TMS for Post Stroke Depression

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-24

Study Completion Date

2020-06-30

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.

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Detailed Description

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The primary objectives of this project are as follows:

1. To assess the efficacy TMS in PSD. We hypothesize that there will be a decrease in the HAMD score in patients receiving TMS
2. 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.
3. 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.

Conditions

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Post-stroke Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open label

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TMS

Open label single arm study to determine safety and effectiveness of TMS for post stroke depression

Group Type EXPERIMENTAL

TMS

Intervention Type DEVICE

NeuroStar TMS Therapy

Interventions

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TMS

NeuroStar TMS Therapy

Intervention Type DEVICE

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

Minimum Eligible Age

22 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No