SchizophreniaNCT03370341
Stimulating the Brain to Improve Self-Awareness
A study testing active anodal tDCS in people with Schizophrenia and Schizoaffective Disorder, run by The University of Texas at Dallas at 1 site in United States.
Trial summary
This study investigates whether Introspective Accuracy (IA) can be improved in individuals with schizophrenia by stimulating the brain via transcranial Direct Current Stimulation (tDCS). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- active anodal tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-55
- DSM-IV-TR or DSM-5 diagnosis of schizophrenia or schizoaffective disorder and clinically stable (i.e., no hospitalizations) for at least 8 weeks and on a stable medication regimen for at least 6 weeks with no dose changes for a minimum of 2 weeks
Who cannot join
- Presence or history of pervasive developmental disorder (e.g., autism) or mental retardation (defined as IQ <70) by DSM-IV criteria
- Presence or history of medical, cardiac, or neurological disorders that may affect brain function (e.g., cardiac disease, endocrine disorders, renal disease, pulmonary disease, history of seizures or head trauma with unconsciousness for a period of 15 minutes or greater or CNS tumors)
- Presence of sensory limitation including visual (e.g., blindness, glaucoma, vision uncorrectable to 20/40) or hearing (e.g. hearing loss) impairments that interfere with assessment
- Not proficient in English
- Presence of substance abuse in the past one month
- Presence of substance dependence not in remission for the past six months
- Contraindications for tDCS (e.g., pregnancy or implanted devices such as pace maker)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Unversity of Texas at Dallas
Richardson, Texas, 75080
About this study
This study investigates whether Introspective Accuracy (IA) can be improved in individuals with schizophrenia by stimulating the brain via transcranial Direct Current Stimulation (tDCS).
Read the detailed description
Self-awareness is markedly impaired in severe mental illness including schizophrenia and schizoaffective disorder. This impairment spans awareness of symptoms as well as deficits in the estimation of abilities and capabilities, which we refer to as introspective accuracy (IA). Recent work has provided evidence of IA deficits in schizophrenia spectrum disorders, specifically in the abilities to retrospectively judge everyday functioning and neurocognitive impairment, as well as the ability to make correct real-time judgments of performance on neurocognitive tests.
Transcranial Direct Current Stimulation (tDCS) is a form of noninvasive neurostimulation which has been proposed as a therapeutic procedure in numerous psychiatric disorders. TDCS in healthy adults has been demonstrated to improve cognitive and memory performance, and in schizophrenia, tDCS has been found to improve emotion recognition ability. TDCS thus appears to be a promising therapeutic technique that may be useful for improving IA. This study will compare IA performance in individuals with schizophrenia across two conditions: active anodal tDCS and sham tDCS.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- active anodal tDCS, sham tDCS
- 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 anodal tDCSDevice
active anodal tDCS with behavioral tasks to assess IA
sham tDCSDevice
sham tDCS with behavioral tasks to assess IA
| Study group | Role | What they receive |
|---|---|---|
| Active anodal tDCS first, then Sham tDCS | Experimental | Active anodal tDCS (20 minutes) followed by behavioral testing; Washout (1 week); sham stimulation (20 minutes) followed by behavioral testing Intervention: Device: active anodal tDCS and sham tDCS Receives: Device: active anodal tDCS; Device: sham tDCS |
| Sham tDCS first, then Active anodal tDCS | Sham comparator | Sham tDCS (20 minutes) followed by behavioral testing; Washout (1 week); Active anodal tDCS (20 minutes) followed by behavioral testing Intervention: Device: sham tDCS and sham tDCS Receives: Device: active anodal tDCS; Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive Introspective Accuracy for Active vs. Sham Stimulation
Neurocognitive Introspective Accuracy (IA) was assessed with the Wisconsin Card Sorting Task after both Active and Sham stimulation. The area under a type 2 ROC (receiver operating characteristic) curve was used to index IA. Values range from .5-1, with higher values indicating better IA.
Measured: Assessment will be completed 30 minutes after completion of the active/sham stimulation
Secondary outcomes (1)
Social Cognitive Introspective Accuracy for Active vs. Sham Stimulation
Social Cognitive Introspective Accuracy assessed with the Penn Emotion Recognition Task (ER40) after both Active and Sham stimulation. The area under a type 2 ROC (receiver operating characteristic) curve was used to index IA. Values range from .5-1, with higher values indicating better IA.
Measured: Assessment will be completed 30 minutes after completion of the active/sham stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start1 Dec 2017
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will complete active and sham simulation sessions in a randomized, counterbalanced order approximately one week apart.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Pinkham, PhD, The University of Texas at Dallas
- Investigators
- Amy Pinkham, PhD, Principal investigator, The University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370341
- Sponsor's protocol ID
- 17-127
- Status last verified
- Mar 2023
- First submitted
- 7 Dec 2017
- Last updated
- 22 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulating the Brain to Improve Self-Awareness
- ClinicalTrials.gov ID
- NCT03370341
- Acronym / sponsor ID
- 17-127
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Posted 3 Aug 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 investigates whether Introspective Accuracy (IA) can be improved in individuals with schizophrenia by stimulating the brain via transcranial Direct Current Stimulation (tDCS).
Detailed description
Self-awareness is markedly impaired in severe mental illness including schizophrenia and schizoaffective disorder. This impairment spans awareness of symptoms as well as deficits in the estimation of abilities and capabilities, which we refer to as introspective accuracy (IA). Recent work has provided evidence of IA deficits in schizophrenia spectrum disorders, specifically in the abilities to retrospectively judge everyday functioning and neurocognitive impairment, as well as the ability to make correct real-time judgments of performance on neurocognitive tests.
Transcranial Direct Current Stimulation (tDCS) is a form of noninvasive neurostimulation which has been proposed as a therapeutic procedure in numerous psychiatric disorders. TDCS in healthy adults has been demonstrated to improve cognitive and memory performance, and in schizophrenia, tDCS has been found to improve emotion recognition ability. TDCS thus appears to be a promising therapeutic technique that may be useful for improving IA. This study will compare IA performance in individuals with schizophrenia across two conditions: active anodal tDCS and sham tDCS.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will complete active and sham simulation sessions in a randomized, counterbalanced order approximately one week apart.
| Arm | Type | Receives |
|---|---|---|
| Active anodal tDCS first, then Sham tDCS | Experimental | Device: active anodal tDCS, Device: sham tDCSActive anodal tDCS (20 minutes) followed by behavioral testing; Washout (1 week); sham stimulation (20 minutes) followed by behavioral testing Intervention: Device: active anodal tDCS and sham tDCS |
| Sham tDCS first, then Active anodal tDCS | Sham comparator | Device: active anodal tDCS, Device: sham tDCSSham tDCS (20 minutes) followed by behavioral testing; Washout (1 week); Active anodal tDCS (20 minutes) followed by behavioral testing Intervention: Device: sham tDCS and sham tDCS |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 18-55
- DSM-IV-TR or DSM-5 diagnosis of schizophrenia or schizoaffective disorder and clinically stable (i.e., no hospitalizations) for at least 8 weeks and on a stable medication regimen for at least 6 weeks with no dose changes for a minimum of 2 weeks
Key exclusion criteria (7 listed)
- Presence or history of pervasive developmental disorder (e.g., autism) or mental retardation (defined as IQ <70) by DSM-IV criteria
- Presence or history of medical, cardiac, or neurological disorders that may affect brain function (e.g., cardiac disease, endocrine disorders, renal disease, pulmonary disease, history of seizures or head trauma with unconsciousness for a period of 15 minutes or greater or CNS tumors)
- Presence of sensory limitation including visual (e.g., blindness, glaucoma, vision uncorrectable to 20/40) or hearing (e.g. hearing loss) impairments that interfere with assessment
- Not proficient in English
- Presence of substance abuse in the past one month
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 anodal tDCSactive anodal tDCS with behavioral tasks to assess IA | Device | Active anodal tDCS first, then Sham tDCS, Sham tDCS first, then Active anodal tDCS |
| sham tDCSsham tDCS with behavioral tasks to assess IA | Device | Active anodal tDCS first, then Sham tDCS, Sham tDCS first, then Active anodal tDCS |
Primary outcome
Neurocognitive Introspective Accuracy for Active vs. Sham Stimulation
Time frame: Assessment will be completed 30 minutes after completion of the active/sham stimulation
Neurocognitive Introspective Accuracy (IA) was assessed with the Wisconsin Card Sorting Task after both Active and Sham stimulation. The area under a type 2 ROC (receiver operating characteristic) curve was used to index IA. Values range from .5-1, with higher values indicating better IA.
1 secondary outcome
Social Cognitive Introspective Accuracy for Active vs. Sham Stimulation
Time frame: Assessment will be completed 30 minutes after completion of the active/sham stimulation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Pinkham, PhD principal investigator
The University of Texas at Dallas
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 anodal tDCS in people with Schizophrenia and Schizoaffective Disorder, run by The University of Texas at Dallas 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 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. 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 3 Aug 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?
Neurocognitive Introspective Accuracy for Active vs. Sham Stimulation (time frame: Assessment will be completed 30 minutes after completion of the active/sham stimulation). 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 22 Mar 2023.