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Completed

NCT Number: NCT04093843

TMS for Post Stroke Depression

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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Key information

Conditions

Post-stroke Depression

Age range

22 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Virginia University

Morgantown, West Virginia, 26506, United States

About this study

The primary objectives of this project are as follows:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TMS

Device

NeuroStar TMS Therapy

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: After Day 1 of rTMS treatment

    Count of Adverse Events Reported during follow up

  2. Number of Participants With Adverse Events

    Time frame: After Day 2 of rTMS treatment

    Count of Adverse Events Reported during follow up

  3. Number of Participants With Adverse Events

    Time frame: After Day 3 of rTMS treatment

    Count of Adverse Events Reported during follow up

  4. Number of Participants With Adverse Events

    Time frame: After Day 4 of rTMS treatment

    Count of Adverse Events Reported during follow up

  5. Number of Participants With Adverse Events

    Time frame: 3 months following neurostimulation

    Count of Adverse Events Reported during follow up

  6. Number of Participants With Adverse Events

    Time frame: 6 months following neurostimulation

    Count of Adverse Events Reported during follow up

  7. Number of Participants With Adverse Events

    Time frame: 12 months following neurostimulation

    Count of Adverse Events Reported during follow up

  8. Depressive Symptoms as Rated by the Hamilton Depression Rating Scale

    Time frame: 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)

  9. Depressive Symptoms as Rated by the Hamilton Depression Rating Scale

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

    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)

  10. 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.

    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)

  11. 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.

    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)

  12. 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.

    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)

Sponsors and collaborators

Lead sponsor

Amelia Adcock

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 18, 2019
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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