Mental Activity During (TMS) Therapy for Depression

August 27, 2020 updated by: Peter Rosenquist, Augusta University

Mental Activity During Transcranial Magnetic Stimulation (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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TMS and Lumosity® cognitive retraining
Group will receive TMS and will concurrently engage in cognitive retraining exercises comprised of the Lumosity® battery.
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.
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
Behavioral: TMS and non cognitive computer games
Subjects will play computer games while receiving TMS treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline at six weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Collaborators

Lumos Labs, Inc.

Investigators

  • Principal Investigator: Peter B Rosenquist, MD, Augusta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2015

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

March 26, 2018

First Submitted That Met QC Criteria

October 8, 2018

First Posted (Actual)

October 10, 2018

Study Record Updates

Last Update Posted (Actual)

August 28, 2020

Last Update Submitted That Met QC Criteria

August 27, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 663245

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

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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