Transcranial Direct Current StimulationMINUTESNCT03896438
Maximizing the Impact of Neuroplasticity Using Transcranial Electrical Stimulation Study 2
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Transcranial Direct Current Stimulation and Schizophrenia, run by University of Minnesota at 1 site in United States.
Trial summary
Non-invasive neuromodulation, such as transcranial direct current stimulation ( tDCS) , is emerging as an important therapeutic tool with documented effects on brain circuitry, yet little is understood about h ow it changes cognition. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Transcranial Direct Current Stimulation, Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 30 May 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ability to provide consent and comply with study procedures.
- Age 18 - 60 years old.
- Estimated IQ range within the range: 70 ≤ IQ ≤ 115.
- Schizophrenia or schizoaffective disorder as assessed by the MINI (Mini International Neuropsychiatric Interview)(Sheehan et al., 1998).
- Not having a current addictive disorder as measured by MINI (Mini International Neuropsychiatric Interview), or a sleep disorder.
- Ability to participate in three weekly 45' training sessions over 12 weeks and participate in four assessments.
- Clinically stable and on stable medications for at least one month before start of study.
Who cannot join
- Any medical condition or treatment with neurological sequelae (e.g. stroke, tumor, loss of consciousness > 30 min, HIV).
- Contraindications for tDCS or MRI scanning (tDCS contraindication: history of seizures; MRI contraindications: The research team will utilize the CMRR Center's screening tools and adhere to the screening SOP during enrollment of all research participants in this protocol. The CMRR Center's screening tools and SOP are IRB approved under the CMRR Center Grant (HSC# 1406M51205) and information regarding screening procedures is publicly available on the CMRR website (CMRR Policies / Procedures).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Increased Thalamocortical Connectivity in Tdcs-potentiated Generalization of Cognitive Training
Non-invasive neuromodulation, such as transcranial direct current stimulation ( tDCS) , is emerging as an important therapeutic tool with documented effects on brain circuitry, yet little is understood about h ow it changes cognition. In particular, tDCS may have a critical role to play in generalization, that is how training in one domain generalizes to unlearned or unpracticed domains. This problem has resonance for disorders with cognitive deficits, such as schizophrenia.
Understanding how tDCS affects brain circuity is critical to the design and application of effective interventions, especially if the effects are different for healthy vs. psychiatric populations. In previous research, one clue to the mechanism underlying increased learning and generalization with tDCS was provided by neuroimaging data from subjects with schizophrenia undergoing cognitive training where increases in thalamocortical (prefrontal) functional connectivity (FC) predicted greater generalization.
Read more
The premise of this proposal is that increases in thalamocortical FC are associated with the generalization of cognitive training, and tDCS facilitates these increases. The overarching goals of this proposal are to deploy neuroimaging and cognitive testing to understand how tDCS with cognitive training affect thalamocortical circuitry in individuals with and without psychosis and to examine variability in response within both groups.
Study 1(NCT03896425) will compare right prefrontal, left prefrontal and sham tDCS during concurrent cognitive training over 12 weeks in 90 healthy controls. Study 2 will be similar in all aspects but will examine 90 patients with schizophrenia or schizoaffective disorder and include clinical assessments. Results of the study will provide crucial information about location of stimulation, length of treatment, modeled dosage, trajectory and durability needed to guide future research and interventions for cognitive impairments.
- Being tested
- Transcranial Direct Current Stimulation (tDCS)
- Keywords
- tDCS, cognitive training, functional connectivity
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Device
Three different stimulation montages will be programmed: right, left and sham. During the Ramp periods, 2 mA current will be delivered to both AF3 and AF4 with an ascending (RampUp) and descending ramp (RampDown) over 30 sec via two saline soaked electrode sponges (~ 25cm²; current density = 0.08 mA/cm²). In this way, all subjects experience the same sensation on both sides to blind them to condition. During the Constant period, current will be set based on the Condition: Right - 2mA AF4 anode-AF3 cathode; Left - 2mA applied to AF3 anode-AF4 cathode; Sham - current turned off.
| Study group | Role | What they receive |
|---|---|---|
| right active-tDCS | Experimental | 2-3 times/week for 12 weeks: ramp-up for 30 seconds, 2mA right (AF4 anode - AF3 cathode) for 20 min, and then ramp-down for 30 seconds. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
| left active-tDCS | Experimental | 2-3 times/week for 12 weeks: ramp-up for 30 seconds, 2mA left (AF3 anode - AF4 cathode) for 20 min, and then ramp-down for 30 seconds. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
| sham tDCS | Sham comparator | Current will be turned off immediately after the initial 30-second ramp-up period. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Thalamocortical Functional Connectivity (FC)
Most participants completed MRI sessions on a 3T scanner located in the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota. FC measures how different brain regions change in activation together. We characterized FC using global connectivity from graph theory analysis. We extracted the fMRI time courses from 454 parcellations defined by the 400 S4 Schaefer Atlas (Schaefer et al., 2018) combined with the Melbourne Subcortex Atlas (Tian et al., 2020). We computed the absolute value of the Pearson's correlation for all possible pairs of time series, creating a 454x454 (N x N) connectivity matrix, which was then reduced to 10% most significant connections by subject. We estimated the FC by calculating the node strength for each parcellation, which is the weighted mean of all significant connections, from these connectivity matrices. Finally, we averaged node strength across parcellations to calculate global node strength. Higher values indicate more brain-wide FC.
Measured: baseline
Changes in Task-dependent Thalamocortical Functional Connectivity (fMRI) During the N-back Task.
Task-dependent thalamocortical connectivity associated with the N-back task was calculated by modeling the block task design together with the thalamic regressor using psychophysiological interaction analysis (PPI). The thalamic regressor is the time series of the mediodorsal thalamus from the Melbourne atlas. The primary analysis focused on the 2-back conditions alone. The PPI analysis calculates the functional connectivity between the mediodorsal thalamus and all other brain regions specifically during 2-back trials. Neural activation related to the thalamic regressor was compared to neural activation during the fixation (no choices made) to normalize the relative activation (z-score). Positive values indicate increased functional connectivity with the thalamus during the 2-back choices. A z-score of zero represents no difference compared to the fixation cross (no choices). We report the average z-score of the PPI regressor within the control network (Yeo et al., 2011).
Measured: baseline
Changes in Task-dependent Thalamocortical Functional Connectivity (fMRI) During the DPX Task.
Task-dependent thalamocortical connectivity associated with the Dot Pattern Expectancy (DPX) task demands will be identified by analyzing cue and probe events together with the thalamic regressor using psychophysiological interaction analysis (PPI). The thalamic regressor is the time series of the mediodorsal thalamus from the Melbourne atlas. We examined B-cue related connectivity. The PPI analysis calculates the functional connectivity between the mediodorsal thalamus and all other brain regions specifically during B-cue trials. Neural activation related to the thalamic regressor was compared to neural activation during the fixation (no choices made) to normalize the relative activation (z-score). Positive values indicate increased functional connectivity with the thalamus during the B-cue responses. A z-score of zero represents no difference compared to the fixation cross (no choices). We report the average z-score of the PPI regressor within the control network.
Measured: baseline
Change in N-back Performance
The n-back task measures working memory capacity. The participant is presented with a series of stimuli and instructed to indicate with a button press when the current stimulus matches the stimulus that appeared a pre-determined number (n) of trials before. d' (d prime) will be calculated as a measure of signal detection, which indicates the normalized rate of hits to false positives (d' = z(H) - z(F)). Increase in d' signifies improved signal detection, i.e. a better outcome. A d' near zero indicates a performance at chance, i.e., a poor performance. The range is -4.65 to 4.65
Measured: baseline
Change in DPX Performance
The Dot Pattern Expectancy (DPX) task is an adaptation of the expectancy AX task that uses pairs of simple dot patterns rather than letter pairs as stimuli. The DPX task will be performed in 3 blocks. Each trial consists of a cue dot pattern followed by a probe dot pattern. Different combinations of cues and probes enable the identification of a specific deficit in a subject's ability to maintain goal-relevant information throughout a trial. Timing will be jittered and each block of the DPX task will consist of 40 trials: 24 AX (60%), 6 AY (15%), 6 BX (15%) and 4 BY (10%). Each block will last 6 minutes. d'-context will be calculated as a measure of signal detection, which indicates the normalized rate of AX hits to BX false positives (d' = z(H) - z(F)). Increase in d' -context signified improved signal detection, i.e. a better outcome. A d' near zero indicates a performance at chance, i.e., a poor performance. The range is -4.65 to 4.65.
Measured: baseline
Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite Score
Intends to provide a relatively brief evaluation of key cognitive domains relevant to schizophrenia and related disorders. The composite score is reported as a T-score, with a mean of 50 and standard deviation of 10. Higher values indicate greater cognitive functioning.
Measured: baseline
Changes in Thalamocortical Functional Connectivity (FC)
Most participants completed MRI sessions on a 3T scanner located in the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota. FC measures how different brain regions change in activation together. We characterized FC using global connectivity from graph theory analysis. We extracted the fMRI time courses from 454 parcellations defined by the 400 S4 Schaefer Atlas (Schaefer et al., 2018) combined with the Melbourne Subcortex Atlas (Tian et al., 2020). We computed the absolute value of the Pearson's correlation for all possible pairs of time series, creating a 454x454 (N x N) connectivity matrix, which was then reduced to 10% most significant connections by subject. We estimated the FC by calculating the node strength for each parcellation, which is the weighted mean of all significant connections, from these connectivity matrices. Finally, we averaged node strength across parcellations to calculate global node strength. Higher values indicate more brain-wide FC.
Measured: mid-test (week 6)
Changes in Thalamocortical Functional Connectivity (FC)
Most participants completed MRI sessions on a 3T scanner located in the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota. FC measures how different brain regions change in activation together. We characterized FC using global connectivity from graph theory analysis. We extracted the fMRI time courses from 454 parcellations defined by the 400 S4 Schaefer Atlas (Schaefer et al., 2018) combined with the Melbourne Subcortex Atlas (Tian et al., 2020). We computed the absolute value of the Pearson's correlation for all possible pairs of time series, creating a 454x454 (N x N) connectivity matrix, which was then reduced to 10% most significant connections by subject. We estimated the FC by calculating the node strength for each parcellation, which is the weighted mean of all significant connections, from these connectivity matrices. Finally, we averaged node strength across parcellations to calculate global node strength. Higher values indicate more brain-wide FC.
Measured: post-test (week 12)
Changes in Task-dependent Thalamocortical Functional Connectivity (fMRI) During the N-back Task.
Task-dependent thalamocortical connectivity associated with the N-back task was calculated by modeling the block task design together with the thalamic regressor using psychophysiological interaction analysis (PPI). The thalamic regressor is the time series of the mediodorsal thalamus from the Melbourne atlas. The primary analysis focused on the 2-back conditions alone. The PPI analysis calculates the functional connectivity between the mediodorsal thalamus and all other brain regions specifically during 2-back trials. Neural activation related to the thalamic regressor was compared to neural activation during the fixation (no choices made) to normalize the relative activation (z-score). Positive values indicate increased functional connectivity with the thalamus during the 2-back choices. A z-score of zero represents no difference compared to the fixation cross (no choices). We report the average z-score of the PPI regressor within the control network (Yeo et al., 2011).
Measured: mid-test (week 6)
Changes in Task-dependent Thalamocortical Functional Connectivity (fMRI) During the N-back Task.
Task-dependent thalamocortical connectivity associated with the N-back task was calculated by modeling the block task design together with the thalamic regressor using psychophysiological interaction analysis (PPI). The thalamic regressor is the time series of the mediodorsal thalamus from the Melbourne atlas. The primary analysis focused on the 2-back conditions alone. The PPI analysis calculates the functional connectivity between the mediodorsal thalamus and all other brain regions specifically during 2-back trials. Neural activation related to the thalamic regressor was compared to neural activation during the fixation (no choices made) to normalize the relative activation (z-score). Positive values indicate increased functional connectivity with the thalamus during the 2-back choices. A z-score of zero represents no difference compared to the fixation cross (no choices). We report the average z-score of the PPI regressor within the control network (Yeo et al., 2011).
Measured: post-test (week 12)
Changes in Task-dependent Thalamocortical Functional Connectivity (fMRI) During the DPX Task.
PPI regressor (z-score) within Control Network associated with B-cue Task-dependent thalamocortical connectivity associated with the DPX task demands will be identified by analyzing cue and probe events together with the thalamic regressor using psychophysiological interaction analysis (PPI). The thalamic regressor is the time series of the mediodorsal thalmus from the Melbourne atlas (THA-DAm; Tian et al., 2020). Preliminary analysis for the DPX task will examine B-cue related connectivity alone. We report the average z-score of the PPI regressor within the control network (Yeo et al., 2011). Neural activation was normed to calculated z-scores, such that postive values indicate increased connectivity with the thalamus, and negative values indicate decreased connectivity with the thalamus.
Measured: mid-test (week 6)
Changes in Task-dependent Thalamocortical Functional Connectivity (fMRI) During the DPX Task.
PPI regressor (z-score) within Control Network associated with B-cue Task-dependent thalamocortical connectivity associated with the DPX task demands will be identified by analyzing cue and probe events together with the thalamic regressor using psychophysiological interaction analysis (PPI). The thalamic regressor is the time series of the mediodorsal thalmus from the Melbourne atlas (THA-DAm; Tian et al., 2020). Preliminary analysis for the DPX task will examine B-cue related connectivity alone. We report the average z-score of the PPI regressor within the control network (Yeo et al., 2011). Neural activation was normed to calculated z-scores, such that postive values indicate increased connectivity with the thalamus, and negative values indicate decreased connectivity with the thalamus.
Measured: post-test (week 12)
Change in N-back Performance
The n-back task measures working memory capacity. The participant is presented with a series of stimuli and instructed to indicate with a button press when the current stimulus matches the stimulus that appeared a pre-determined number (n) of trials before. d' (d prime) will be calculated as a measure of signal detection, which indicates the normalized rate of hits to false positives (d' = z(H) - z(F)). Increase in d' signifies improved signal detection, i.e. a better outcome. A d' near zero indicates a performance at chance, i.e., a poor performance. The range is -4.65 to 4.65
Measured: mid-test (week 6)
Change in N-back Performance
The n-back task measures working memory capacity. The participant is presented with a series of stimuli and instructed to indicate with a button press when the current stimulus matches the stimulus that appeared a pre-determined number (n) of trials before. d' (d prime) will be calculated as a measure of signal detection, which indicates the normalized rate of hits to false positives (d' = z(H) - z(F)). Increase in d' signifies improved signal detection, i.e. a better outcome. A d' near zero indicates a performance at chance, i.e., a poor performance. The range is -4.65 to 4.65
Measured: post-test (week 12)
Change in DPX Performance
The Dot Pattern Expectancy (DPX) task is an adaptation of the expectancy AX task that uses pairs of simple dot patterns rather than letter pairs as stimuli. The DPX task will be performed in 3 blocks. Each trial consists of a cue dot pattern followed by a probe dot pattern. Different combinations of cues and probes enable the identification of a specific deficit in a subject's ability to maintain goal-relevant information throughout a trial. Timing will be jittered and each block of the DPX task will consist of 40 trials: 24 AX (60%), 6 AY (15%), 6 BX (15%) and 4 BY (10%). Each block will last 6 minutes. d'-context will be calculated as a measure of signal detection, which indicates the normalized rate of AX hits to BX false positives (d' = z(H) - z(F)). Increase in d' -context signified improved signal detection, i.e. a better outcome. A d' near zero indicates a performance at chance, i.e., a poor performance. The range is -4.65 to 4.65.
Measured: mid-test (week 6)
Change in DPX Performance
The Dot Pattern Expectancy (DPX) task is an adaptation of the expectancy AX task that uses pairs of simple dot patterns rather than letter pairs as stimuli. The DPX task will be performed in 3 blocks. Each trial consists of a cue dot pattern followed by a probe dot pattern. Different combinations of cues and probes enable the identification of a specific deficit in a subject's ability to maintain goal-relevant information throughout a trial. Timing will be jittered and each block of the DPX task will consist of 40 trials: 24 AX (60%), 6 AY (15%), 6 BX (15%) and 4 BY (10%). Each block will last 6 minutes. d'-context will be calculated as a measure of signal detection, which indicates the normalized rate of AX hits to BX false positives (d' = z(H) - z(F)). Increase in d' -context signified improved signal detection, i.e. a better outcome. A d' near zero indicates a performance at chance, i.e., a poor performance. The range is -4.65 to 4.65.
Measured: post-test (week 12)
Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite Score
MCCB Composite T-Score Intends to provide a relatively brief evaluation of key cognitive domains relevant to schizophrenia and related disorders. The composite score is reported as a T-score, with a mean of 50 and standard deviation of 10. Higher values indicate greater cognitive functioning.
Measured: mid-test (week 6)
Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite Score
MCCB Composite T-Score Intends to provide a relatively brief evaluation of key cognitive domains relevant to schizophrenia and related disorders. The composite score is reported as a T-score, with a mean of 50 and standard deviation of 10. Higher values indicate greater cognitive functioning.
Measured: post-test (week 12)
Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite Score
MCCB Composite T-Score Intends to provide a relatively brief evaluation of key cognitive domains relevant to schizophrenia and related disorders. The composite score is reported as a T-score, with a mean of 50 and standard deviation of 10. Higher values indicate greater cognitive functioning.
Measured: follow-up (week 24)
Secondary outcomes (12)
Change in University of California San Diego Performance-Based Skills Assessment - Brief (UPSA-B)
Measures functional capacity by assessing skills involved in everyday tasks important to daily living. Points are scored for each of two sub scales based on the participant's correct performance of items in the sub scale (incorrect: 0 points, correct: 1 or 2 points). Points are used to derive a sub scale score by dividing points scored by the number of items in the sub scale (percentage correct) and multiplied by 50. The two sub scale scores are then added to derive the total score, with a possible range of 0-100. Higher scores represent better outcomes.
Measured: baseline
Change in Brief Psychiatric Rating Scale (BPRS) Score
Measures symptom severity in patients with schizophrenia. Scores are assigned for symptom categories based on a semi-structured clinical interview with anchored severity scales (1-7) for each symptom category. Total score is derived by adding up individual symptom scores, resulting in a total score range of 24-168. Higher scores indicate greater symptom severity. A decrease in scores over time would indicate symptom reduction, i.e. a better outcome.
Measured: baseline
Change in Brief Negative Symptom Scale (BNSS) Score
Measures of symptom severity in patients with schizophrenia with an emphasis on negative symptoms. Scores are assigned to symptom categories based on a semi-structured clinical interview with anchored severity scales (0-6 or 0-9). Total score is derived by adding up individual symptom scores, resulting in a total score range of 0-90. Higher scores indicate greater symptom severity. A decrease in scores over time would indicate symptom reduction, i.e. a better outcome.
Measured: baseline
Change in University of California San Diego Performance-Based Skills Assessment - Brief (UPSA-B)
Measures functional capacity by assessing skills involved in everyday tasks important to daily living. Points are scored for each of two sub scales based on the participant's correct performance of items in the sub scale (incorrect: 0 points, correct: 1 or 2 points). Points are used to derive a sub scale score by dividing points scored by the number of items in the sub scale (percentage correct) and multiplied by 50. The two sub scale scores are then added to derive the total score, with a possible range of 0-100. Higher scores represent better outcomes.
Measured: mid-test (week 6)
Change in University of California San Diego Performance-Based Skills Assessment - Brief (UPSA-B)
Measures functional capacity by assessing skills involved in everyday tasks important to daily living. Points are scored for each of two sub scales based on the participant's correct performance of items in the sub scale (incorrect: 0 points, correct: 1 or 2 points). Points are used to derive a sub scale score by dividing points scored by the number of items in the sub scale (percentage correct) and multiplied by 50. The two sub scale scores are then added to derive the total score, with a possible range of 0-100. Higher scores represent better outcomes.
Measured: post-test (week 12)
Change in University of California San Diego Performance-Based Skills Assessment - Brief (UPSA-B)
Measures functional capacity by assessing skills involved in everyday tasks important to daily living. Points are scored for each of two sub scales based on the participant's correct performance of items in the sub scale (incorrect: 0 points, correct: 1 or 2 points). Points are used to derive a sub scale score by dividing points scored by the number of items in the sub scale (percentage correct) and multiplied by 50. The two sub scale scores are then added to derive the total score, with a possible range of 0-100. Higher scores represent better outcomes.
Measured: follow-up (week 24)
Change in Brief Psychiatric Rating Scale (BPRS) Score
Measures symptom severity in patients with schizophrenia. Scores are assigned for symptom categories based on a semi-structured clinical interview with anchored severity scales (1-7) for each symptom category. Total score is derived by adding up individual symptom scores, resulting in a total score range of 24-168. Higher scores indicate greater symptom severity. A decrease in scores over time would indicate symptom reduction, i.e. a better outcome.
Measured: mid-test (week 6)
Change in Brief Psychiatric Rating Scale (BPRS) Score
Measures symptom severity in patients with schizophrenia. Scores are assigned for symptom categories based on a semi-structured clinical interview with anchored severity scales (1-7) for each symptom category. Total score is derived by adding up individual symptom scores, resulting in a total score range of 24-168. Higher scores indicate greater symptom severity. A decrease in scores over time would indicate symptom reduction, i.e. a better outcome.
Measured: post-test (week 12)
Change in Brief Psychiatric Rating Scale (BPRS) Score
Measures symptom severity in patients with schizophrenia. Scores are assigned for symptom categories based on a semi-structured clinical interview with anchored severity scales (1-7) for each symptom category. Total score is derived by adding up individual symptom scores, resulting in a total score range of 24-168. Higher scores indicate greater symptom severity. A decrease in scores over time would indicate symptom reduction, i.e. a better outcome.
Measured: follow-up (week 24)
Change in Brief Negative Symptom Scale (BNSS) Score
Measures of symptom severity in patients with schizophrenia with an emphasis on negative symptoms. Scores are assigned to symptom categories based on a semi-structured clinical interview with anchored severity scales (0-6 or 0-9). Total score is derived by adding up individual symptom scores, resulting in a total score range of 0-90. Higher scores indicate greater symptom severity. A decrease in scores over time would indicate symptom reduction, i.e. a better outcome.
Measured: Mid-test (week 6)
Change in Brief Negative Symptom Scale (BNSS) Score
Measures of symptom severity in patients with schizophrenia with an emphasis on negative symptoms. Scores are assigned to symptom categories based on a semi-structured clinical interview with anchored severity scales (0-6 or 0-9). Total score is derived by adding up individual symptom scores, resulting in a total score range of 0-90. Higher scores indicate greater symptom severity. A decrease in scores over time would indicate symptom reduction, i.e. a better outcome.
Measured: post-test (week 12)
Change in Brief Negative Symptom Scale (BNSS) Score
Measures of symptom severity in patients with schizophrenia with an emphasis on negative symptoms. Scores are assigned to symptom categories based on a semi-structured clinical interview with anchored severity scales (0-6 or 0-9). Total score is derived by adding up individual symptom scores, resulting in a total score range of 0-90. Higher scores indicate greater symptom severity. A decrease in scores over time would indicate symptom reduction, i.e. a better outcome.
Measured: follow-up (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start1 Jul 2019
- Primary completion30 May 2023
- Study completion30 May 2023
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 Transcranial Direct Current StimulationStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896438
- Sponsor's protocol ID
- PSYCH-2018-26586_02
- Other IDs
- 1RF1MH116987-01
- Acronym
- MINUTES
- Status last verified
- Aug 2024
- First submitted
- 25 Mar 2019
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Thalamocortical Connectivity in Tdcs-potentiated Generalization of Cognitive Training
- ClinicalTrials.gov ID
- NCT03896438
- Acronym / sponsor ID
- MINUTES / PSYCH-2018-26586_02
- Keywords
- tDCS, cognitive training, functional connectivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-invasive neuromodulation, such as transcranial direct current stimulation ( tDCS) , is emerging as an important therapeutic tool with documented effects on brain circuitry, yet little is understood about h ow it changes cognition. In particular, tDCS may have a critical role to play in generalization, that is how training in one domain generalizes to unlearned or unpracticed domains. This problem has resonance for disorders with cognitive deficits, such as schizophrenia.
Understanding how tDCS affects brain circuity is critical to the design and application of effective interventions, especially if the effects are different for healthy vs. psychiatric populations. In previous research, one clue to the mechanism underlying increased learning and generalization with tDCS was provided by neuroimaging data from subjects with schizophrenia undergoing cognitive training where increases in thalamocortical (prefrontal) functional connectivity (FC) predicted greater generalization.
The premise of this proposal is that increases in thalamocortical FC are associated with the generalization of cognitive training, and tDCS facilitates these increases. The overarching goals of this proposal are to deploy neuroimaging and cognitive testing to understand how tDCS with cognitive training affect thalamocortical circuitry in individuals with and without psychosis and to examine variability in response within both groups.
Study 1(NCT03896425) will compare right prefrontal, left prefrontal and sham tDCS during concurrent cognitive training over 12 weeks in 90 healthy controls. Study 2 will be similar in all aspects but will examine 90 patients with schizophrenia or schizoaffective disorder and include clinical assessments. Results of the study will provide crucial information about location of stimulation, length of treatment, modeled dosage, trajectory and durability needed to guide future research and interventions for cognitive impairments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| right active-tDCS | Experimental | Device: Transcranial Direct Current Stimulation (tDCS)2-3 times/week for 12 weeks: ramp-up for 30 seconds, 2mA right (AF4 anode - AF3 cathode) for 20 min, and then ramp-down for 30 seconds. |
| left active-tDCS | Experimental | Device: Transcranial Direct Current Stimulation (tDCS)2-3 times/week for 12 weeks: ramp-up for 30 seconds, 2mA left (AF3 anode - AF4 cathode) for 20 min, and then ramp-down for 30 seconds. |
| sham tDCS | Sham comparator | Device: Transcranial Direct Current Stimulation (tDCS)Current will be turned off immediately after the initial 30-second ramp-up period. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Ability to provide consent and comply with study procedures.
- Age 18 - 60 years old.
- Estimated IQ range within the range: 70 ≤ IQ ≤ 115.
- Schizophrenia or schizoaffective disorder as assessed by the MINI (Mini International Neuropsychiatric Interview)(Sheehan et al., 1998).
- Not having a current addictive disorder as measured by MINI (Mini International Neuropsychiatric Interview), or a sleep disorder.
Key exclusion criteria (2 listed)
- Any medical condition or treatment with neurological sequelae (e.g. stroke, tumor, loss of consciousness > 30 min, HIV).
- Contraindications for tDCS or MRI scanning (tDCS contraindication: history of seizures; MRI contraindications: The research team will utilize the CMRR Center's screening tools and adhere to the screening SOP during enrollment of all research participants in this protocol. The CMRR Center's screening tools and SOP are IRB approved under the CMRR Center Grant (HSC# 1406M51205) and information regarding screening procedures is publicly available on the CMRR website (CMRR Policies / Procedures).
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 |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)Three different stimulation montages will be programmed: right, left and sham. During the Ramp periods, 2 mA current will be delivered to both AF3 and AF4 with an ascending (RampUp) and descending ramp (RampDown) over 30 sec via two saline soaked electrode sponges (~ 25cm²; current density = 0.08 mA/cm²). In this way, all subjects experience the same sensation on both sides to blind them to condition. During the Constant period, current will be set based on the Condition: Right - 2mA AF4 anode-AF3 cathode; Left - 2mA applied to AF3 anode-AF4 cathode; Sham - current turned off. | Device | left active-tDCS, right active-tDCS, sham tDCS |
Primary outcome
Changes in Thalamocortical Functional Connectivity (FC)
Time frame: baseline
Most participants completed MRI sessions on a 3T scanner located in the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota. FC measures how different brain regions change in activation together. We characterized FC using global connectivity from graph theory analysis. We extracted the fMRI time courses from 454 parcellations defined by the 400 S4 Schaefer Atlas (Schaefer et al., 2018) combined with the Melbourne Subcortex Atlas (Tian et al., 2020). We computed the absolute value of the Pearson's correlation for all possible pairs of time series, creating a 454x454 (N x N) connectivity matrix, which was then reduced to 10% most significant connections by subject. We estimated the FC by calculating the node strength for each parcellation, which is the weighted mean of all significant connections, from these connectivity matrices. Finally, we averaged node strength across parcellations to calculate global node strength. Higher values indicate more brain-wide FC.
Changes in Task-dependent Thalamocortical Functional Connectivity (fMRI) During the N-back Task.
Time frame: baseline
Task-dependent thalamocortical connectivity associated with the N-back task was calculated by modeling the block task design together with the thalamic regressor using psychophysiological interaction analysis (PPI). The thalamic regressor is the time series of the mediodorsal thalamus from the Melbourne atlas. The primary analysis focused on the 2-back conditions alone. The PPI analysis calculates the functional connectivity between the mediodorsal thalamus and all other brain regions specifically during 2-back trials. Neural activation related to the thalamic regressor was compared to neural activation during the fixation (no choices made) to normalize the relative activation (z-score). Positive values indicate increased functional connectivity with the thalamus during the 2-back choices. A z-score of zero represents no difference compared to the fixation cross (no choices). We report the average z-score of the PPI regressor within the control network (Yeo et al., 2011).
Changes in Task-dependent Thalamocortical Functional Connectivity (fMRI) During the DPX Task.
Time frame: baseline
Task-dependent thalamocortical connectivity associated with the Dot Pattern Expectancy (DPX) task demands will be identified by analyzing cue and probe events together with the thalamic regressor using psychophysiological interaction analysis (PPI). The thalamic regressor is the time series of the mediodorsal thalamus from the Melbourne atlas. We examined B-cue related connectivity. The PPI analysis calculates the functional connectivity between the mediodorsal thalamus and all other brain regions specifically during B-cue trials. Neural activation related to the thalamic regressor was compared to neural activation during the fixation (no choices made) to normalize the relative activation (z-score). Positive values indicate increased functional connectivity with the thalamus during the B-cue responses. A z-score of zero represents no difference compared to the fixation cross (no choices). We report the average z-score of the PPI regressor within the control network.
Change in N-back Performance
Time frame: baseline
The n-back task measures working memory capacity. The participant is presented with a series of stimuli and instructed to indicate with a button press when the current stimulus matches the stimulus that appeared a pre-determined number (n) of trials before. d' (d prime) will be calculated as a measure of signal detection, which indicates the normalized rate of hits to false positives (d' = z(H) - z(F)). Increase in d' signifies improved signal detection, i.e. a better outcome. A d' near zero indicates a performance at chance, i.e., a poor performance. The range is -4.65 to 4.65
Change in DPX Performance
Time frame: baseline
The Dot Pattern Expectancy (DPX) task is an adaptation of the expectancy AX task that uses pairs of simple dot patterns rather than letter pairs as stimuli. The DPX task will be performed in 3 blocks. Each trial consists of a cue dot pattern followed by a probe dot pattern. Different combinations of cues and probes enable the identification of a specific deficit in a subject's ability to maintain goal-relevant information throughout a trial. Timing will be jittered and each block of the DPX task will consist of 40 trials: 24 AX (60%), 6 AY (15%), 6 BX (15%) and 4 BY (10%). Each block will last 6 minutes. d'-context will be calculated as a measure of signal detection, which indicates the normalized rate of AX hits to BX false positives (d' = z(H) - z(F)). Increase in d' -context signified improved signal detection, i.e. a better outcome. A d' near zero indicates a performance at chance, i.e., a poor performance. The range is -4.65 to 4.65.
Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite Score
Time frame: baseline
Intends to provide a relatively brief evaluation of key cognitive domains relevant to schizophrenia and related disorders. The composite score is reported as a T-score, with a mean of 50 and standard deviation of 10. Higher values indicate greater cognitive functioning.
Changes in Thalamocortical Functional Connectivity (FC)
Time frame: mid-test (week 6)
Most participants completed MRI sessions on a 3T scanner located in the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota. FC measures how different brain regions change in activation together. We characterized FC using global connectivity from graph theory analysis. We extracted the fMRI time courses from 454 parcellations defined by the 400 S4 Schaefer Atlas (Schaefer et al., 2018) combined with the Melbourne Subcortex Atlas (Tian et al., 2020). We computed the absolute value of the Pearson's correlation for all possible pairs of time series, creating a 454x454 (N x N) connectivity matrix, which was then reduced to 10% most significant connections by subject. We estimated the FC by calculating the node strength for each parcellation, which is the weighted mean of all significant connections, from these connectivity matrices. Finally, we averaged node strength across parcellations to calculate global node strength. Higher values indicate more brain-wide FC.
Changes in Thalamocortical Functional Connectivity (FC)
Time frame: post-test (week 12)
Most participants completed MRI sessions on a 3T scanner located in the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota. FC measures how different brain regions change in activation together. We characterized FC using global connectivity from graph theory analysis. We extracted the fMRI time courses from 454 parcellations defined by the 400 S4 Schaefer Atlas (Schaefer et al., 2018) combined with the Melbourne Subcortex Atlas (Tian et al., 2020). We computed the absolute value of the Pearson's correlation for all possible pairs of time series, creating a 454x454 (N x N) connectivity matrix, which was then reduced to 10% most significant connections by subject. We estimated the FC by calculating the node strength for each parcellation, which is the weighted mean of all significant connections, from these connectivity matrices. Finally, we averaged node strength across parcellations to calculate global node strength. Higher values indicate more brain-wide FC.
Changes in Task-dependent Thalamocortical Functional Connectivity (fMRI) During the N-back Task.
Time frame: mid-test (week 6)
Task-dependent thalamocortical connectivity associated with the N-back task was calculated by modeling the block task design together with the thalamic regressor using psychophysiological interaction analysis (PPI). The thalamic regressor is the time series of the mediodorsal thalamus from the Melbourne atlas. The primary analysis focused on the 2-back conditions alone. The PPI analysis calculates the functional connectivity between the mediodorsal thalamus and all other brain regions specifically during 2-back trials. Neural activation related to the thalamic regressor was compared to neural activation during the fixation (no choices made) to normalize the relative activation (z-score). Positive values indicate increased functional connectivity with the thalamus during the 2-back choices. A z-score of zero represents no difference compared to the fixation cross (no choices). We report the average z-score of the PPI regressor within the control network (Yeo et al., 2011).
Changes in Task-dependent Thalamocortical Functional Connectivity (fMRI) During the N-back Task.
Time frame: post-test (week 12)
Task-dependent thalamocortical connectivity associated with the N-back task was calculated by modeling the block task design together with the thalamic regressor using psychophysiological interaction analysis (PPI). The thalamic regressor is the time series of the mediodorsal thalamus from the Melbourne atlas. The primary analysis focused on the 2-back conditions alone. The PPI analysis calculates the functional connectivity between the mediodorsal thalamus and all other brain regions specifically during 2-back trials. Neural activation related to the thalamic regressor was compared to neural activation during the fixation (no choices made) to normalize the relative activation (z-score). Positive values indicate increased functional connectivity with the thalamus during the 2-back choices. A z-score of zero represents no difference compared to the fixation cross (no choices). We report the average z-score of the PPI regressor within the control network (Yeo et al., 2011).
Changes in Task-dependent Thalamocortical Functional Connectivity (fMRI) During the DPX Task.
Time frame: mid-test (week 6)
PPI regressor (z-score) within Control Network associated with B-cue Task-dependent thalamocortical connectivity associated with the DPX task demands will be identified by analyzing cue and probe events together with the thalamic regressor using psychophysiological interaction analysis (PPI). The thalamic regressor is the time series of the mediodorsal thalmus from the Melbourne atlas (THA-DAm; Tian et al., 2020). Preliminary analysis for the DPX task will examine B-cue related connectivity alone. We report the average z-score of the PPI regressor within the control network (Yeo et al., 2011). Neural activation was normed to calculated z-scores, such that postive values indicate increased connectivity with the thalamus, and negative values indicate decreased connectivity with the thalamus.
Changes in Task-dependent Thalamocortical Functional Connectivity (fMRI) During the DPX Task.
Time frame: post-test (week 12)
PPI regressor (z-score) within Control Network associated with B-cue Task-dependent thalamocortical connectivity associated with the DPX task demands will be identified by analyzing cue and probe events together with the thalamic regressor using psychophysiological interaction analysis (PPI). The thalamic regressor is the time series of the mediodorsal thalmus from the Melbourne atlas (THA-DAm; Tian et al., 2020). Preliminary analysis for the DPX task will examine B-cue related connectivity alone. We report the average z-score of the PPI regressor within the control network (Yeo et al., 2011). Neural activation was normed to calculated z-scores, such that postive values indicate increased connectivity with the thalamus, and negative values indicate decreased connectivity with the thalamus.
Change in N-back Performance
Time frame: mid-test (week 6)
The n-back task measures working memory capacity. The participant is presented with a series of stimuli and instructed to indicate with a button press when the current stimulus matches the stimulus that appeared a pre-determined number (n) of trials before. d' (d prime) will be calculated as a measure of signal detection, which indicates the normalized rate of hits to false positives (d' = z(H) - z(F)). Increase in d' signifies improved signal detection, i.e. a better outcome. A d' near zero indicates a performance at chance, i.e., a poor performance. The range is -4.65 to 4.65
Change in N-back Performance
Time frame: post-test (week 12)
The n-back task measures working memory capacity. The participant is presented with a series of stimuli and instructed to indicate with a button press when the current stimulus matches the stimulus that appeared a pre-determined number (n) of trials before. d' (d prime) will be calculated as a measure of signal detection, which indicates the normalized rate of hits to false positives (d' = z(H) - z(F)). Increase in d' signifies improved signal detection, i.e. a better outcome. A d' near zero indicates a performance at chance, i.e., a poor performance. The range is -4.65 to 4.65
Change in DPX Performance
Time frame: mid-test (week 6)
The Dot Pattern Expectancy (DPX) task is an adaptation of the expectancy AX task that uses pairs of simple dot patterns rather than letter pairs as stimuli. The DPX task will be performed in 3 blocks. Each trial consists of a cue dot pattern followed by a probe dot pattern. Different combinations of cues and probes enable the identification of a specific deficit in a subject's ability to maintain goal-relevant information throughout a trial. Timing will be jittered and each block of the DPX task will consist of 40 trials: 24 AX (60%), 6 AY (15%), 6 BX (15%) and 4 BY (10%). Each block will last 6 minutes. d'-context will be calculated as a measure of signal detection, which indicates the normalized rate of AX hits to BX false positives (d' = z(H) - z(F)). Increase in d' -context signified improved signal detection, i.e. a better outcome. A d' near zero indicates a performance at chance, i.e., a poor performance. The range is -4.65 to 4.65.
Change in DPX Performance
Time frame: post-test (week 12)
The Dot Pattern Expectancy (DPX) task is an adaptation of the expectancy AX task that uses pairs of simple dot patterns rather than letter pairs as stimuli. The DPX task will be performed in 3 blocks. Each trial consists of a cue dot pattern followed by a probe dot pattern. Different combinations of cues and probes enable the identification of a specific deficit in a subject's ability to maintain goal-relevant information throughout a trial. Timing will be jittered and each block of the DPX task will consist of 40 trials: 24 AX (60%), 6 AY (15%), 6 BX (15%) and 4 BY (10%). Each block will last 6 minutes. d'-context will be calculated as a measure of signal detection, which indicates the normalized rate of AX hits to BX false positives (d' = z(H) - z(F)). Increase in d' -context signified improved signal detection, i.e. a better outcome. A d' near zero indicates a performance at chance, i.e., a poor performance. The range is -4.65 to 4.65.
Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite Score
Time frame: mid-test (week 6)
MCCB Composite T-Score Intends to provide a relatively brief evaluation of key cognitive domains relevant to schizophrenia and related disorders. The composite score is reported as a T-score, with a mean of 50 and standard deviation of 10. Higher values indicate greater cognitive functioning.
Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite Score
Time frame: post-test (week 12)
MCCB Composite T-Score Intends to provide a relatively brief evaluation of key cognitive domains relevant to schizophrenia and related disorders. The composite score is reported as a T-score, with a mean of 50 and standard deviation of 10. Higher values indicate greater cognitive functioning.
Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite Score
Time frame: follow-up (week 24)
MCCB Composite T-Score Intends to provide a relatively brief evaluation of key cognitive domains relevant to schizophrenia and related disorders. The composite score is reported as a T-score, with a mean of 50 and standard deviation of 10. Higher values indicate greater cognitive functioning.
12 secondary outcomes
Change in University of California San Diego Performance-Based Skills Assessment - Brief (UPSA-B)
Time frame: baseline
Change in Brief Psychiatric Rating Scale (BPRS) Score
Time frame: baseline
Change in Brief Negative Symptom Scale (BNSS) Score
Time frame: baseline
Change in University of California San Diego Performance-Based Skills Assessment - Brief (UPSA-B)
Time frame: mid-test (week 6)
Change in University of California San Diego Performance-Based Skills Assessment - Brief (UPSA-B)
Time frame: post-test (week 12)
Change in University of California San Diego Performance-Based Skills Assessment - Brief (UPSA-B)
Time frame: follow-up (week 24)
Change in Brief Psychiatric Rating Scale (BPRS) Score
Time frame: mid-test (week 6)
Change in Brief Psychiatric Rating Scale (BPRS) Score
Time frame: post-test (week 12)
Change in Brief Psychiatric Rating Scale (BPRS) Score
Time frame: follow-up (week 24)
Change in Brief Negative Symptom Scale (BNSS) Score
Time frame: Mid-test (week 6)
Change in Brief Negative Symptom Scale (BNSS) Score
Time frame: post-test (week 12)
Change in Brief Negative Symptom Scale (BNSS) Score
Time frame: follow-up (week 24)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Transcranial Direct Current Stimulation and Schizophrenia, run by University of Minnesota 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 7 inclusion and 2 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 19 Sep 2024. 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. Some participants in this study may receive a placebo. 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 19 Sep 2024). 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?
Changes in Thalamocortical Functional Connectivity (FC) (time frame: baseline). The study lists 19 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 19 Sep 2024.