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This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant depression. In a double-blind fashion, half the participants will receive accelerated theta-burst stimulation while half will receive sham treatment.
Repetitive transcranial magnetic stimulation (rTMS) is an established therapy for treatment-resistant depression. The approved method for treatment is 10Hz stimulation for 40 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been effective in real world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session, 5 days per week, for 4-8 weeks). Recently, researchers have pursued modifying the treatment parameters to reduce treatment times with some preliminary successes. This study aims to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TBS-DLPFC | Experimental | The active group will receive theta-burst TMS stimulation. |
|
| Sham TBS-DLPFC | Sham Comparator | The sham group will receive sham theta-burst TMS stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active TBS-DLPFC | Device | Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004). Stimulation will be delivered to the L-DLPFC using a MagPro stimulator. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score From Pre-treatment to 1-month Post-treatment. | A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.The MADRS has an overall score range from 0-60, with higher scores corresponding to higher levels of depression. | Pretreatment (baseline), 1-month post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in the Hamilton Rating Scale for Depression (HAMD-17) | A provider administered questionnaire used to assess remission and recovery from depression. The HAMD-17 is a 17-item questionnaire to assess depression severity. Each item is scored from 0-4, with higher scores representing increasing depression severity. | pre-treatment (baseline) to 1-month post-treatment |
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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 |
|---|---|---|---|---|---|---|
| Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine | Stanford | 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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| ID | Title | Description |
|---|---|---|
| FG000 | Active TBS-DLPFC | The active group will receive theta-burst TMS stimulation. Active TBS-DLPFC: Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004). Stimulation will be delivered to the L-DLPFC using a MagPro stimulator. Open label TBS-DLPFC: All patients will have the option to receive active, open label aTBS treatment after the 1-month mark, following the blinded phase. Stimulation will be delivered to the L-DLPFC using a MagPro stimulator or Nexstim TMS device. |
| FG001 | Sham TBS-DLPFC | The sham group will receive sham theta-burst TMS stimulation. Sham TBS-DLPFC: The parameters in the active arms will be as above with the internal randomization of the device internally switching to sham in a blinded fashion. Open label TBS-DLPFC: All patients will have the option to receive active, open label aTBS treatment after the 1-month mark, following the blinded phase. Stimulation will be delivered to the L-DLPFC using a MagPro stimulator or Nexstim TMS device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active TBS-DLPFC | The active group will receive theta-burst TMS stimulation. Active TBS-DLPFC: Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004). Stimulation will be delivered to the L-DLPFC using a MagPro stimulator. |
| 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 | Percentage Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score From Pre-treatment to 1-month Post-treatment. | A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.The MADRS has an overall score range from 0-60, with higher scores corresponding to higher levels of depression. | Participants who completed the protocol are included in the analysis. | Posted | Mean | Standard Deviation | percent change in MADRS score | Pretreatment (baseline), 1-month post-treatment |
|
4 weeks
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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 | Active TBS-DLPFC | The active group will receive theta-burst TMS stimulation. Active TBS-DLPFC: Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004). Stimulation will be delivered to the L-DLPFC using a MagPro stimulator. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
Data analysis for secondary outcome measures 3 (Change in C-SSRS score) and 4 (Change in HAM-6 score) are considered to be under powered, due to small number of subjects having available data for analysis.
| 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 | Yes | No | No | Study Protocol | Sep 18, 2018 | Mar 5, 2021 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 25, 2021 | Jan 25, 2021 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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|
| Sham TBS-DLPFC | Device | The parameters in the active arms will be as above with the internal randomization of the device internally switching to sham in a blinded fashion. |
|
| Open label TBS-DLPFC | Device | All patients will have the option to receive active, open label aTBS treatment after the 1-month mark, following the blinded phase. Stimulation will be delivered to the L-DLPFC using a MagPro stimulator or Nexstim TMS device. |
|
| Change in the Columbia Suicide Severity Rating Scale (C-SSRS) Score | The Columbia-Suicide Severity Rating Scale (C-SSRS) is a questionnaire used for suicide assessment developed by multiple institutions including Columbia University. Participants were asked a series of 6 yes or no questions. Yes answers indicate more suicidal ideation. Here we report a count of participants with an increase, decrease or no change in suicidal ideation. | Pretreatment (baseline) to immediately post-treatment (day 8). |
| Change in the Hamilton Rating Scale for Depression (HAM-6) Score | The Hamilton Depression Rating Scale (HDRS, also known as Ham-D) is the most widely used clinician-administered depression assessment scale. The Ham-6 version consists of 6 items assessing for: mood, guilt, general somatic symptoms, work and activities, anxiety and slowness of thought and speech). Each item is scored on a scale of 0 to 4, except for the somatic symptoms item, which is scored 0 to 2. On the HAM-6 there can be a total score of 22. Higher scores represent higher depression severity. Here, we report a count of participants with an overall increase, decrease or no change in total HAM-6 score. Participants with an increase in total score (row 3) would signify a worse outcome than participants with a decrease in total score. | Baseline (pre-treatment) and at 1-month post-treatment |
| Percentage Change in the Hamilton Rating Scale for Depression (HAMD-17) | The Hamilton Depression Rating Scale (HDRS, also known as Ham-D) is the most widely used clinician-administered depression assessment scale. The Ham-17 version consists of 17 items assessing for: mood, guilt, general somatic symptoms, work and activities, anxiety and slowness of thought and speech. Each item is scored on a scale of 0 to 4, except for the somatic, sleep and insight items which are scored 0 to 2. On the HAM-17 there can be a total score of 22. Higher scores represent higher depression severity. | Pre-treatment (baseline) to immediately post-treatment (day 8). |
| Change From Baseline Functional Connectivity to Immediate Post-treatment | We quantified the functional connectivity change between the subcallosal cingulate to the default mode network and within the default mode network using baseline and immediate post-treatment MRI scans. We report below, changes of functional connectivity (Fisher's Z score of Pearson correlation coefficient for each pair of ROIs) from immediately post-treatment (day 8) to baseline. | Pretreatment (baseline) to immediately post-treatment (day 8). |
| Change From Baseline Functional Connectivity to 1-month Post-treatment | We will assess functional connectivity as seen on resting state fMRI, between the subcallosal cingulate to the default mode network and within the default mode network. We report below, changes of functional connectivity (Fisher's Z score of Pearson correlation coefficient for each pair of ROIs) from post-treatment(1m) to baseline. | Pretreatment (baseline) to 1-month post-treatment |
| Change in Baseline Heart Rate Variability to 1-month Post-treatment | Heart rate variability measures will be compared pre-treatment and 1-month post-treatment. | Pretreatment to 1-month post-treatment |
| Change in Baseline Heart Rate Variability to Immediate Post-treatment | Heart rate variability measures will be compared pre-treatment and immediately post-treatment. | Pretreatment to immediate post-treatment (day 8). |
| 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. |
| 26850210 | Background | Chung SW, Hill AT, Rogasch NC, Hoy KE, Fitzgerald PB. Use of theta-burst stimulation in changing excitability of motor cortex: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2016 Apr;63:43-64. doi: 10.1016/j.neubiorev.2016.01.008. Epub 2016 Feb 3. |
| 25281475 | Background | Jelic MB, Milanovic SD, Filipovic SR. Differential effects of facilitatory and inhibitory theta burst stimulation of the primary motor cortex on motor learning. Clin Neurophysiol. 2015 May;126(5):1016-23. doi: 10.1016/j.clinph.2014.09.003. Epub 2014 Sep 16. |
| 25450537 | Background | Chung SW, Hoy KE, Fitzgerald PB. Theta-burst stimulation: a new form of TMS treatment for depression? Depress Anxiety. 2015 Mar;32(3):182-92. doi: 10.1002/da.22335. Epub 2014 Nov 28. |
| 24411682 | Background | Plewnia C, Pasqualetti P, Grosse S, Schlipf S, Wasserka B, Zwissler B, Fallgatter A. Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial. J Affect Disord. 2014 Mar;156:219-23. doi: 10.1016/j.jad.2013.12.025. Epub 2013 Dec 28. |
| 25430687 | Background | Prasser J, Schecklmann M, Poeppl TB, Frank E, Kreuzer PM, Hajak G, Rupprecht R, Landgrebe M, Langguth B. Bilateral prefrontal rTMS and theta burst TMS as an add-on treatment for depression: a randomized placebo controlled trial. World J Biol Psychiatry. 2015 Jan;16(1):57-65. doi: 10.3109/15622975.2014.964768. Epub 2014 Nov 28. |
| 24833712 | Background | Daskalakis ZJ. Theta-burst transcranial magnetic stimulation in depression: when less may be more. Brain. 2014 Jul;137(Pt 7):1860-2. doi: 10.1093/brain/awu123. Epub 2014 May 15. No abstract available. |
| 19862614 | Background | Thut G, Pascual-Leone A. A review of combined TMS-EEG studies to characterize lasting effects of repetitive TMS and assess their usefulness in cognitive and clinical neuroscience. Brain Topogr. 2010 Jan;22(4):219-32. doi: 10.1007/s10548-009-0115-4. Epub 2009 Oct 28. |
| 20734360 | Background | Holtzheimer PE 3rd, McDonald WM, Mufti M, Kelley ME, Quinn S, Corso G, Epstein CM. Accelerated repetitive transcranial magnetic stimulation for treatment-resistant depression. Depress Anxiety. 2010 Oct;27(10):960-3. doi: 10.1002/da.20731. |
| 24060620 | Background | Fung PK, Robinson PA. Neural field theory of synaptic metaplasticity with applications to theta burst stimulation. J Theor Biol. 2014 Jan 7;340:164-76. doi: 10.1016/j.jtbi.2013.09.021. Epub 2013 Sep 21. |
| 8524021 | Background | Biswal B, Yetkin FZ, Haughton VM, Hyde JS. Functional connectivity in the motor cortex of resting human brain using echo-planar MRI. Magn Reson Med. 1995 Oct;34(4):537-41. doi: 10.1002/mrm.1910340409. |
| 12506194 | Background | Greicius MD, Krasnow B, Reiss AL, Menon V. Functional connectivity in the resting brain: a network analysis of the default mode hypothesis. Proc Natl Acad Sci U S A. 2003 Jan 7;100(1):253-8. doi: 10.1073/pnas.0135058100. Epub 2002 Dec 27. |
| 15976020 | Background | Fox MD, Snyder AZ, Vincent JL, Corbetta M, Van Essen DC, Raichle ME. The human brain is intrinsically organized into dynamic, anticorrelated functional networks. Proc Natl Acad Sci U S A. 2005 Jul 5;102(27):9673-8. doi: 10.1073/pnas.0504136102. Epub 2005 Jun 23. |
| 18403396 | Background | Greicius MD, Supekar K, Menon V, Dougherty RF. Resting-state functional connectivity reflects structural connectivity in the default mode network. Cereb Cortex. 2009 Jan;19(1):72-8. doi: 10.1093/cercor/bhn059. Epub 2008 Apr 9. |
| 37400432 | Derived | Batail JM, Xiao X, Azeez A, Tischler C, Kratter IH, Bishop JH, Saggar M, Williams NR. Network effects of Stanford Neuromodulation Therapy (SNT) in treatment-resistant major depressive disorder: a randomized, controlled trial. Transl Psychiatry. 2023 Jul 3;13(1):240. doi: 10.1038/s41398-023-02537-9. |
| 34711062 | Derived | Cole EJ, Phillips AL, Bentzley BS, Stimpson KH, Nejad R, Barmak F, Veerapal C, Khan N, Cherian K, Felber E, Brown R, Choi E, King S, Pankow H, Bishop JH, Azeez A, Coetzee J, Rapier R, Odenwald N, Carreon D, Hawkins J, Chang M, Keller J, Raj K, DeBattista C, Jo B, Espil FM, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022 Feb;179(2):132-141. doi: 10.1176/appi.ajp.2021.20101429. Epub 2021 Oct 29. |
| BG001 | Sham TBS-DLPFC | The sham group will receive sham theta-burst TMS stimulation. Sham TBS-DLPFC: The parameters in the active arms will be as above with the internal randomization of the device internally switching to sham in a blinded fashion. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Years of education | Mean | Full Range | years |
|
| Currently employed | Count of Participants | Participants |
|
| Duration of illness | Mean | Full Range | years |
|
| Duration of current depressive episode | Mean | Full Range | years |
|
| ATHF adequate antidepressant trials, lifetime | Mean | Full Range | number of lifetime antidepressant trials |
|
| ATHF adequate augmentation trials, lifetime | Mean | Full Range | number of lifetime augmentation trials |
|
| ATHF adequate antidepressant trials, current episode | Mean | Full Range | number of current antidepressant trials |
|
| ATHF adequate augmentation trials, current episode | Mean | Full Range | number of current augmentation trials |
|
| Maudsley Staging Method Score | The Maudsley Staging Method (MSM) is a points-based staging model incorporating 3 factors: treatment, severity of illness, and duration of presenting episode. The overall level of resistance estimated using this model varies from minimal resistance (score of 3) to severe resistance (score of 15). | Mean | Full Range | score on a scale |
|
| Baseline MADRS overall score | The Montgomery-Åsberg Depression Rating Scale (MADRS), is a ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Overall scores above 34 indicate severe depression. | Mean | Full Range | score on a scale |
|
| Baseline HAM-6 score | The Hamilton Depression Rating Scale (HDRS, also known as Ham-D) is the most widely used clinician-administered depression assessment scale. Scores can range from 0 to 22. Higher scores represent higher depression severity. | Mean | Full Range | score on a scale |
|
| OG001 | Sham TBS-DLPFC | The sham group will receive sham theta-burst TMS stimulation. Sham TBS-DLPFC: The parameters in the active arms will be as above with the internal randomization of the device internally switching to sham in a blinded fashion. |
|
|
|
| Secondary | Percentage Change in the Hamilton Rating Scale for Depression (HAMD-17) | A provider administered questionnaire used to assess remission and recovery from depression. The HAMD-17 is a 17-item questionnaire to assess depression severity. Each item is scored from 0-4, with higher scores representing increasing depression severity. | Participants who completed the protocol are included in the analysis. | Posted | Mean | Standard Deviation | percent change in HAM-17 score | pre-treatment (baseline) to 1-month post-treatment |
|
|
|
|
| Secondary | Change in the Columbia Suicide Severity Rating Scale (C-SSRS) Score | The Columbia-Suicide Severity Rating Scale (C-SSRS) is a questionnaire used for suicide assessment developed by multiple institutions including Columbia University. Participants were asked a series of 6 yes or no questions. Yes answers indicate more suicidal ideation. Here we report a count of participants with an increase, decrease or no change in suicidal ideation. | Participants with available data are included in this analysis. Only participants with paired data are included. | Posted | Count of Participants | Participants | Pretreatment (baseline) to immediately post-treatment (day 8). |
|
|
|
| Secondary | Change in the Hamilton Rating Scale for Depression (HAM-6) Score | The Hamilton Depression Rating Scale (HDRS, also known as Ham-D) is the most widely used clinician-administered depression assessment scale. The Ham-6 version consists of 6 items assessing for: mood, guilt, general somatic symptoms, work and activities, anxiety and slowness of thought and speech). Each item is scored on a scale of 0 to 4, except for the somatic symptoms item, which is scored 0 to 2. On the HAM-6 there can be a total score of 22. Higher scores represent higher depression severity. Here, we report a count of participants with an overall increase, decrease or no change in total HAM-6 score. Participants with an increase in total score (row 3) would signify a worse outcome than participants with a decrease in total score. | Participants with available data are included in this analysis. Only participants with paired data are included. Scores are marked as a change from baseline if the difference is greater than 1 point. | Posted | Count of Participants | Participants | Baseline (pre-treatment) and at 1-month post-treatment |
|
|
|
| Secondary | Percentage Change in the Hamilton Rating Scale for Depression (HAMD-17) | The Hamilton Depression Rating Scale (HDRS, also known as Ham-D) is the most widely used clinician-administered depression assessment scale. The Ham-17 version consists of 17 items assessing for: mood, guilt, general somatic symptoms, work and activities, anxiety and slowness of thought and speech. Each item is scored on a scale of 0 to 4, except for the somatic, sleep and insight items which are scored 0 to 2. On the HAM-17 there can be a total score of 22. Higher scores represent higher depression severity. | Participants who completed the protocol are included in the analysis. | Posted | Mean | Standard Deviation | percent change in score | Pre-treatment (baseline) to immediately post-treatment (day 8). |
|
|
|
|
| Secondary | Change From Baseline Functional Connectivity to Immediate Post-treatment | We quantified the functional connectivity change between the subcallosal cingulate to the default mode network and within the default mode network using baseline and immediate post-treatment MRI scans. We report below, changes of functional connectivity (Fisher's Z score of Pearson correlation coefficient for each pair of ROIs) from immediately post-treatment (day 8) to baseline. | Participants with available data were included in the analysis. | Posted | Mean | Standard Deviation | Z-score | Pretreatment (baseline) to immediately post-treatment (day 8). |
|
|
|
|
| Secondary | Change From Baseline Functional Connectivity to 1-month Post-treatment | We will assess functional connectivity as seen on resting state fMRI, between the subcallosal cingulate to the default mode network and within the default mode network. We report below, changes of functional connectivity (Fisher's Z score of Pearson correlation coefficient for each pair of ROIs) from post-treatment(1m) to baseline. | Participants with available data were included in the analysis. | Posted | Mean | Standard Deviation | Z-score | Pretreatment (baseline) to 1-month post-treatment |
|
|
|
|
| Secondary | Change in Baseline Heart Rate Variability to 1-month Post-treatment | Heart rate variability measures will be compared pre-treatment and 1-month post-treatment. | Smaller than the total number of participants because some did not have data collected for this measure at either timepoint. | Posted | Mean | Standard Error | SDNN in milliseconds | Pretreatment to 1-month post-treatment |
|
|
|
|
| Secondary | Change in Baseline Heart Rate Variability to Immediate Post-treatment | Heart rate variability measures will be compared pre-treatment and immediately post-treatment. | Data from 18 participants analyzed. Smaller than the total number of participants for this study because some participants were missing one or both of the timepoints needed for this variable. | Posted | Mean | Standard Error | SDNN in milliseconds | Pretreatment to immediate post-treatment (day 8). |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 12 |
| 14 |
| EG001 | Sham TBS-DLPFC | The sham group will receive sham theta-burst TMS stimulation. Sham TBS-DLPFC: The parameters in the active arms will be as above with the internal randomization of the device internally switching to sham in a blinded fashion. | 0 | 15 | 0 | 15 | 11 | 15 |
| Neck/back discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Discomfort at treatment site | General disorders | Systematic Assessment |
|
| Post-SAINT headache | Nervous system disorders | Systematic Assessment |
|
| Anxiety | Nervous system disorders | Systematic Assessment |
|
| Dental issues | General disorders | Systematic Assessment |
|
| Jaw discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Polydipsia | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| No Change |
|
| Increased |
|
| Functional connectivity between lsgACC_lDMN in participants receiving sham iTBS. | t-test, 2 sided | Paired t-test was used for the statistics. | =0.778 | Superiority | FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis. sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas. |
| Functional connectivity between lDMN_rDMN in participants receiving active iTBS. | t-test, 2 sided | Paired t-test was used for the statistics. | =0.468 | Superiority | FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis. sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas. |
| Functional connectivity between lDMN_rDMN in participants receiving sham iTBS. | t-test, 2 sided | Paired t-test was used for the statistics. | =0.486 | Superiority | FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis. sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas. |
| Functional connectivity between lsgACC_lDMN in participants receiving sham iTBS. | t-test, 2 sided | Paired t-test was used for the statistics. | =0.115 | Superiority | FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis. sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas. |
| Functional connectivity between lDMN_rDMN in participants receiving active iTBS. | t-test, 2 sided | Paired t-test was used for the statistics. | =0.546 | Superiority | FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis. sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas. |
| Functional connectivity between lDMN_rDMN in participants receiving sham iTBS. | t-test, 2 sided | =0.607 | Superiority | FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis. sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas. |