search
Back to results

Augmenting rTMS With Cognitive Control Training in Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Cognitive Training (CCT)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Major Depressive Disorder focused on measuring transcranial magnetic stimulation, computerized cognitive training

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Computerized Cognitive Training (CCT)

Arm Description

The patients will receive CCT during their standard rTMS treatments (after having 5 days of treatment until the pre-taper treatment).

Outcomes

Primary Outcome Measures

Feasibility assessed by percentage of CCT sessions completed during rTMS
Percentage CCT sessions completed: (number of sessions completed/number of sessions assigned) X 100

Secondary Outcome Measures

Time on task during treatment
Percentage time on task: (Time engaged with task/total time of task assigned)X100, averaged over all active sessions
Acceptability of CCT
Percentage: (Number of eligible patients accepting CCT/number of patients approached but not accepting CCT) x 100
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.

Full Information

First Posted
March 19, 2020
Last Updated
April 5, 2021
Sponsor
University of Michigan
search

1. Study Identification

Unique Protocol Identification Number
NCT04317495
Brief Title
Augmenting rTMS With Cognitive Control Training in Major Depressive Disorder
Official Title
Augmenting Repetitive Transcranial Magnetic Stimulation (rTMS) With Cognitive Control Training in Major Depressive Disorder (MDD)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
New data has caused the principal investigator to decide that the study no longer makes sense to conduct as it is designed. This is not a suspension of IRB approval.
Study Start Date
August 27, 2019 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
transcranial magnetic stimulation, computerized cognitive training

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computerized Cognitive Training (CCT)
Arm Type
Experimental
Arm Description
The patients will receive CCT during their standard rTMS treatments (after having 5 days of treatment until the pre-taper treatment).
Intervention Type
Other
Intervention Name(s)
Computerized Cognitive Training (CCT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility assessed by percentage of CCT sessions completed during rTMS
Description
Percentage CCT sessions completed: (number of sessions completed/number of sessions assigned) X 100
Time Frame
approximately 30 days (usually 20-30 sessions)
Secondary Outcome Measure Information:
Title
Time on task during treatment
Description
Percentage time on task: (Time engaged with task/total time of task assigned)X100, averaged over all active sessions
Time Frame
For each day: 45 min; for entire treatment: approx 30 days
Title
Acceptability of CCT
Description
Percentage: (Number of eligible patients accepting CCT/number of patients approached but not accepting CCT) x 100
Time Frame
through study completion date, up to 2 years
Title
Cognitive Control Performance change over course of treatment
Description
Average percentage correct trials on n-back working memory task for first 2 sessions minus average percentage correct trials for last 2 sessions.
Time Frame
Approximately 30 days (usually 20-30 sessions)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Taylor, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Augmenting rTMS With Cognitive Control Training in Major Depressive Disorder

We'll reach out to this number within 24 hrs