toolbox | Neurocognitive assessments delivered through an iPad app | NIH toolbox data was not collected. | Posted | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
|
|
| Secondary | Change in Immediate Mood Scaler (Ims-12) Depression Subscale Score | Immediate Mood Scaler (IMS) is a newly developed, iPad-deliverable 12-item self-report tool designed to capture current mood states with overall score, and depression and anxiety subscales. Individual item scores range from 1-7, with a total overall score range from 12-84. Data are presented as a raw score point change in depression subscale score. The depression subscale scores range from 7-49 (higher score indicating worse depression). | Participants who completed this questionnaire were included in the analysis. Participants who do not have this data completed were excluded. | Posted | Mean | Standard Deviation | score on a scale | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
|
|
|
| Secondary | Change in Heart Rate Variability | Measure presence of any change in heart rate variability. Data is reported as a ratio of low frequency (LF) and high frequency (HF) (LF/HF FFT). FFT: fast Fourier transform. | The device used to collect pilot HRV data was only acquired after the ACC participants had been run. Only participants with collected HRV data were included in the analysis. | Posted | Mean | Standard Deviation | LF/HF FFT ratio | After all stimulation sessions have been completed (approximately 48 hours after the final session) |
|
|
|
| Other Pre-specified | Change in Alcohol Craving Questionnaire Score (Adapted for All Drug Use) | If participants have a co-morbid diagnosis of drug abuse this self-report questionnaire will be used to monitor craving of their particular drug of abuse. | Not Posted | After all stimulation sessions have been completed (approximately 48 hours after the final session) | Participants |
| Other Pre-specified | Change in Borderline Evaluation Of Severity Over Time (BEST) Score | If participants have a co-morbid diagnosis of borderline personality disorder this self-report questionnaire will be used to monitor symptoms. | Not Posted | After all stimulation sessions have been completed (approximately 48 hours after the final session) | Participants |
| Other Pre-specified | Change in Obsessive Compulsive Drinking Scale Score (Adapted for Use of Any Drug) | If participants have a co-morbid diagnosis of drug abuse this self-report questionnaire will be used. | Not Posted | After all stimulation sessions have been completed (approximately 48 hours after the final session) | Participants |
| Other Pre-specified | Change in Average Weekly Substance Use | If participants have a co-morbid diagnosis of drug abuse their reported average weekly substance use will be recorded. | Not Posted | After all stimulation sessions have been completed (approximately 48 hours after the final session) | Participants |
| Other Pre-specified | Change in Eating Disorder Examination Questionnaire (EDE-Q) Score | If participants have a co-morbid diagnosis of an eating disorder, this self-report questionnaire will be used to monitor symptoms. | Not Posted | After all stimulation sessions have been completed (approximately 48 hours after the final session) | Participants |
| Other Pre-specified | Change in Generalized Anxiety Disorder 7-item (GAD-7) Score | If participants have a co-morbid diagnosis of Anxiety, this self-report scale will be used to monitor anxiety symptoms. | Not Posted | After all stimulation sessions have been completed (approximately 48 hours after the final session) | Participants |
| Other Pre-specified | Change in Yale Brown Cornell Eating Disorder Scale (YBC-EDS) Score | If participants have a co-morbid diagnosis of an eating disorder, this clinician-rated assessment will be used to monitor symptoms. | Not Posted | After all stimulation sessions have been completed (approximately 48 hours after the final session) | Participants |
| Other Pre-specified | Change in Massachusetts General Hospital (MGH) Hairpulling Scale Score (Edited so Can be Used With Any Impulse Disorder) | If participants have a co-morbid diagnosis of an impulse disorder, this self-report questionnaire will be used to monitor symptoms. | Not Posted | After all stimulation sessions have been completed (approximately 48 hours after the final session) | Participants |
| Other Pre-specified | Change in Obsessive Compulsive Inventory (OCI) Score | If participants have a co-morbid diagnosis of OCD, this self-report questionnaire will be used to monitor symptoms. | Not Posted | After all stimulation sessions have been completed (approximately 48 hours after the final session) | Participants |
| Other Pre-specified | Change in Yalebrown Obsessive Compulsive Scale (YBOCS) Score | If participants have a co-morbid diagnosis of OCD, this clinician-rated scale will be used to monitor symptoms. | Not Posted | After all stimulation sessions have been completed (approximately 48 hours after the final session) | Participants |
| Other Pre-specified | Change in Numeric Rating Scale For Pain Score | If participants have a co-morbid diagnosis of a pain disorder, this rating scale will be used to monitor symptoms. | Not Posted | After all stimulation sessions have been completed (approximately 48 hours after the final session) | Participants |
| Other Pre-specified | Change in Panic Disorder Severity Scale (PDSS) Score | If participants have a co-morbid diagnosis of a panic disorder, this rating scale will be used to monitor symptoms. | Not Posted | Pre-treatment, after each day of stimulation and immediate post-treatmentAfter all stimulation sessions have been completed (approximately 48 hours after the final session) | Participants |
| Other Pre-specified | PTSD Checklist Civilian Version (PCL-C) | If participants have a co-morbid diagnosis of PTSD, this self-report questionnaire will be used to monitor symptoms. | Not Posted | After all stimulation sessions have been completed (approximately 48 hours after the final session) | Participants |
| Other Pre-specified | Change in Calgary Depression Scale For Schizophrenia (CDSS) Score | If participants have a co-morbid diagnosis of Schizophrenia, this assessment will be used to monitor symptoms. | Not Posted | After all stimulation sessions have been completed (approximately 48 hours after the final session) | Participants |
| Other Pre-specified | Change in the Positive And Negative Syndrome Scale (PANSS) Score | If participants have a co-morbid diagnosis of Schizophrenia, this clinician-rated assessment will be used to monitor symptoms. | Not Posted | After all stimulation sessions have been completed (approximately 48 hours after the final session) | Participants |
| 0 |
| 20 |
| 1 |
| 20 |
| 7 |
| 20 |
| EG001 | Anterior Cingulate Cortex (ACC) | The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC) Accelerated theta burst stimulation: All participants will receive iTBS (intermittent theta burst stimulation) to the ACC. Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth). Stimulation will be delivered using the Brainsway TMS system. | 0 | 2 | 0 | 2 | 2 | 2 |
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| Fatigue | General disorders | Systematic Assessment |
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| Anxiety | Nervous system disorders | Systematic Assessment |
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| Pain during stimulation | General disorders | Systematic Assessment |
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| Toothache | General disorders | Systematic Assessment |
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| Jaw pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Redness on forehead | General disorders | Systematic Assessment |
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Not provided
Not provided