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Mental Activity During (TMS) Therapy for Depression

Primary Purpose

Cognitive Impairment

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

TMS and Lumosity®cognitive retraining

TMS and non cognitive computer games

About this trial

This is an interventional treatment trial for Cognitive Impairment focused on measuring Depression, Transcranial Magnetic Stimulation (TMS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

Augusta University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TMS and Lumosity® cognitive retraining

TMS and non cognitive computer games

Arm Description

Group will receive TMS and will concurrently engage in cognitive retraining exercises comprised of the Lumosity® battery.

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

Outcomes

Primary Outcome Measures

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

Administers computerized neuropsychological tests for research studies

Secondary Outcome Measures

The Lumosity® Brain Performance Test (BPT)

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

Inventory of Depressive Symptoms- Self Report

Patient rating of depressive symptom severity

Hamilton Depression Rating Scale 17 item

Clinician Rating of Depressive Symptoms

Full Information

NCT ID

NCT03701932

First Posted

March 26, 2018

Last Updated

August 27, 2020

Sponsor

Augusta University

Collaborators

Lumos Labs, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03701932

Brief Title

Mental Activity During (TMS) Therapy for Depression

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

March 6, 2015 (Actual)

Primary Completion Date

July 31, 2019 (Actual)

Study Completion Date

July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Augusta University

Collaborators

Lumos Labs, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Impairment

Keywords

Depression, Transcranial Magnetic Stimulation (TMS)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TMS and Lumosity® cognitive retraining

Arm Type

Experimental

Arm Description

Group will receive TMS and will concurrently engage in cognitive retraining exercises comprised of the Lumosity® battery.

Arm Title

TMS and non cognitive computer games

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

TMS and Lumosity®cognitive retraining

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

TMS and non cognitive computer games

Intervention Description

Subjects will play computer games while receiving TMS treatment.

Primary Outcome Measure Information:

Title

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

Description

Administers computerized neuropsychological tests for research studies

Time Frame

Change from baseline at six weeks

Secondary Outcome Measure Information:

Title

The Lumosity® Brain Performance Test (BPT)

Description

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

Time Frame

Change from baseline at six weeks

Title

Inventory of Depressive Symptoms- Self Report

Description

Patient rating of depressive symptom severity

Time Frame

Change from baseline at six weeks

Title

Hamilton Depression Rating Scale 17 item

Description

Clinician Rating of Depressive Symptoms

Time Frame

Change from baseline at six weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter B Rosenquist, MD

Organizational Affiliation

Augusta University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Augusta University

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Mental Activity During (TMS) Therapy for Depression

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