Augmenting rTMS With Cognitive Control Training in Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

Augmenting Repetitive Transcranial Magnetic Stimulation (rTMS) With Cognitive Control Training in Major Depressive Disorder (MDD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04317495
• Other study ID #: HUM00161598
• Status: Terminated
• Phase: N/A
• Start date: August 27, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: April 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for MDD, but the overall effect sized of the treatment is equivalent to antidepressant pharmacotherapy, and responses are highly variable. Given that rTMS is usually given to patients who have failed pharmacotherapy, a more effective alternative is needed. Therefore, this study will combine computerized cognitive training (CCT) during standard rTMS treatments and assess its feasibility, tolerability, and changes in cognitive control performance and depression symptoms. Participants that agree to the study and meet eligibility will receive standard rTMS (generally 25-36 daily treatments) along with CCT (starting on day 5 of treatment until the pre-taper treatment). In addition, to CCT participants will be asked to complete assessments before and after treatment

Description:

This project will also have a registry for participants that are approached to be in the clinical trial with the CCT but don't wish to be enrolled. Although the registry will be available for these participants, the information entered into this ClinicalTrials.gov registration will reflect the clinical trial portion of this project.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Diagnosis of major depressive disorder
• Eligible to receive and recommended for rTMS for depression
• Willingness to complete computerized cognitive training and undergo brain stimulation procedures
• Must be enrolled as a Michigan Medicine patient and currently receiving TMS treatment as part of your clinical care.

Exclusion Criteria:

• History of serious neurological illness or brain injury (e.g., stroke)
• Poor visual acuity impairing performance on the computerized tasks (eyeglasses must be removed for rTMS treatment, but contacts are permissible)
• Diagnosed intellectual disability
• Inability to manipulate a tablet device while seated in the rTMS chair

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Other:
• Computerized Cognitive Training (CCT)
After having four rTMS sessions without CCT, the patients will perform CCT (starting day 5) during the rTMS session, which typically last from 20-40 minutes. A course of rTMS therapy includes from 25-36 treatments, given daily, until the last 5-6 treatments, given as a 'taper' over 2 weeks. CCT will be paired with rTMS up until the taper begins. In addition, they will have assessments prior to and after the therapy.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility assessed by percentage of CCT sessions completed during rTMS	Percentage CCT sessions completed: (number of sessions completed/number of sessions assigned) X 100	approximately 30 days (usually 20-30 sessions)
Secondary	Time on task during treatment	Percentage time on task: (Time engaged with task/total time of task assigned)X100, averaged over all active sessions	For each day: 45 min; for entire treatment: approx 30 days
Secondary	Acceptability of CCT	Percentage: (Number of eligible patients accepting CCT/number of patients approached but not accepting CCT) x 100	through study completion date, up to 2 years
Secondary	Cognitive Control Performance change over course of treatment	Average percentage correct trials on n-back working memory task for first 2 sessions minus average percentage correct trials for last 2 sessions.	Approximately 30 days (usually 20-30 sessions)