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| Name | Class |
|---|---|
| Neuronetics | OTHER |
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This study is investigating a new indication of Transcranial Magnetic Stimulation (TMS) by conducting a pilot randomized-controlled trial (RCT) comparing structural neuronavigation-directed TMS to Sham-TMS Placebo therapy for treatment of Generalized Anxiety Disorder (GAD).
Participants will complete structural MRI for neuronavigation. Participants will be randomly assigned to treatment condition. TMS or Sham-TMS sessions will occur daily 5 days/week for 6 weeks. Assessments will occur at pretreatment, weekly during treatment, post-treatment, and 3 month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS Therapy | Experimental | TMS treatment |
|
| TMS-Sham | Sham Comparator | This is a sham TMS condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMS | Device | Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up. | Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. | Pretreatment, Post-treatment (6 weeks after pretreatment), 3-month follow-up |
| Responder Status | Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to post-treatment. | Post-treatment, 6 weeks |
| Remission Status | Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score < 8 and Clinical Global Impression Improvement score = 1 ("very much improved") or 2 ("much improved") at post-treatment. | post-treatment, 6 weeks |
| Responder Status | Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to 3-month follow-up. | 3-month follow-up |
| Remission Status | Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score < 8 and Clinical Global Impression Improvement score = 1 ("very much improved") or 2 ("much improved") at 3-month follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gretchen J Diefenbach, Ph.D. | Hartford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Hartford | Connecticut | 06105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27198484 | Derived | Diefenbach GJ, Bragdon LB, Zertuche L, Hyatt CJ, Hallion LS, Tolin DF, Goethe JW, Assaf M. Repetitive transcranial magnetic stimulation for generalised anxiety disorder: a pilot randomised, double-blind, sham-controlled trial. Br J Psychiatry. 2016 Sep;209(3):222-8. doi: 10.1192/bjp.bp.115.168203. Epub 2016 May 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TMS-Treatment | TMS treatment TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks. |
| FG001 | TMS-Sham | This is a sham TMS condition TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period |
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| |||||||||||||||||||||
| 3-month Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TMS Therapy | TMS treatment TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks. |
| BG001 | TMS-Sham |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up. | Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. | Intent-to-treat sample (n = 25) | Posted | Mean | Standard Deviation | units on a scale | Pretreatment, Post-treatment (6 weeks after pretreatment), 3-month follow-up |
|
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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 | TMS-Treatment | TMS treatment TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Cardiac disorders | Systematic Assessment | A patient in the active group was hospitalized for evaluation of chest pain; however, the event was determined to be unrelated to the study intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pin Prick Sensation | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gretchen J. Diefenbach, Ph.D | The Institute of Living | 860-545-7685 | Gretchen.Diefenbach@hhchealth.org |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety 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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| 3-month follow-up |
| Withdrawal by Subject |
|
| NOT COMPLETED |
|
|
This is a sham TMS condition
TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
This is a sham TMS condition
TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
|
|
|
| Primary | Responder Status | Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to post-treatment. | Post-treatment completers | Posted | Number | participants | Post-treatment, 6 weeks |
|
|
|
| Primary | Remission Status | Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score < 8 and Clinical Global Impression Improvement score = 1 ("very much improved") or 2 ("much improved") at post-treatment. | Post-treatment completers | Posted | Number | participants | post-treatment, 6 weeks |
|
|
|
| Primary | Responder Status | Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to 3-month follow-up. | 3-month follow-up completers | Posted | Number | participants | 3-month follow-up |
|
|
|
| Primary | Remission Status | Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score < 8 and Clinical Global Impression Improvement score = 1 ("very much improved") or 2 ("much improved") at 3-month follow-up. | 3-month follow-up completers | Posted | Number | participants | 3-month follow-up |
|
|
|
| 1 |
| 13 |
| 13 |
| 13 |
| EG001 | TMS-Sham | This is a sham TMS condition TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks. | 0 | 12 | 11 | 12 |
|
| Pain at the stimulation site | Nervous system disorders | Systematic Assessment |
|
| Facial pain (including eye pain) | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Toothache | Nervous system disorders | Systematic Assessment |
|
| Lightheaded or Dizziness | Nervous system disorders | Systematic Assessment |
|
| Facial twitch | Nervous system disorders | Systematic Assessment |
|
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