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The purpose of this study is to find alternative treatments for patient's suffering from depression after having a stroke.This study aims to show that accelerated rTMS is a safe, effective,and convenient treatment for patient's suffering from post-stroke depression in the acute to subacute phase. This will be an open label trial and thus all participants will receive the active rTMS intervention.
The primary objectives of this project are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS | Experimental | Open label single arm study to determine safety and effectiveness of TMS for post stroke depression |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMS | Device | NeuroStar TMS Therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Count of Adverse Events Reported during follow up | After Day 1 of rTMS treatment |
| Number of Participants With Adverse Events | Count of Adverse Events Reported during follow up | After Day 2 of rTMS treatment |
| Number of Participants With Adverse Events | Count of Adverse Events Reported during follow up | After Day 3 of rTMS treatment |
| Number of Participants With Adverse Events | Count of Adverse Events Reported during follow up | After Day 4 of rTMS treatment |
| Number of Participants With Adverse Events | Count of Adverse Events Reported during follow up | 3 months following neurostimulation |
| Number of Participants With Adverse Events | Count of Adverse Events Reported during follow up | 6 months following neurostimulation |
| Number of Participants With Adverse Events | Count of Adverse Events Reported during follow up | 12 months following neurostimulation |
| Depressive Symptoms as Rated by the Hamilton Depression Rating Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32849235 | Derived | Frey J, Najib U, Lilly C, Adcock A. Novel TMS for Stroke and Depression (NoTSAD): Accelerated Repetitive Transcranial Magnetic Stimulation as a Safe and Effective Treatment for Post-stroke Depression. Front Neurol. 2020 Aug 11;11:788. doi: 10.3389/fneur.2020.00788. eCollection 2020. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TMS: NeuroStar TMS Therapy | Open label single arm study to determine safety and effectiveness of TMS for post stroke depression TMS: NeuroStar TMS Therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label | Open label single arm study to determine safety and effectiveness of TMS for post stroke depression TMS: NeuroStar TMS Therapy |
| 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 | Number of Participants With Adverse Events | Count of Adverse Events Reported during follow up | Posted | Count of Participants | Participants | After Day 1 of rTMS treatment |
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1 year
Adverse events will be monitored via the adverse events screening forms and patients will be routinely asked if they are experiencing any side effects during the treatment process.
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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 | Open Label | Open label single arm study to determine safety and effectiveness of TMS for post stroke depression TMS: NeuroStar TMS Therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amelia Adcock, MD | West Virginia University | 304-598-6127 | akadcock@hsc.wvu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 25, 2019 | Jul 28, 2021 | Prot_SAP_ICF_000.pdf |
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Open label
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Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
| Depressive symptoms will be quantified before the rTMS stimulation protocol |
| Depressive Symptoms as Rated by the Hamilton Depression Rating Scale | Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible) | Depressive symptoms will be quantified immediately after the 4 days of rTMS stimulation. |
| Depressive Symptoms as Rated by the Hamilton Depression Rating Scale | Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible) | Depressive symptoms will be quantified 3 months after completion of the rTMS stimulation protocol. |
| Depressive Symptoms as Rated by the Hamilton Depression Rating Scale | Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible) | Depressive symptoms will be quantified 6 months after completion of the rTMS stimulation protocol. |
| Depressive Symptoms as Rated by the Hamilton Depression Rating Scale | Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible) | Depressive symptoms will be quantified 12 months after completion of the rTMS stimulation protocol. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Primary | Number of Participants With Adverse Events | Count of Adverse Events Reported during follow up | Posted | Count of Participants | Participants | After Day 2 of rTMS treatment |
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| Primary | Number of Participants With Adverse Events | Count of Adverse Events Reported during follow up | Posted | Count of Participants | Participants | After Day 3 of rTMS treatment |
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| Primary | Number of Participants With Adverse Events | Count of Adverse Events Reported during follow up | Posted | Count of Participants | Participants | After Day 4 of rTMS treatment |
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| Primary | Number of Participants With Adverse Events | Count of Adverse Events Reported during follow up | Posted | Count of Participants | Participants | 3 months following neurostimulation |
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| Primary | Number of Participants With Adverse Events | Count of Adverse Events Reported during follow up | Posted | Count of Participants | Participants | 6 months following neurostimulation |
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| Primary | Number of Participants With Adverse Events | Count of Adverse Events Reported during follow up | Posted | Count of Participants | Participants | 12 months following neurostimulation |
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| Primary | Depressive Symptoms as Rated by the Hamilton Depression Rating Scale | Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible) | Posted | Mean | Standard Deviation | score on a scale | Depressive symptoms will be quantified before the rTMS stimulation protocol |
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| Primary | Depressive Symptoms as Rated by the Hamilton Depression Rating Scale | Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible) | Posted | Mean | Standard Deviation | score on a scale | Depressive symptoms will be quantified immediately after the 4 days of rTMS stimulation. |
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| Primary | Depressive Symptoms as Rated by the Hamilton Depression Rating Scale | Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible) | Posted | Mean | Standard Deviation | score on a scale | Depressive symptoms will be quantified 3 months after completion of the rTMS stimulation protocol. |
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| Primary | Depressive Symptoms as Rated by the Hamilton Depression Rating Scale | Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible) | Posted | Mean | Standard Deviation | score on a scale | Depressive symptoms will be quantified 6 months after completion of the rTMS stimulation protocol. |
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| Primary | Depressive Symptoms as Rated by the Hamilton Depression Rating Scale | Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible) | Posted | Mean | Standard Deviation | score on a scale | Depressive symptoms will be quantified 12 months after completion of the rTMS stimulation protocol. |
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