Schizophrenia, Schizo Affective Disorder, Bipolar Disorder
Conditions
Brief summary
People with serious mental illness often experience 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 helpful in improving a specific type of memory skill in people who have mental health conditions. The study is a randomized clinical trial, meaning that participants will be randomly assigned to receive either 'active' or 'inactive' brain stimulation. All participants will complete computerized cognitive exercises, also known as cognitive training. Overall, participants will be in the study for 6-8 weeks. The study involves 10 visits to the clinic over 2-4 weeks for cognitive training and either active or inactive brain stimulation. Participants will also complete paper-and-pencil assessments at the beginning and end of treatment, and one month after treatment ends.
Interventions
DEVICEtDCS (Active)
tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the experimental arm will receive a steady current delivery through the device.
BEHAVIORALBrainHQ
BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
DEVICEtDCS (Inactive)
tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the sham arm will wear the device but will not receive a steady current delivery.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of bipolar disorder I or II, schizoaffective disorder, or schizophrenia * Willingness to participate in study procedures
Exclusion criteria
* History of neurological illness or injury (e.g., stroke) * History of loss of consciousness * Diagnosed intellectual disability * Current substance use disorder * Current mania or moderate depression or severe psychosis * Current serious suicidal ideation/behavior * Pregnant or trying to become pregnant, or currently lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Letter-number Span Total Score | Baseline to post-treatment (up to 4 weeks) | MCCB letter-number span total raw score. Letter-number span is a subtest of the standardized MCCB and a measure of verbal working memory. Examinees must reorder sequences of numbers and letters spoken out loud by the examiner. Correct responses are counted to create a total score (0-24, where higher scores indicate better performance). For change scores, a positive value indicates improvement (i.e., higher total score). |
| Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Spatial Span Total Score | Baseline to post-treatment (up to 4 weeks) | MCCB spatial span total raw score. Spatial span is a subtest of the standardized MCCB and a measure of visual working memory. Examinees must tap sequences of blocks in the same order as the examiner then in reverse. Correct responses are summed for the forward and backward condition to create a total raw score (0-32, where higher scores indicate better performance).For change scores, a positive value indicates improvement (i.e., higher total score). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Non-Working Memory Comparison Measures - MCCB Trail Making Test, Part A | Baseline to post-treatment (up to 4 weeks) | The Trail Making Test, part A is a subtest of the standardized MCCB and a measure of visuomotor processing/sequencing speed. Examinees must draw a line connecting numbers in ascending order as quickly as possible. Completion time in seconds is recorded (0-120, where lower scores represent better performance). For change scores, a positive value indicates improvement (i.e., faster completion time). |
| Change in Non-Working Memory Comparison Measures - Trail Making Test, Part B | Baseline to post-treatment (up to 4 weeks) | Trail Making Test, part B is not part of the standardized MCCB, but is commonly administered alongside part A as a measure of speeded visuomotor switching/flexibility. Examinees must draw a line connecting numbers and letters in alternating order (e.g., 1-A-2-B). Completion time in seconds is recorded (0-300, where lower scores represent better performance). For change scores, a positive value indicates improvement (i.e., faster completion time). |
Countries
United States
Participant flow
Pre-assignment details
Two participants did not meet the inclusion criteria and were excluded from further participation (i.e., screen failures). Two participants withdrew from the study after enrollment and prior to randomization. Therefore, 19 participants were enrolled and 15 were assigned.
Participants by arm
| Arm | Count |
|---|---|
| Active Stimulation + Cognitive Training Participants receive 10 sessions of 'active' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
tDCS (Active): tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the experimental arm will receive a steady current delivery through the device.
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory | 8 |
| Inactive Stimulation + Cognitive Training Participants receive 10 sessions of 'inactive' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
tDCS (Inactive): tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the sham arm will wear the device but will not receive a steady current delivery. | 7 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Inactive Stimulation + Cognitive Training | Total | Active Stimulation + Cognitive Training |
|---|---|---|---|
| Age, Continuous | 34.71 years STANDARD_DEVIATION 11.43 | 33.07 years STANDARD_DEVIATION 9.7 | 31.63 years STANDARD_DEVIATION 8.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 14 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| MCCB letter-number span total score | 15.43 points on a scale STANDARD_DEVIATION 3.6 | 15.40 points on a scale STANDARD_DEVIATION 3.36 | 15.38 points on a scale STANDARD_DEVIATION 3.38 |
| MCCB spatial span total score | 15.57 points on a scale STANDARD_DEVIATION 4.65 | 16.47 points on a scale STANDARD_DEVIATION 3.76 | 17.25 points on a scale STANDARD_DEVIATION 2.87 |
| MCCB Trail Making Test, part A | 23.14 seconds STANDARD_DEVIATION 4.98 | 22.80 seconds STANDARD_DEVIATION 5.41 | 22.50 seconds STANDARD_DEVIATION 6.09 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 13 Participants | 7 Participants |
| Region of Enrollment United States | 7 Participants | 15 Participants | 8 Participants |
| Sex/Gender, Customized Man | 2 Participants | 5 Participants | 3 Participants |
| Sex/Gender, Customized Non-binary | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Woman | 5 Participants | 9 Participants | 4 Participants |
| Trail Making Test, part B | 72.71 seconds STANDARD_DEVIATION 24.94 | 66.20 seconds STANDARD_DEVIATION 19.35 | 60.50 seconds STANDARD_DEVIATION 11.67 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 1 / 8 | 0 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 |
Outcome results
Primary
Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Letter-number Span Total Score
MCCB letter-number span total raw score. Letter-number span is a subtest of the standardized MCCB and a measure of verbal working memory. Examinees must reorder sequences of numbers and letters spoken out loud by the examiner. Correct responses are counted to create a total score (0-24, where higher scores indicate better performance). For change scores, a positive value indicates improvement (i.e., higher total score).
Time frame: Baseline to post-treatment (up to 4 weeks)
Population: Four participants withdrew from the study before post-treatment assessment and were not included in the analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Stimulation + Cognitive Training | Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Letter-number Span Total Score | 0.40 score on a scale | Standard Deviation 1.67 |
| Inactive Stimulation + Cognitive Training | Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Letter-number Span Total Score | 0.50 score on a scale | Standard Deviation 1.64 |
Comparison: Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)p-value: 0.923ANOVA
Primary
Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Spatial Span Total Score
MCCB spatial span total raw score. Spatial span is a subtest of the standardized MCCB and a measure of visual working memory. Examinees must tap sequences of blocks in the same order as the examiner then in reverse. Correct responses are summed for the forward and backward condition to create a total raw score (0-32, where higher scores indicate better performance).For change scores, a positive value indicates improvement (i.e., higher total score).
Time frame: Baseline to post-treatment (up to 4 weeks)
Population: Four participants withdrew from the study before post-treatment assessment and were not included in the analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Stimulation + Cognitive Training | Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Spatial Span Total Score | 1.60 score on a scale | Standard Deviation 0.89 |
| Inactive Stimulation + Cognitive Training | Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Spatial Span Total Score | 0.17 score on a scale | Standard Deviation 1.6 |
Comparison: Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)p-value: 0.11ANOVA
Secondary
Change in Non-Working Memory Comparison Measures - MCCB Trail Making Test, Part A
The Trail Making Test, part A is a subtest of the standardized MCCB and a measure of visuomotor processing/sequencing speed. Examinees must draw a line connecting numbers in ascending order as quickly as possible. Completion time in seconds is recorded (0-120, where lower scores represent better performance). For change scores, a positive value indicates improvement (i.e., faster completion time).
Time frame: Baseline to post-treatment (up to 4 weeks)
Population: Four participants withdrew from the study before post-treatment assessment and were not included in the analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Stimulation + Cognitive Training | Change in Non-Working Memory Comparison Measures - MCCB Trail Making Test, Part A | 1.40 seconds | Standard Deviation 5.55 |
| Inactive Stimulation + Cognitive Training | Change in Non-Working Memory Comparison Measures - MCCB Trail Making Test, Part A | 2.33 seconds | Standard Deviation 7.17 |
Comparison: Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)p-value: 0.818ANOVA
Secondary
Change in Non-Working Memory Comparison Measures - Trail Making Test, Part B
Trail Making Test, part B is not part of the standardized MCCB, but is commonly administered alongside part A as a measure of speeded visuomotor switching/flexibility. Examinees must draw a line connecting numbers and letters in alternating order (e.g., 1-A-2-B). Completion time in seconds is recorded (0-300, where lower scores represent better performance). For change scores, a positive value indicates improvement (i.e., faster completion time).
Time frame: Baseline to post-treatment (up to 4 weeks)
Population: Four participants withdrew from the study before post-treatment assessment and were not included in the analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Stimulation + Cognitive Training | Change in Non-Working Memory Comparison Measures - Trail Making Test, Part B | 3.60 seconds | Standard Deviation 12.82 |
| Inactive Stimulation + Cognitive Training | Change in Non-Working Memory Comparison Measures - Trail Making Test, Part B | 19.50 seconds | Standard Deviation 17.76 |
Comparison: Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)p-value: 0.13ANOVA