SchizophreniaNCT02739347
Non-Invasive Direct Current Stimulation for Cognition in Schizophrenia
A study testing Active Trans-cranial direct-current stimulation in people with Schizophrenia and Psychosis, run by Baylor College of Medicine at 1 site in United States.
Trial summary
This study proposes to assess the effect of trans-cranial direct current stimulation (tDCS) on cognitive control, working memory, functional, clinical, and cognitive outcomes in schizophrenia patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia, Psychosis
- What is being tested?
- Active Trans-cranial direct-current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Jun 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Early course psychosis:
- DSM-V diagnosis of Schizophrenia, Schizoaffective disorder, or schizophreniform disorder.
- ages 18-50 years
- on stable doses of medication for at least one month
- not taking benzodiazepines or mood stabilizers.
- Mild to severe cognitive impairment in MATRICS Consensus Cognitive Battery (composite scores < 40)
- Chronic psychosis:
- Same as early course psychosis but >5 years of antipsychotic treatment
Who cannot join
- Diagnostic and Statistical Manual-Version V (DSM-V) diagnosis of mental retardation
- significant head injury
- medical illness affecting brain function or structure
- pregnancy or postpartum (<6 weeks after delivery or miscarriage)
- significant neurologic disorder (e.g seizure disorder)
- inability to provide informed consent
Show all 11Show fewer
- significant color blindness that affects task performance
- Comorbidity for DSM-V substance abuse disorder within the past one month
- Temporal relation between illness onset and head injury
- Taking benzodiazepines or mood stabilizers (lithium allowed)
- Positive drug screen (excluding THC at baseline)
Trial locations and contacts
1 site in 1 country.
About this study
This study proposes to assess the effect of trans-cranial direct current stimulation (tDCS) on cognitive control, working memory, functional, clinical, and cognitive outcomes in schizophrenia patients.
Read the detailed description
Cognitive functions and EEG correlates will be thoroughly assessed in schizophrenia patients undergoing a tDCS treatment and compared with patients receiving a placebo stimulation. The treatment will involve 20 minutes of tDCS application to the left prefrontal and temporo-parietal cortex, twice a day for five days, a procedure shown to be effective in improving other symptoms of psychosis such as negative symptoms and hallucinations. Critically, in addition to standard neuropsychological testing, cognitive assessments will involve tasks that tap cognitive control and working memory, impairments in which comprise two of the core cognitive disturbances in schizophrenia and which have been linked to brain rhythm disturbances measurable by EEG recordings. Investigators will also assess changes in functional outcome by tDCS and investigate relationships between improvements in cognition, brain rhythms and functional outcome. All these assessments will occur just prior to tDCS application, just after completion of the tDCS series, and then again at 2 months follow-up. There will be two separate independent groups of patients who will be randomized to active versus sham treatments. The first group will have early course schizophrenia (less than 5 years of antipsychotic treatment; n=40). The second group will be chronic schizophrenia (greater than 5 years of antipsychotic treatment; n=40).
Relevance
This proposal would be the first integrated study of the effects of tDCS on cognitive symptoms, brain function and functional outcome in schizophrenia. A positive outcome would represent a marked improvement in clinical therapeutics for cognition in psychosis and provide a powerful tool for improving functional outcome in this debilitating disorder. Understanding the impact on brain rhythm disturbances could support the study of similar stimulation-based therapeutic approaches to other neuropsychiatric disorders that shows similar disturbances in cognition and brain rhythms activity, such as bipolar disorder and autism.
- Conditions
- Schizophrenia, Psychosis
- Being tested
- Active Trans-cranial direct-current stimulation, Sham Trans-cranial direct current stimulation
- Keywords
- tDCS, cognitive control, working memory, EEG, gamma oscillations
- 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.
Active Trans-cranial direct-current stimulationDevice
Also called tDCS
Active stimulation group will receive 20 min of 2 mA direct current stimulation.
Sham Trans-cranial direct current stimulationDevice
Also called tDCS
This will be an active sham involving brief (15 msec) low current (0.11 mA) pulses every 550 ms.
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation | Experimental | Active stimulation group will receive 20 min of 2 mA direct current stimulation. Receives: Device: Active Trans-cranial direct-current stimulation |
| Sham Stimulation | Sham comparator | This will be an active sham involving brief (15 msec) low current (0.11 mA) pulses every 550 ms. Receives: Device: Sham Trans-cranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Control
The investigators will assess cognitive control using the Preparing to Overcome Prepotency (POP) task. The accuracy mean differences between the high and low control conditions will be used as dependent measures.
The study is powered at 0.8 to observe a post-pre treatment improvement in cognitive control with a substantial effect size (d=0.56) compared to sham stimulation with effects relatively stable measured 2 months after baseline. The hypothesized effect size will be d=0.60.
Measured: Week 1
Working Memory
The investigators will assess working memory using a working memory task. The accuracy mean differences between the high and low control conditions will be used as dependent measures.
The study is powered at 0.8 to observe a post-pre treatment improvement in cognitive control with a substantial effect size (d=0.56) compared to sham stimulation with effects relatively stable measured 2 months after baseline. The hypothesized effect size will be d=0.60.
Measured: Week 1
Secondary outcomes (2)
Negative Symptoms
A secondary outcome measure is the severity of negative symptoms as quantified by Scale for the Assessment of Negative Symptoms (SANS). This study is powered at 0.8 to observe a post-pre treatment improvement in negative symptoms with a moderate effect size (d=0.56) compared to sham stimulation with effects relatively stable measured 2 months after baseline. The hypothesized effect size will be d=0.60.
Measured: Week 1
Auditory Hallucinations
A secondary outcome measure is the change over time in the severity of auditory hallucinations as assessed by the Auditory Hallucination Rating Scale (AHRS).
In a study conducted using a similar montage and current strength (Brunelin et. al 2012), a reduction in auditory hallucinations with a substantial effect size (d=1.58) was observed in 30 patients with schizophrenia. However, as their study recruited only those patients with severe hallucinations while the current study does not have such an inclusion criterion. The investigators expect a more modest effect size of d=0.60.
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2019
- Study completionJun 2019
Why it stopped: Unable to recruit successfully
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.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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, Care provider, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Responsible party
- Principal investigator, Raymond Cho, Baylor College of Medicine
- Investigators
- Raymond Cho, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739347
- Sponsor's protocol ID
- H-42322
- Status last verified
- Jun 2022
- First submitted
- 5 Apr 2016
- Last updated
- 7 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be open to sharing after primary findings of study have been published.
Publications
Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091.
PubMed 22581236Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.
PubMed 22037126Cho RY, Konecky RO, Carter CS. Impairments in frontal cortical gamma synchrony and cognitive control in schizophrenia. Proc Natl Acad Sci U S A. 2006 Dec 26;103(52):19878-83. doi: 10.1073/pnas.0609440103. Epub 2006 Dec 14.
PubMed 17170134Green MF. What are the functional consequences of neurocognitive deficits in schizophrenia? Am J Psychiatry. 1996 Mar;153(3):321-30. doi: 10.1176/ajp.153.3.321.
PubMed 8610818Lisman J, Buzsaki G. A neural coding scheme formed by the combined function of gamma and theta oscillations. Schizophr Bull. 2008 Sep;34(5):974-80. doi: 10.1093/schbul/sbn060. Epub 2008 Jun 16.
PubMed 18559405Mondino M, Brunelin J, Palm U, Brunoni AR, Poulet E, Fecteau S. Transcranial Direct Current Stimulation for the Treatment of Refractory Symptoms of Schizophrenia. Current Evidence and Future Directions. Curr Pharm Des. 2015;21(23):3373-83. doi: 10.2174/1381612821666150619093648.
PubMed 26088110Stagg CJ, Best JG, Stephenson MC, O'Shea J, Wylezinska M, Kincses ZT, Morris PG, Matthews PM, Johansen-Berg H. Polarity-sensitive modulation of cortical neurotransmitters by transcranial stimulation. J Neurosci. 2009 Apr 22;29(16):5202-6. doi: 10.1523/JNEUROSCI.4432-08.2009.
PubMed 19386916Stagg CJ, Nitsche MA. Physiological basis of transcranial direct current stimulation. Neuroscientist. 2011 Feb;17(1):37-53. doi: 10.1177/1073858410386614.
PubMed 21343407Uhlhaas PJ, Singer W. Abnormal neural oscillations and synchrony in schizophrenia. Nat Rev Neurosci. 2010 Feb;11(2):100-13. doi: 10.1038/nrn2774.
PubMed 20087360Volk DW, Lewis DA. Prefrontal cortical circuits in schizophrenia. Curr Top Behav Neurosci. 2010;4:485-508. doi: 10.1007/7854_2010_44.
PubMed 21312410
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Direct Current Stimulation for Cognition in Schizophrenia
- ClinicalTrials.gov ID
- NCT02739347
- Acronym / sponsor ID
- H-42322
- Conditions
- Schizophrenia, Psychosis
- Keywords
- tDCS, cognitive control, working memory, EEG, gamma oscillations
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit successfully
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Study start
- May 2016
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Posted 7 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study proposes to assess the effect of trans-cranial direct current stimulation (tDCS) on cognitive control, working memory, functional, clinical, and cognitive outcomes in schizophrenia patients.
Detailed description
Cognitive functions and EEG correlates will be thoroughly assessed in schizophrenia patients undergoing a tDCS treatment and compared with patients receiving a placebo stimulation. The treatment will involve 20 minutes of tDCS application to the left prefrontal and temporo-parietal cortex, twice a day for five days, a procedure shown to be effective in improving other symptoms of psychosis such as negative symptoms and hallucinations. Critically, in addition to standard neuropsychological testing, cognitive assessments will involve tasks that tap cognitive control and working memory, impairments in which comprise two of the core cognitive disturbances in schizophrenia and which have been linked to brain rhythm disturbances measurable by EEG recordings. Investigators will also assess changes in functional outcome by tDCS and investigate relationships between improvements in cognition, brain rhythms and functional outcome. All these assessments will occur just prior to tDCS application, just after completion of the tDCS series, and then again at 2 months follow-up. There will be two separate independent groups of patients who will be randomized to active versus sham treatments. The first group will have early course schizophrenia (less than 5 years of antipsychotic treatment; n=40). The second group will be chronic schizophrenia (greater than 5 years of antipsychotic treatment; n=40).
Relevance
This proposal would be the first integrated study of the effects of tDCS on cognitive symptoms, brain function and functional outcome in schizophrenia. A positive outcome would represent a marked improvement in clinical therapeutics for cognition in psychosis and provide a powerful tool for improving functional outcome in this debilitating disorder. Understanding the impact on brain rhythm disturbances could support the study of similar stimulation-based therapeutic approaches to other neuropsychiatric disorders that shows similar disturbances in cognition and brain rhythms activity, such as bipolar disorder and autism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Experimental | Device: Active Trans-cranial direct-current stimulationActive stimulation group will receive 20 min of 2 mA direct current stimulation. |
| Sham Stimulation | Sham comparator | Device: Sham Trans-cranial direct current stimulationThis will be an active sham involving brief (15 msec) low current (0.11 mA) pulses every 550 ms. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- DSM-V diagnosis of Schizophrenia, Schizoaffective disorder, or schizophreniform disorder.
- ages 18-50 years
- on stable doses of medication for at least one month
- not taking benzodiazepines or mood stabilizers.
- Mild to severe cognitive impairment in MATRICS Consensus Cognitive Battery (composite scores < 40)
Key exclusion criteria (11 listed)
- Diagnostic and Statistical Manual-Version V (DSM-V) diagnosis of mental retardation
- significant head injury
- medical illness affecting brain function or structure
- pregnancy or postpartum (<6 weeks after delivery or miscarriage)
- significant neurologic disorder (e.g seizure disorder)
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 |
|---|---|---|
| Active Trans-cranial direct-current stimulationAlso: tDCSActive stimulation group will receive 20 min of 2 mA direct current stimulation. | Device | Active Stimulation |
| Sham Trans-cranial direct current stimulationAlso: tDCSThis will be an active sham involving brief (15 msec) low current (0.11 mA) pulses every 550 ms. | Device | Sham Stimulation |
Primary outcome
Cognitive Control
Time frame: Week 1
The investigators will assess cognitive control using the Preparing to Overcome Prepotency (POP) task. The accuracy mean differences between the high and low control conditions will be used as dependent measures. The study is powered at 0.8 to observe a post-pre treatment improvement in cognitive control with a substantial effect size (d=0.56) compared to sham stimulation with effects relatively stable measured 2 months after baseline. The hypothesized effect size will be d=0.60.
Working Memory
Time frame: Week 1
The investigators will assess working memory using a working memory task. The accuracy mean differences between the high and low control conditions will be used as dependent measures. The study is powered at 0.8 to observe a post-pre treatment improvement in cognitive control with a substantial effect size (d=0.56) compared to sham stimulation with effects relatively stable measured 2 months after baseline. The hypothesized effect size will be d=0.60.
2 secondary outcomes
Negative Symptoms
Time frame: Week 1
Auditory Hallucinations
Time frame: Week 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22581236Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091.
- Background: PubMed 22037126Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.
- Background: PubMed 17170134Cho RY, Konecky RO, Carter CS. Impairments in frontal cortical gamma synchrony and cognitive control in schizophrenia. Proc Natl Acad Sci U S A. 2006 Dec 26;103(52):19878-83. doi: 10.1073/pnas.0609440103. Epub 2006 Dec 14.
- Background: PubMed 8610818Green MF. What are the functional consequences of neurocognitive deficits in schizophrenia? Am J Psychiatry. 1996 Mar;153(3):321-30. doi: 10.1176/ajp.153.3.321.
- Background: PubMed 18559405Lisman J, Buzsaki G. A neural coding scheme formed by the combined function of gamma and theta oscillations. Schizophr Bull. 2008 Sep;34(5):974-80. doi: 10.1093/schbul/sbn060. Epub 2008 Jun 16.
- Background: PubMed 26088110Mondino M, Brunelin J, Palm U, Brunoni AR, Poulet E, Fecteau S. Transcranial Direct Current Stimulation for the Treatment of Refractory Symptoms of Schizophrenia. Current Evidence and Future Directions. Curr Pharm Des. 2015;21(23):3373-83. doi: 10.2174/1381612821666150619093648.
- Background: PubMed 19386916Stagg CJ, Best JG, Stephenson MC, O'Shea J, Wylezinska M, Kincses ZT, Morris PG, Matthews PM, Johansen-Berg H. Polarity-sensitive modulation of cortical neurotransmitters by transcranial stimulation. J Neurosci. 2009 Apr 22;29(16):5202-6. doi: 10.1523/JNEUROSCI.4432-08.2009.
- Background: PubMed 21343407Stagg CJ, Nitsche MA. Physiological basis of transcranial direct current stimulation. Neuroscientist. 2011 Feb;17(1):37-53. doi: 10.1177/1073858410386614.
- Background: PubMed 20087360Uhlhaas PJ, Singer W. Abnormal neural oscillations and synchrony in schizophrenia. Nat Rev Neurosci. 2010 Feb;11(2):100-13. doi: 10.1038/nrn2774.
- Background: PubMed 21312410Volk DW, Lewis DA. Prefrontal cortical circuits in schizophrenia. Curr Top Behav Neurosci. 2010;4:485-508. doi: 10.1007/7854_2010_44.
- Individual participant dataSharing planned: Yes. Data will be open to sharing after primary findings of study have been published.
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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.
Raymond Cho, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Trans-cranial direct-current stimulation in people with Schizophrenia and Psychosis, run by Baylor College of Medicine 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 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jul 2022. 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 7 Jul 2022). 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?
Cognitive Control (time frame: Week 1). 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?
On the ClinicalTrials.gov record for NCT02739347, which also lists 10 linked publications.
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 7 Jul 2022.