Augmenting rTMS With Cognitive Control Training in Major Depressive Disorder

NCT04317495 | Terminated

• 1 other identifier: HUM00161598
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Conditions

Major Depressive Disorder

Keywords

transcranial magnetic stimulation; computerized cognitive training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time on task during treatment

  For each day: 45 min; for entire treatment: approx 30 days

• Acceptability of CCT

  through study completion date, up to 2 years

• Cognitive Control Performance change over course of treatment

  Approximately 30 days (usually 20-30 sessions)

Study Arms (1)

Computerized Cognitive Training (CCT)

EXPERIMENTAL

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

Other: Computerized Cognitive Training (CCT)

Interventions

Computerized Cognitive Training (CCT) OTHER

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.

Computerized Cognitive Training (CCT)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Stephan Taylor, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 23, 2020
• Study Start: August 27, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)