TMS for Post Stroke Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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The primary objectives of this project are as follows: To assess the efficacy TMS in PSD. We hypothesize that there will be a decrease in the HAMD score in patients receiving TMS To assess the feasibility of an accelerated protocol using rTMS in patients with acute to subacute stroke and co-existing PSD. We hypothesize that the accelerated protocol will promote compliance in our patient population and that the administration of this intervention is feasible. To assess the safety of rTMS in patients with acute to subacute stroke. We hypothesize that the side effects of TMS will be minimal and the therapy will be well-tolerated and safe in individuals with recent strokes and co-existing PSD.

Official Title
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Accelerated rTMS as a Treatment for Post-stroke Depression in the Subacute Phase: an Open Label Pilot Study

Conditions
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Post-stroke Depression

Intervention / Treatment
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* Device: TMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the ages of 22-85 years old Radiographic evidence of acute or subacute stroke Ischemic stroke diagnosed within the last 2 weeks to 6 months HAMD depression score 8 or greater Able to provide written informed consent Agree to participate in all study procedures Exclusion Criteria: Metallic objects or neurostimulators implanted intracranially Stroke in the area of stimulation Current thoughts of SI or self-harm as assessed by the M.I.N.I. Suicide Scale score > 8 ASRM (Altman Self Rating Mania Scale) score > 6 (6 or above indicates likelihood of manic symptoms) Current use of illicit substances Known history of epilepsy or seizure disorder Clinically significant EKG abnormalities including QTC prolongation >450 ms in men or >480 ms in women

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMS<br>Open label single arm study to determine safety and effectiveness of TMS for post stroke depression | Device: TMS<br>* NeuroStar TMS Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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. |