Major Depressive DisorderNCT04317495
Augmenting rTMS With Cognitive Control Training in Major Depressive Disorder
A study testing Computerized Cognitive Training (CCT) in people with Major Depressive Disorder, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Computerized Cognitive Training (CCT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2019to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Augmenting Repetitive Transcranial Magnetic Stimulation (rTMS) With Cognitive Control Training in Major Depressive Disorder (MDD)
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
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Computerized Cognitive Training (CCT)
- Keywords
- transcranial magnetic stimulation, computerized cognitive training
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Computerized Cognitive Training (CCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessed by percentage of CCT sessions completed during rTMS
Percentage CCT sessions completed: (number of sessions completed/number of sessions assigned) X 100
Measured: approximately 30 days (usually 20-30 sessions)
Secondary outcomes (3)
Time on task during treatment
Percentage time on task: (Time engaged with task/total time of task assigned)X100, averaged over all active sessions
Measured: For each day: 45 min; for entire treatment: approx 30 days
Acceptability of CCT
Percentage: (Number of eligible patients accepting CCT/number of patients approached but not accepting CCT) x 100
Measured: through study completion date, up to 2 years
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.
Measured: Approximately 30 days (usually 20-30 sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start27 Aug 2019
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan F. Taylor, University of Michigan
- Investigators
- Stephan Taylor, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317495
- Sponsor's protocol ID
- HUM00161598
- Status last verified
- Apr 2021
- First submitted
- 19 Mar 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Repetitive Transcranial Magnetic Stimulation (rTMS) With Cognitive Control Training in Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT04317495
- Acronym / sponsor ID
- HUM00161598
- Conditions
- Major Depressive Disorder
- Keywords
- transcranial magnetic stimulation, computerized cognitive training
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computerized Cognitive Training (CCT) | Experimental | Other: Computerized Cognitive Training (CCT)The patients will receive CCT during their standard rTMS treatments (after having 5 days of treatment until the pre-taper treatment). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Computerized Cognitive Training (CCT) |
Primary outcome
Feasibility assessed by percentage of CCT sessions completed during rTMS
Time frame: approximately 30 days (usually 20-30 sessions)
Percentage CCT sessions completed: (number of sessions completed/number of sessions assigned) X 100
3 secondary outcomes
Time on task during treatment
Time frame: For each day: 45 min; for entire treatment: approx 30 days
Acceptability of CCT
Time frame: through study completion date, up to 2 years
Cognitive Control Performance change over course of treatment
Time frame: Approximately 30 days (usually 20-30 sessions)
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Taylor, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Cognitive Training (CCT) in people with Major Depressive Disorder, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility assessed by percentage of CCT sessions completed during rTMS (time frame: approximately 30 days (usually 20-30 sessions)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.