Mental Activity During (TMS) Therapy for Depression

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03701932
• Other study ID #: 663245
• Status: Completed
• Phase: N/A
• Start date: March 6, 2015
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2020
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Cognitive Impairment
• Depression

Intervention

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.
• TMS and non cognitive computer games
Subjects will play computer games while receiving TMS treatment.

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Augusta University	Lumos Labs, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The University of Pennsylvania Computerized Neuropsychological Testing Battery (Penn CNP)	Administers computerized neuropsychological tests for research studies	Change from baseline at six weeks
Secondary	The Lumosity® Brain Performance Test (BPT)	Online neuropsychological battery of assessments measuring training-related changes in Cognitive Performance	Change from baseline at six weeks
Secondary	Inventory of Depressive Symptoms- Self Report	Patient rating of depressive symptom severity	Change from baseline at six weeks
Secondary	Hamilton Depression Rating Scale 17 item	Clinician Rating of Depressive Symptoms	Change from baseline at six weeks