Bipolar DisorderNCT03338673
Brain Stimulation and Cognitive Training
A study testing tDCS and BrainHQ in people with Bipolar Disorder and Schizo Affective Disorder, run by University of Michigan at 1 site in United States.
Trial summary
People with serious mental illness often report difficulties with thinking skills like memory. These difficulties can make it harder to perform day-to-day activities. The purpose of this study is to test whether combining a type of non-invasive brain stimulation with computerized cognitive exercises is acceptable to… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Bipolar Disorder, Schizo Affective Disorder, Schizophrenia
- What is being tested?
- tDCS and BrainHQ
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2018to 27 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of bipolar disorder I or II, schizoaffective disorder, or schizophrenia
- Objective cognitive impairment in working memory
- Willingness to complete computerized cognitive training and undergo brain stimulation procedures
Who cannot join
- History of neurological illness or brain injury (e.g., stroke)
- History of loss of consciousness
- Diagnosed intellectual disability
- Current substance use disorder
- Current mania or moderate depression or severe psychosis
- Serious suicidal ideation/behavior
- Pregnant or trying to become pregnant, or currently lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromodulation Plus Cognitive Training to Improve Working Memory Among Individuals With Serious Mental Illness.
People with serious mental illness often report difficulties with thinking skills like memory. These difficulties can make it harder to perform day-to-day activities. The purpose of this study is to test whether combining a type of non-invasive brain stimulation with computerized cognitive exercises is acceptable to participants, and whether it is helpful in improving a specific type of memory skill in people who have mental health conditions and memory deficits.
This study is designed so that all participants will get both treatments: the non-invasive brain stimulation and computerized cognitive exercises. Half of the participants will start with both the brain stimulation and the cognitive exercises (dual therapy), and half will start with just the computerized exercises (monotherapy). After three weeks, participants will switch to the other condition: the people who did both treatments first will switch to just the cognitive exercises alone, and the people who started with the cognitive exercises alone will then switch to doing both the brain stimulation and cognitive exercises.
Overall, participants will be in the study for about 7-8 weeks. The brain stimulation treatment involves 10 visits to the clinic over 3 weeks. The computerized cognitive exercises can be done at home, and involve 10 hours of exercises over 3 weeks. Participants will also complete paper-and-pencil assessments at the beginning, middle, and end of treatment.
- Conditions
- Bipolar Disorder, Schizo Affective Disorder, Schizophrenia
- Being tested
- tDCS, BrainHQ
- Medical subject headings
- Bipolar Disorder, Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called Transcranial direct current stimulation
tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function
BrainHQOther
Also called Computerized cognitive exercises
BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
| Study group | Role | What they receive |
|---|---|---|
| Dual Therapy First | Experimental | Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone Receives: Device: tDCS; Other: BrainHQ |
| Mono Therapy First | Experimental | Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises Receives: Device: tDCS; Other: BrainHQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Retention in Combination Treatment
Number of participants completing every session of the combined phase of treatment
Measured: 4 weeks
Participant-rated Acceptability of Combination Therapy
Self-reported satisfaction as indicated on a numerical rating scale (1-10, where higher scores indicate greater satisfaction)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start11 Oct 2018
- Primary completion27 Sep 2019
- Study completion27 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bipolar 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized to receive either dual therapy (cognitive exercises plus brain stimulation) or monotherapy (cognitive exercises alone) first; after 3 weeks participants will switch to the other condition
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Burton, University of Michigan
- Investigators
- Cynthia Burton, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338673
- Sponsor's protocol ID
- HUM00119204
- Status last verified
- Aug 2020
- First submitted
- 6 Nov 2017
- Last updated
- 2 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation Plus Cognitive Training to Improve Working Memory Among Individuals With Serious Mental Illness.
- ClinicalTrials.gov ID
- NCT03338673
- Acronym / sponsor ID
- HUM00119204
- Conditions
- Bipolar Disorder, Schizo Affective Disorder, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 27 Sep 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Posted 2 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with serious mental illness often report difficulties with thinking skills like memory. These difficulties can make it harder to perform day-to-day activities. The purpose of this study is to test whether combining a type of non-invasive brain stimulation with computerized cognitive exercises is acceptable to participants, and whether it is helpful in improving a specific type of memory skill in people who have mental health conditions and memory deficits.
This study is designed so that all participants will get both treatments: the non-invasive brain stimulation and computerized cognitive exercises. Half of the participants will start with both the brain stimulation and the cognitive exercises (dual therapy), and half will start with just the computerized exercises (monotherapy). After three weeks, participants will switch to the other condition: the people who did both treatments first will switch to just the cognitive exercises alone, and the people who started with the cognitive exercises alone will then switch to doing both the brain stimulation and cognitive exercises.
Overall, participants will be in the study for about 7-8 weeks. The brain stimulation treatment involves 10 visits to the clinic over 3 weeks. The computerized cognitive exercises can be done at home, and involve 10 hours of exercises over 3 weeks. Participants will also complete paper-and-pencil assessments at the beginning, middle, and end of treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive either dual therapy (cognitive exercises plus brain stimulation) or monotherapy (cognitive exercises alone) first; after 3 weeks participants will switch to the other condition
| Arm | Type | Receives |
|---|---|---|
| Dual Therapy First | Experimental | Device: tDCS, Other: BrainHQParticipants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone |
| Mono Therapy First | Experimental | Device: tDCS, Other: BrainHQParticipants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of bipolar disorder I or II, schizoaffective disorder, or schizophrenia
- Objective cognitive impairment in working memory
- Willingness to complete computerized cognitive training and undergo brain stimulation procedures
Key exclusion criteria (7 listed)
- History of neurological illness or brain injury (e.g., stroke)
- History of loss of consciousness
- Diagnosed intellectual disability
- Current substance use disorder
- Current mania or moderate depression or severe psychosis
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 |
|---|---|---|
| tDCSAlso: Transcranial direct current stimulationtDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function | Device | Dual Therapy First, Mono Therapy First |
| BrainHQAlso: Computerized cognitive exercisesBrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory | Other | Dual Therapy First, Mono Therapy First |
Primary outcome
Participant Retention in Combination Treatment
Time frame: 4 weeks
Number of participants completing every session of the combined phase of treatment
Participant-rated Acceptability of Combination Therapy
Time frame: 8 weeks
Self-reported satisfaction as indicated on a numerical rating scale (1-10, where higher scores indicate greater satisfaction)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Cynthia Burton, PhD 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 tDCS and BrainHQ in people with Bipolar Disorder and Schizo Affective 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 3 inclusion and 7 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 2 Sep 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?
Yes. Results are posted in the registry (first posted 2 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participant Retention in Combination Treatment (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 2 Sep 2020.