Mental Activity During (TMS) Therapy for Depression

NCT03701932 | Completed

• 1 other identifier: 663245
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment

Keywords

Depression, Transcranial Magnetic Stimulation (TMS)

Outcome Measures

Primary Outcomes (1)

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

  Administers computerized neuropsychological tests for research studies

  Change from baseline at six weeks

Secondary Outcomes (3)

• The Lumosity® Brain Performance Test (BPT)

  Change from baseline at six weeks

• Inventory of Depressive Symptoms- Self Report

  Change from baseline at six weeks

• Hamilton Depression Rating Scale 17 item

  Change from baseline at six weeks

Study Arms (2)

TMS and Lumosity® cognitive retraining

EXPERIMENTAL

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

Behavioral: TMS and Lumosity®cognitive retraining

TMS and non cognitive computer games

ACTIVE COMPARATOR

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

Interventions

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 Lumosity® cognitive retraining

TMS and non cognitive computer games BEHAVIORAL

Subjects will play computer games while receiving TMS treatment.

TMS and non cognitive computer games

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Augusta University: lead
• Lumos Labs, Inc.: collaborator

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Depression

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Peter B Rosenquist, MD

  Augusta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: October 10, 2018
• Study Start: March 6, 2015
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: August 28, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)