TMS for Post Stroke Depression

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04093843

Enrollment

Registered

2019-09-18

Start date

2018-10-24

Completion date

2020-06-30

Last updated

2022-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-stroke Depression

Brief summary

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

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.

Interventions

DEVICETMS

NeuroStar TMS Therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Open label

Eligibility

Sex/Gender

ALL

Age

22 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Adverse Events	After Day 1 of rTMS treatment	Count of Adverse Events Reported during follow up
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale	Depressive symptoms will be quantified before the rTMS stimulation protocol	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)

Countries

United States

Participant flow

Participants by arm

Arm	Count
Open Label Open label single arm study to determine safety and effectiveness of TMS for post stroke depression TMS: NeuroStar TMS Therapy	6
Total	6

Baseline characteristics

Characteristic	Open Label	—
Age, Continuous	66.33 years STANDARD_DEVIATION 4.97	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	1 Participants	—
Sex: Female, Male Male	5 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 6
other Total, other adverse events	0 / 6
serious Total, serious adverse events	0 / 6

Outcome results

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)

Time frame: Depressive symptoms will be quantified immediately after the 4 days of rTMS stimulation.

Arm	Measure	Value (MEAN)	Dispersion
Open Label	Depressive Symptoms as Rated by the Hamilton Depression Rating Scale	4.17 score on a scale	Standard Deviation 0.98

Primary

Depressive Symptoms as Rated by the Hamilton Depression Rating Scale

Time frame: Depressive symptoms will be quantified before the rTMS stimulation protocol

Arm	Measure	Value (MEAN)	Dispersion
Open Label	Depressive Symptoms as Rated by the Hamilton Depression Rating Scale	15.50 score on a scale	Standard Deviation 2.81

Primary

Depressive Symptoms as Rated by the Hamilton Depression Rating Scale

Time frame: Depressive symptoms will be quantified 3 months after completion of the rTMS stimulation protocol.

Arm	Measure	Value (MEAN)	Dispersion
Open Label	Depressive Symptoms as Rated by the Hamilton Depression Rating Scale	3.50 score on a scale	Standard Deviation 2.66

Primary

Depressive Symptoms as Rated by the Hamilton Depression Rating Scale

Time frame: Depressive symptoms will be quantified 6 months after completion of the rTMS stimulation protocol.

Arm	Measure	Value (MEAN)	Dispersion
Open Label	Depressive Symptoms as Rated by the Hamilton Depression Rating Scale	5 score on a scale	Standard Deviation 3.05

Primary

Depressive Symptoms as Rated by the Hamilton Depression Rating Scale

Time frame: Depressive symptoms will be quantified 12 months after completion of the rTMS stimulation protocol.

Arm	Measure	Value (MEAN)	Dispersion
Open Label	Depressive Symptoms as Rated by the Hamilton Depression Rating Scale	4.667 score on a scale	Standard Deviation 5.022

Primary