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Completed

NCT Number: NCT03701932

Mental Activity During (TMS) Therapy for Depression

The purpose of the study is to assess the effects of different types of mental activity performed while receiving transcranial magnetic stimulation (TMS) for the treatment of major depressive disorder. Our primary aim for this study is to assess the feasibility of combining TMS and computer based cognitive exercise in patients with major depressive disorder who may also have some degree of cognitive dysfunction, and to formally measure changes in mood and cognition over the course of the study.

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Key information

Conditions

Cognitive Impairment Behavior Behavioral Symptoms Cognition Disorders Cognitive Dysfunction Depression Mental Disorders Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Augusta University

Augusta, Georgia, 30912, United States

About this study

Patients will receive TMS treatment daily for 6 weeks as part of their standard care. They will complete clinical assessments and participate in cognitive retraining through completion of 15 hours of Lumosity gaming cognitive exercises while simultaneously receiving active TMS stimulation. Those participants in the control group will complete 15 hours of computer gaming activity during the administration of active stimulation. Computer games in the control group exercises are elected by the patient from a library of intellectually and motivationally engaging games drawn from several gaming software compilations that includes Play 101 Games and Hoyle Puzzle and Board Games.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • Subject has a diagnosis of depression
  • Subject has been approved and scheduled to receive TMS at Augusta University
  • Subject does not have a major neurocognitive impairment or an alcohol or substance abuse disorder, and can see images on a computer monitor.

Exclusion criteria

-

Treatment and study plan

TMS and Lumosity®cognitive retraining

Behavioral

The Lumosity® training includes exercises for speed, memory, attention, flexibility, and problem solving. Subjects will complete this battery while receiving TMS treatment.

TMS and non cognitive computer games

Behavioral

Subjects will play computer games while receiving TMS treatment.

Primary outcomes

  1. The University of Pennsylvania Computerized Neuropsychological Testing Battery (Penn CNP)

    Time frame: Change from baseline at six weeks

    Administers computerized neuropsychological tests for research studies

Secondary outcomes

  1. The Lumosity® Brain Performance Test (BPT)

    Time frame: Change from baseline at six weeks

    Online neuropsychological battery of assessments measuring training-related changes in Cognitive Performance

  2. Inventory of Depressive Symptoms- Self Report

    Time frame: Change from baseline at six weeks

    Patient rating of depressive symptom severity

  3. Hamilton Depression Rating Scale 17 item

    Time frame: Change from baseline at six weeks

    Clinician Rating of Depressive Symptoms

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Collaborators

  • Lumos Labs, Inc.

Registry information

Official study title

Mental Activity During Transcranial Magnetic Stimulation (TMS) Therapy for Depression

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 10, 2018
Registry last updated
Aug 28, 2020

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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