Mental Activity During (TMS) Therapy for Depression

NCT ID: NCT03701932

Last Updated: 2020-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-06

Study Completion Date

2019-07-31

Brief Summary

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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

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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.

Conditions

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Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TMS and Lumosity® cognitive retraining

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

Group Type EXPERIMENTAL

TMS and Lumosity®cognitive retraining

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

TMS and non cognitive computer games

Intervention Type BEHAVIORAL

Subjects will play computer games while receiving TMS treatment.

Interventions

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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.

Intervention Type BEHAVIORAL

TMS and non cognitive computer games

Subjects will play computer games while receiving TMS treatment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lumos Labs, Inc.

INDUSTRY

Sponsor Role collaborator

Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Peter Rosenquist

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter B Rosenquist, MD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Locations

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Augusta University

Augusta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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663245

Identifier Type: -

Identifier Source: org_study_id

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