Mental Activity During (TMS) Therapy for Depression

Not Applicable

Completed

• Conditions: Cognitive Impairment
• Interventions: Behavioral: TMS and non cognitive computer games; Behavioral: TMS and Lumosity®cognitive retraining

• Registration Number: NCT03701932
• Lead Sponsor: Augusta University

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.

Study Timeline

• Study Start: 2015-03-06
• Study First Submitted: 2018-03-26
• Study First Submitted QC: 2018-10-08
• Study First Posted: 2018-10-10
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-27
• Last Update Posted: 2020-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMS and non cognitive computer games	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
TMS and Lumosity® cognitive retraining	TMS and Lumosity®cognitive retraining	Group will receive TMS and will concurrently engage in cognitive retraining exercises comprised of the Lumosity® battery.

Primary Outcome Measures

Name	Time	Method
The University of Pennsylvania Computerized Neuropsychological Testing Battery (Penn CNP)	Change from baseline at six weeks	Administers computerized neuropsychological tests for research studies

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale 17 item	Change from baseline at six weeks	Clinician Rating of Depressive Symptoms
The Lumosity® Brain Performance Test (BPT)	Change from baseline at six weeks	Online neuropsychological battery of assessments measuring training-related changes in Cognitive Performance
Inventory of Depressive Symptoms- Self Report	Change from baseline at six weeks	Patient rating of depressive symptom severity

Trial Locations

Locations (1)

Augusta University; 🇺🇸 Augusta, Georgia, United States