Mental Activity During (TMS) Therapy for Depression

Overview

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.

Full Title of Study: “Mental Activity During Transcranial Magnetic Stimulation (TMS) Therapy for Depression”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 31, 2019

Detailed Description

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.

Interventions

  • Behavioral: TMS and Lumosity®cognitive retraining
    • The Lumosity® training includes exercises for speed, memory, attention, flexibility, and problem solving. Subjects will complete this battery while receiving TMS treatment.
  • Behavioral: TMS and non cognitive computer games
    • Subjects will play computer games while receiving TMS treatment.

Arms, Groups and Cohorts

  • Experimental: TMS and Lumosity® cognitive retraining
    • Group will receive TMS and will concurrently engage in cognitive retraining exercises comprised of the Lumosity® battery.
  • Active Comparator: TMS and non cognitive computer games
    • Group will receive TMS while concurrently engaging in selected computer games from several gaming software that includes Play 101 Games and Hoyle Puzzle and Board Games®. They will also be allowed to spend time on gaming activities of their choice in order to keep them engaged

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • Inventory of Depressive Symptoms- Self Report
    • Time Frame: Change from baseline at six weeks
    • Patient rating of depressive symptom severity
  • Hamilton Depression Rating Scale 17 item
    • Time Frame: Change from baseline at six weeks
    • Clinician Rating of Depressive Symptoms

Participating in This Clinical Trial

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:

-

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Augusta University
  • Collaborator
    • Lumos Labs, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Peter Rosenquist, Professor – Augusta University
  • Overall Official(s)
    • Peter B Rosenquist, MD, Principal Investigator, Augusta University

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