TMS for Post Stroke Depression

NCT04093843 | Completed Results DMC FDA Device

• 1 other identifier: 1804090922
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-stroke Depression

Outcome Measures

Primary Outcomes (12)

• 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.

Study Arms (1)

TMS

EXPERIMENTAL

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

Device: TMS

Interventions

TMS DEVICE

NeuroStar TMS Therapy

TMS

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amelia Adcock: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

• 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.

  PMID: 32849235 DERIVED

Results Point of Contact

• Title: Amelia Adcock, MD
• Organization: West Virginia University

akadcock@hsc.wvu.edu

304-598-6127

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Model Details: Open label

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: September 18, 2019
• Study Start: October 24, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: April 29, 2022
• Results First Posted: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)