Cognitive ImpairmentNCT03701932
Mental Activity During (TMS) Therapy for Depression
A study testing TMS and Lumosity®cognitive retraining and TMS and non cognitive computer games in people with Cognitive Impairment, run by Augusta University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- TMS and Lumosity®cognitive retraining and TMS and non cognitive computer games
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2015to 31 Jul 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mental Activity During Transcranial Magnetic Stimulation (TMS) Therapy for Depression
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.
Read the detailed 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.
- Conditions
- Cognitive Impairment
- Being tested
- TMS and Lumosity®cognitive retraining, TMS and non cognitive computer games
- Keywords
- Depression, Transcranial Magnetic Stimulation (TMS)
- Medical subject headings
- Cognitive Dysfunction, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMS and Lumosity®cognitive retrainingBehavioural
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 gamesBehavioural
Subjects will play computer games while receiving TMS treatment.
| Study group | Role | What they receive |
|---|---|---|
| TMS and Lumosity® cognitive retraining | Experimental | Group will receive TMS and will concurrently engage in cognitive retraining exercises comprised of the Lumosity® battery. Receives: Behavioral: TMS and Lumosity®cognitive retraining |
| TMS and non cognitive computer games | Active comparator | Group will receive TMS while concurrently engaging in selected computer games from several gaming software that includes Play 101 Games and Hoyle Puzzle and Board Games®. They will also be allowed to spend time on gaming activities of their choice in order to keep them engaged Receives: Behavioral: TMS and non cognitive computer games |
What is being measured
The primary outcome is the main question the study is designed to answer.
The University of Pennsylvania Computerized Neuropsychological Testing Battery (Penn CNP)
Administers computerized neuropsychological tests for research studies
Measured: Change from baseline at six weeks
Secondary outcomes (3)
The Lumosity® Brain Performance Test (BPT)
Online neuropsychological battery of assessments measuring training-related changes in Cognitive Performance
Measured: Change from baseline at six weeks
Inventory of Depressive Symptoms- Self Report
Patient rating of depressive symptom severity
Measured: Change from baseline at six weeks
Hamilton Depression Rating Scale 17 item
Clinician Rating of Depressive Symptoms
Measured: Change from baseline at six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start6 Mar 2015
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- Lumos Labs, Inc.
- Responsible party
- Principal investigator, Peter Rosenquist, Augusta University
- Investigators
- Peter B Rosenquist, MD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701932
- Sponsor's protocol ID
- 663245
- Status last verified
- Aug 2020
- First submitted
- 26 Mar 2018
- Last updated
- 28 Aug 2020
- 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 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Activity During Transcranial Magnetic Stimulation (TMS) Therapy for Depression
- ClinicalTrials.gov ID
- NCT03701932
- Acronym / sponsor ID
- 663245
- Conditions
- Cognitive Impairment
- Keywords
- Depression, Transcranial Magnetic Stimulation (TMS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- Lumos Labs, Inc.
- Study start
- 6 Mar 2015 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 10 Oct 2018 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMS and Lumosity® cognitive retraining | Experimental | Behavioral: TMS and Lumosity®cognitive retrainingGroup will receive TMS and will concurrently engage in cognitive retraining exercises comprised of the Lumosity® battery. |
| TMS and non cognitive computer games | Active comparator | Behavioral: TMS and non cognitive computer gamesGroup will receive TMS while concurrently engaging in selected computer games from several gaming software that includes Play 101 Games and Hoyle Puzzle and Board Games®. They will also be allowed to spend time on gaming activities of their choice in order to keep them engaged |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Subject has a diagnosis of depression
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| TMS and Lumosity®cognitive retrainingThe Lumosity® training includes exercises for speed, memory, attention, flexibility, and problem solving. Subjects will complete this battery while receiving TMS treatment. | Behavioural | TMS and Lumosity® cognitive retraining |
| TMS and non cognitive computer gamesSubjects will play computer games while receiving TMS treatment. | Behavioural | TMS and non cognitive computer games |
Primary outcome
The University of Pennsylvania Computerized Neuropsychological Testing Battery (Penn CNP)
Time frame: Change from baseline at six weeks
Administers computerized neuropsychological tests for research studies
3 secondary outcomes
The Lumosity® Brain Performance Test (BPT)
Time frame: Change from baseline at six weeks
Inventory of Depressive Symptoms- Self Report
Time frame: Change from baseline at six weeks
Hamilton Depression Rating Scale 17 item
Time frame: Change from baseline at six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- 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.
Peter B Rosenquist, MD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS and Lumosity®cognitive retraining and TMS and non cognitive computer games in people with Cognitive Impairment, run by Augusta University 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 28 Aug 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The University of Pennsylvania Computerized Neuropsychological Testing Battery (Penn CNP) (time frame: Change from baseline at six weeks). 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 28 Aug 2020.