SchizophreniaNCT02869334
Remediation of Auditory Recognition in Schizophrenia With tDCS
A study testing Active Transcranial direct current stimulation (tDCS) and Auditory Remediation in people with Schizophrenia and Schizoaffective Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine whether transcranial direct current stimulation (tDCS), when combined with different forms of computer based training, improves the ability to discriminate small differences between sounds in people diagnosed with schizophrenia or schizoaffective disorder. 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 Transcranial direct current stimulation (tDCS) and Auditory Remediation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 31 Jan 2020
- 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
- Primary diagnosis of Schizophrenia or schizoaffective disorder
- English fluency
- Willing/capable to provide informed consent
- Auditory tone matching deficits
- Receiving stable doses of antipsychotic medication(s) for at least 2 weeks
- IQ>75
Who cannot join
- Serious neurological disorder or medical condition/ treatment known to affect the brain. Neurological Disorder that affects the central nervous system (CNS), such as epilepsy, neurodegenerative disorders, movement disorders and sensory disorders.
- Current or past history (within the last 6 months) of substance abuse or dependence (excluding nicotine)
- Pregnancy or breastfeeding
- Taking anticholinergic medication (e.g. Cogentin, Thorazine, Clozaril, thioridazine)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Remediation of Auditory Recognition in Schizophrenia With Transcranial Direct Current Stimulation (tDCS)
The purpose of this study is to determine whether transcranial direct current stimulation (tDCS), when combined with different forms of computer based training, improves the ability to discriminate small differences between sounds in people diagnosed with schizophrenia or schizoaffective disorder.
Read the detailed description
This study uses an experimental procedure called transcranial direct current stimulation (tDCS). Little is known about how tDCS affects the brain or why some people diagnosed with schizophrenia or schizoaffective disorder have trouble with certain kinds of hearing. This study is being done to see if an experimental computer training program, when combined with tDCS, can help people to hear better. In tDCS, a small amount of electricity is passed through electrodes placed on the head that is able to stimulate the brain. By stimulating the brain, the investigators believe that the functioning of the brain can be altered. This study will test whether such stimulation of the brain, when done with computer training, can improve hearing ability and if this improvement helps in other ways, like detecting changes in someone's tone of voice or understanding other people's emotions better. The data being collected aims to better understand how the brain processes sounds and how tDCS affects the brain.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Active Transcranial direct current stimulation (tDCS), Sham Transcranial direct current stimulation (tDCS), Auditory Remediation, Control computer activities
- 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 Transcranial direct current stimulation (tDCS)Device
Active tDCS, where an extremely weak electric current passes through the brain
Sham Transcranial direct current stimulation (tDCS)Device
Sham (inactive or placebo) tDCS
Auditory RemediationBehavioural
Computer program designed to improve discrimination between sounds
Control computer activitiesBehavioural
Computer program (e.g. games), which are not designed to improve discrimination between sounds
| Study group | Role | What they receive |
|---|---|---|
| Auditory remediation with active tDCS | Experimental | Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Receives: Device: Active Transcranial direct current stimulation (tDCS); Behavioral: Auditory Remediation |
| Auditory remediation with sham tDCS | Experimental | Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Receives: Device: Sham Transcranial direct current stimulation (tDCS); Behavioral: Auditory Remediation |
| Control (computer games with sham tDCS) | Sham comparator | Non-remediation, control computer activities (e.g. games) with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Receives: Device: Sham Transcranial direct current stimulation (tDCS); Behavioral: Control computer activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Auditory Tone Matching Task
Ability to match tones following brief delay
Measured: Change in performance from Baseline at completion of training (week 16)
Secondary outcomes (4)
Auditory Emotion Recognition (AER) Task
Ability to detect emotion based on tone of voice
Measured: Change in performance from Baseline at completion of training (week 16)
ER-40
Penn Emotion Recognition Test-40 Faces Version
Measured: Change in performance from Baseline at completion of training (week 16)
The Awareness of Social Inference Test (TASIT)
The TASIT is a measure of social cognition, theory of mind as reflected in the ability to detect lies/sarcasm while viewing social vignettes. Total scores range from 0-100% correct. Higher numbers (positive change) are considered better.
Measured: Change in performance from Baseline at completion of training (week 16)
Auditory Mismatch Negativity (MMN)
Change in event related potentials (ERP) acquired during a task of auditory mismatch negativity (MMN), assessed with electroencephalography (EEG)
Measured: Change in performance from Baseline at completion of training (week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startJun 2016
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
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 (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Nathan Kline Institute for Psychiatric Research
- Responsible party
- Principal investigator, Daniel C. Javitt, New York State Psychiatric Institute
- Investigators
- Daniel Javitt, MD, PhD, Principal investigator, NY State Psychiatric Institute, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869334
- Sponsor's protocol ID
- 7266
- Status last verified
- Jun 2021
- First submitted
- 19 Jul 2016
- Last updated
- 8 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.
PubMed 33539561
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remediation of Auditory Recognition in Schizophrenia With Transcranial Direct Current Stimulation (tDCS)
- ClinicalTrials.gov ID
- NCT02869334
- Acronym / sponsor ID
- 7266
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Nathan Kline Institute for Psychiatric Research
- Study start
- Jun 2016 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Posted 8 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether transcranial direct current stimulation (tDCS), when combined with different forms of computer based training, improves the ability to discriminate small differences between sounds in people diagnosed with schizophrenia or schizoaffective disorder.
Detailed description
This study uses an experimental procedure called transcranial direct current stimulation (tDCS). Little is known about how tDCS affects the brain or why some people diagnosed with schizophrenia or schizoaffective disorder have trouble with certain kinds of hearing. This study is being done to see if an experimental computer training program, when combined with tDCS, can help people to hear better. In tDCS, a small amount of electricity is passed through electrodes placed on the head that is able to stimulate the brain. By stimulating the brain, the investigators believe that the functioning of the brain can be altered. This study will test whether such stimulation of the brain, when done with computer training, can improve hearing ability and if this improvement helps in other ways, like detecting changes in someone's tone of voice or understanding other people's emotions better. The data being collected aims to better understand how the brain processes sounds and how tDCS affects the brain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Auditory remediation with active tDCS | Experimental | Device: Active Transcranial direct current stimulation (tDCS), Behavioral: Auditory RemediationAuditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week |
| Auditory remediation with sham tDCS | Experimental | Device: Sham Transcranial direct current stimulation (tDCS), Behavioral: Auditory RemediationAuditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week |
| Control (computer games with sham tDCS) | Sham comparator | Device: Sham Transcranial direct current stimulation (tDCS), Behavioral: Control computer activitiesNon-remediation, control computer activities (e.g. games) with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-55
- Primary diagnosis of Schizophrenia or schizoaffective disorder
- English fluency
- Willing/capable to provide informed consent
- Auditory tone matching deficits
Key exclusion criteria (4 listed)
- Serious neurological disorder or medical condition/ treatment known to affect the brain. Neurological Disorder that affects the central nervous system (CNS), such as epilepsy, neurodegenerative disorders, movement disorders and sensory disorders.
- Current or past history (within the last 6 months) of substance abuse or dependence (excluding nicotine)
- Pregnancy or breastfeeding
- Taking anticholinergic medication (e.g. Cogentin, Thorazine, Clozaril, thioridazine)
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 Transcranial direct current stimulation (tDCS)Active tDCS, where an extremely weak electric current passes through the brain | Device | Auditory remediation with active tDCS |
| Sham Transcranial direct current stimulation (tDCS)Sham (inactive or placebo) tDCS | Device | Auditory remediation with sham tDCS, Control (computer games with sham tDCS) |
| Auditory RemediationComputer program designed to improve discrimination between sounds | Behavioural | Auditory remediation with active tDCS, Auditory remediation with sham tDCS |
| Control computer activitiesComputer program (e.g. games), which are not designed to improve discrimination between sounds | Behavioural | Control (computer games with sham tDCS) |
Primary outcome
Auditory Tone Matching Task
Time frame: Change in performance from Baseline at completion of training (week 16)
Ability to match tones following brief delay
4 secondary outcomes
Auditory Emotion Recognition (AER) Task
Time frame: Change in performance from Baseline at completion of training (week 16)
ER-40
Time frame: Change in performance from Baseline at completion of training (week 16)
The Awareness of Social Inference Test (TASIT)
Time frame: Change in performance from Baseline at completion of training (week 16)
Auditory Mismatch Negativity (MMN)
Time frame: Change in performance from Baseline at completion of training (week 16)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33539561Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.
- New York State Psychiatric InstituteLink provided by the sponsor.
- Department of Psychiatry, Columbia University Medical CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Daniel Javitt, MD, PhD principal investigator
NY State Psychiatric Institute, Columbia University
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 Transcranial direct current stimulation (tDCS) and Auditory Remediation in people with Schizophrenia and Schizoaffective Disorder, run by New York State Psychiatric Institute 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 4 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 8 Jul 2021. 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 8 Jul 2021). 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?
Auditory Tone Matching Task (time frame: Change in performance from Baseline at completion of training (week 16)). 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 NCT02869334, which also lists 1 linked publication.
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 8 Jul 2021.