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This an open label study using a FDA-cleared TMS stimulation protocols which will be used to treat patients who have responded or remitted from depression using acute clinical TMS therapy at the University of Missouri-Columbia Neuromodulation Clinic. TMS therapy will be given to subjects at monthly intervals. Depression severity questionnaires will be given monthly to determine if the subjects original response to TMS can be maintained. Subjects will be tapered down from antidepressant medication prior to TMS maintenance treatment. Results will be analyzed to determine the effectiveness and feasibility of maintenance TMS therapies in a clinical setting.
This an open label study using Transcranial Magnetic Stimulation (TMS) as a maintenance treatment for subjects that have seen a clinically significant response or remission from their depressive symptoms after having had an acute clinical course of TMS. All potential subjects must have been treated at the University of Missouri Columbia Neuromodulation Clinic to qualify.
There are 2 arms in this study. The first is a group of patients who will not receive any TMS treatments and will be followed for a year, and have their depression severity assessed monthly using the Personal Health Questionnaire (PHQ9), and the Quick Inventory of Depressive Symptoms.
The second arm will receive TMS treatments 5 times/month for 12 months, be assessed for changes in depressive symptom severity monthly using the PHQ9 and QIDS. TMS treatment protocols will consist of wither the standard 20min 10Hz protocol, or a 3min theta-burst protocol. The protocol used will be determined by what worked for the subject when they were treated clinically at the University of Missouri Columbia Neuromodulation clinic. Subjects in this arm will be tapered of antidepressant medication prior to monthly TMS treatment and will remain antidepressant free for the duration of the study.
The study will be a year long in duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS Treatment Arm | Active Comparator | Subjects will receive either a 20min 10hz TMS treatment, or a 3min theta-burst TMS treatment at certain monthly intervals. The TMS treatment protocol they receive depends on what they received in their acute clinical treatment. Subjects in the arm will be tapered off antidepressant medication before TMS treatment begins. Subjects will be assessed monthly for depression using QIDS and PHQ9. |
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| No TMS Arm | No Intervention | Subjects will be followed and assessed for depressive symptoms at monthly time intervals similar to the active treatment arm using QIDS and PHQ9. This group does not receive TMS treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMS treatment | Device | TMS using either a standard 10hz 20min or 3 min theta burst protocol |
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| Measure | Description | Time Frame |
|---|---|---|
| Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9) | The scale was given at the prior to study starting TMS treatments for the study as a baseline measurement. It was then given prior to every monthly TMS treatment block, scale is 0-27 with 0=no depression, 27=severe depression | given at monthly intervals for 12 months |
| Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores | The scale was given at the prior to study starting TMS treatments for the study as a baseline measurement. It was then given prior to every monthly TMS treatment block (Pre Trt Month) and after every monthly TMS treatment block (Post Trt Month) ,scale is 0-27 with 0=no depression, 27=severe depression | given at baseline and before and after TMS treatment block for 12 months |
| Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores | The scale was given at the prior to study starting TMS treatments for the study as a baseline measurement. It was then given prior to every monthly TMS treatment block (Pre Trt Month) and after every monthly TMS treatment block (Post Trt Month) ,scale is 0-27 with 0=no depression, 27=severe depression | given at baseline and before and after each TMS treatment block for 12 months |
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Inclusion Criteria:
Exclusion Criteria:
- Subject that has not completed a full acute treatment course, including taper
Subjects that have changed anything that may not make them safe for TMS, which are (all changes will be reviewed by study MD, and will not necessarily be excluded possibly depending on severity):
Subjects unwilling to sign consent or follow study procedures
Subjects with known extended travel plans which may affect study procedures and scheduled TMS treatment
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| Name | Affiliation | Role |
|---|---|---|
| Muaid Ithman, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri Neuromodulation Center | Columbia | Missouri | 65203 | United States |
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Participants had up to 8 weeks to washout of their antidepressant medication, if they could not handle this washout they could not start maintenance treatment. Although two arms were originally planned due to COVID the 2nd arm consisting of group of patients who will not receive any TMS treatments was unable to be recruited.
Dates of recruitment were from 8/14/2019 to 5/21/2021. Participants were recruited from outpatient interventional psychiatry clinic at University of Missouri
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| ID | Title | Description |
|---|---|---|
| FG000 | TMS Treatment Arm | Subjects will receive either a 20min 10hz TMS treatment, or a 3min theta-burst TMS treatment at certain monthly intervals. The TMS treatment protocol they receive depends on what they received in their acute clinical treatment. Subjects in the arm will be tapered off antidepressant medication before TMS treatment begins. Subjects will be assessed monthly for depression using QIDS and PHQ9. TMS treatment: TMS using either a standard 10hz 20min or 3 min theta burst protocol |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | TMS Treatment Arm | Subjects will receive either a 20min 10hz TMS treatment, or a 3min theta-burst TMS treatment at certain monthly intervals. The TMS treatment protocol they receive depends on what they received in their acute clinical treatment. Subjects in the arm will be tapered off antidepressant medication before TMS treatment begins. Subjects will be assessed monthly for depression using QIDS and PHQ9. TMS treatment: TMS using either a standard 10hz 20min or 3 min theta burst protocol |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9) | The scale was given at the prior to study starting TMS treatments for the study as a baseline measurement. It was then given prior to every monthly TMS treatment block, scale is 0-27 with 0=no depression, 27=severe depression | Posted | Mean | Standard Deviation | score on a scale | given at monthly intervals for 12 months |
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1 year
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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 Arm | Subjects will receive either a 20min 10hz TMS treatment, or a 3min theta-burst TMS treatment at certain monthly intervals. The TMS treatment protocol they receive depends on what they received in their acute clinical treatment. Subjects in the arm will be tapered off antidepressant medication before TMS treatment begins. Subjects will be assessed monthly for depression using QIDS and PHQ9. TMS treatment: TMS using either a standard 10hz 20min or 3 min theta burst protocol |
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Due to changes in staff and start of COVID our recruitment was limited. Orginally a non-TMS treatment arm was planned but due to COVID we were unable to recruit for this arm.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matt Schmidt | University of Missouri | 573-882-5688 | schmidtmw@health.missouri.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 17, 2019 | Nov 4, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Sex: Female, Male | Count of Participants | Participants |
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| Primary | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores | The scale was given at the prior to study starting TMS treatments for the study as a baseline measurement. It was then given prior to every monthly TMS treatment block (Pre Trt Month) and after every monthly TMS treatment block (Post Trt Month) ,scale is 0-27 with 0=no depression, 27=severe depression | Posted | Mean | Standard Deviation | score on a scale | given at baseline and before and after TMS treatment block for 12 months |
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| Primary | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores | The scale was given at the prior to study starting TMS treatments for the study as a baseline measurement. It was then given prior to every monthly TMS treatment block (Pre Trt Month) and after every monthly TMS treatment block (Post Trt Month) ,scale is 0-27 with 0=no depression, 27=severe depression | Posted | Mean | Standard Deviation | score on a scale | given at baseline and before and after each TMS treatment block for 12 months |
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