TMS for Post Stroke Depression

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

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.

Study Overview

• Status: Completed
• Conditions: Post-stroke Depression
• Intervention / Treatment: Device: TMS

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TMS; Open label single arm study to determine safety and effectiveness of TMS for post stroke depression	Device: TMS; NeuroStar TMS Therapy

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Amelia Adcock

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Stroke; Depression; Depressive Disorder
• Other Study ID Numbers: 1804090922

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes