TMS for Post Stroke Depression

Post-stroke Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04093843
• Other study ID #: 1804090922
• Status: Completed
• Phase: N/A
• Start date: October 24, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2022
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Post-stroke Depression
• Stroke

Intervention

Device:
• TMS
NeuroStar TMS Therapy

Locations

Country	Name	City	State
United States	West Virginia University	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Amelia Adcock

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	Count of Adverse Events Reported during follow up	After Day 1 of rTMS treatment
Primary	Number of Participants With Adverse Events	Count of Adverse Events Reported during follow up	After Day 2 of rTMS treatment
Primary	Number of Participants With Adverse Events	Count of Adverse Events Reported during follow up	After Day 3 of rTMS treatment
Primary	Number of Participants With Adverse Events	Count of Adverse Events Reported during follow up	After Day 4 of rTMS treatment
Primary	Number of Participants With Adverse Events	Count of Adverse Events Reported during follow up	3 months following neurostimulation
Primary	Number of Participants With Adverse Events	Count of Adverse Events Reported during follow up	6 months following neurostimulation
Primary	Number of Participants With Adverse Events	Count of Adverse Events Reported during follow up	12 months following neurostimulation
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)	Depressive symptoms will be quantified before the rTMS stimulation protocol
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)	Depressive symptoms will be quantified immediately after the 4 days of rTMS stimulation.
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)	Depressive symptoms will be quantified 3 months after completion of the rTMS stimulation protocol.
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)	Depressive symptoms will be quantified 6 months after completion of the rTMS stimulation protocol.
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)	Depressive symptoms will be quantified 12 months after completion of the rTMS stimulation protocol.