SchizophreniaNCT02620267
Target Engagement of the Early Auditory Processing Network by Transcranial Direct Current Stimulation (tDCS)
A study testing tDCS Stimulation in people with Schizophrenia, run by VA Greater Los Angeles Healthcare System.
Trial summary
Individuals with schizophrenia have difficulties in functioning in the community. No one really knows what factors determine how well patients manage in the real world. The purpose of this pilot study is to try a new approach to improving a potential determinant of good community functioning, namely how we process… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- tDCS Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2015to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-V diagnosis of Schizophrenia
- Estimated premorbid IQ > 70 (based on WRAT reading ability)
- Understand spoken English sufficiently to comprehend testing procedures
- Clinically stable: no psychiatric inpatient hospitalization in the last three months, no significant changes in their antipsychotic medications during the previous 6 weeks, and no significant changes in their living situation in the last two months based on data from the registry and self-report
- Ability to provide signed informed consent and cooperate with study procedures
Who cannot join
- No metal in the cranium, intracardiac lines, cardiac pacemaker, medication pump, or increased intracranial pressure
- No clinically significant neurological or other medical disease as determined by medical history (e.g., seizure disorder, stroke, heart disease, degenerative disease)
- No history of serious head injury (e.g., loss of consciousness more than 1 hour)
- No physical, cognitive, or language impairment of such severity as to adversely affect the validity of data
- No evidence moderate or severe drug or alcohol use disorder in the past six months, and not intoxicated at time of testing
- No pregnancy
About this study
Official title: Target Engagement of the Early Auditory Processing Network by Transcranial Direct Current Stimulation (tDCS): A Pilot Study
Individuals with schizophrenia have difficulties in functioning in the community. No one really knows what factors determine how well patients manage in the real world. The purpose of this pilot study is to try a new approach to improving a potential determinant of good community functioning, namely how we process sounds. Specifically, we propose to examine the benefit of transcranial direct current stimulation (tDCS), a new tool that is being developed as a safe and non-invasive neurostimulation method, for improving processing of sounds. Transcranial direct current stimulation involves placing a wet sponge electrode on the head and one on the arm. Electrical current from a device powered by a 9-volt battery will flow from one electrode to the other. A small portion of the current will pass through the skull and stimulate the brain. This procedure is non-invasive and painless and it results in increase or decrease of spontaneous neuronal firing in the brain. Neurons are brain cells that send electrochemical messages to each other. Its safety and beneficial effect on mental functions has been demonstrated in healthy individuals and several clinical populations.
The purpose of this study is to determine if transcranial direct current stimulation can effect how we process sounds.
Read the detailed description
Neurocognitive and social cognitive deficits are increasingly recognized as core features of schizophrenia. The severity of these deficits closely correlate to functional impairment and patient outcomes in this population. Current pharmacological treatments do not address these illness domains and psychosocial interventions that do are not consistently available. Underlying these higher level cognitive domains are basic sensory processing deficits in the auditory and visual realm that contribute to higher order dysfunction. Evidence of these sensory defects are not readily apparent on clinical exam and are best appreciated using functional imaging and electrophysiological measures. Interventions that remediate these sensory deficits may lead to functional improvement as sensory level improvements may cascade up to higher cognitive domains.
Deficits in auditory processing are evidenced using EEG based event related potentials (ERP). A robust measure of early auditory processing deficits in schizophrenia is the use of an auditory oddball paradigm to elicit Mismatch Negativity (MMN). The MMN ERP is generated when a rare deviant signal is detected in the context of a series of standards. The amplitude of the MMN in schizophrenia patients is decreased compared to healthy controls which reflects a deficit in detecting novel stimuli. This decreased auditory MMN has been shown to be closely correlated with deficits in auditory emotion recognition tasks in subjects with schizophrenia and patient functional outcomes.
This deficit in early auditory processing is thought to be secondary to regions of cortical hypoactivity. Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique that targets cortical regions with direct current and can either increase or decrease cortical excitability depending on the polarity of the tDCS electrode. The MMN network is composed of several generators that serve to process the auditory signal, establish an auditory memory trace, and signal the appearance of the deviant signal. The initial aim of this proposed study will be to determine if tDCS stimulation over the auditory cortex can modulate early auditory processing as measured by the MMN response. Our second aim will be to determine the effect of tDCS stimulation over the auditory cortex on performance measures of auditory processing as assessed by a tone matching task.
Aims and Hypotheses
Aim 1 Determine whether the early auditory processing network can be engaged and modulated by tDCS of the superior temporal lobe, where the earliest generators of the network maybe located, as assessed by changes in the auditory mismatch negativity ERP.
Hypothesis 1 Active tDCS stimulation of the superior temporal lobe will modulate the early auditory processing network resulting in an effect measurable by amplitude changes in the mismatch negativity ERP compared to control sham stimulation.
Aim 2 Determine the effect of tDCS at the temporal generators on the early auditory processing network as assessed by the tone matching task performance measure
Hypothesis 2 Active tDCS stimulation of the temporal generators will modulate the early auditory processing network resulting in a performance change on the tone-matching task compared to sham control stimulation.
Study Protocol
The study will be a within subject, cross over design counterbalanced for order of both stimulation condition and post-stimulation measurement. All patients will receive anodal, cathodal and sham stimulation targeted bilaterally to the superior temporal region (unipolarity, dual-site stimulation). We do not have a directional prediction for the active stimulations (anode and cathode) in terms of increasing or decreasing the amplitude of the MMN ERP, but we do expect active stimulation to change the MMN ERP amplitude. Patients with schizophrenia will be randomly assigned to one of six block stimulation sequences counterbalanced for order of stimulation condition. The goal will be to have complete and usable data from 12 subjects, and thus up to 30 subjects will be enrolled to account for screen failures and drop-outs. At the first visit, subjects will be screened, assessed, and consented if they meet selection criteria. They will then be randomized to one of the counterbalanced stimulation sequences and receive their first stimulation session followed by EEG assessment and tone matching task. Subjects will return in one week for visit 2 and the following week for visit 3. At visits 2 and 3, subjects will receive a tDCS session followed by EEG and tone matching task assessment. All visits will be separated by at least 1 week to washout the effect from the previous stimulation. Each patient will return for a total of 3 stimulation visits.
- Conditions
- Schizophrenia
- Being tested
- tDCS Stimulation
- Keywords
- Mismatch Negativity, Transcranial Direct Current Stimulation, MMN, tDCS
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS StimulationDevice
Subjects will receive tDCS stimulation over the auditory cortex for 20 min. For anodal stimulation the anode electrodes will be placed over the auditory cortex. For cathodal stimulation, the cathode electrodes will be placed over the auditory cortex. For sham stimulation, the anode electrodes will be placed over the auditory cortex and current turned on for 30 sec before being turned off to simulate the sensation of active stimulation.
| Study group | Role | What they receive |
|---|---|---|
| tDCS Stimulation | Experimental | Each subject will receive all three types of stimulation on separate days- anodal, cathodal, and sham stimulation Receives: Device: tDCS Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mismatch Negativity- Auditory Oddball Paradigm
Measured: 20 min after each stimulation condition
Secondary outcomes (1)
Tone Matching Task
Performance based measure of tone discrimination
Measured: 40 min after each stimulation condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study start15 Dec 2015
- Primary completion30 Dec 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Greater Los Angeles Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Walter Dunn, VA Greater Los Angeles Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620267
- Sponsor's protocol ID
- 2015-050587
- Other IDs
- 2015
- Status last verified
- May 2020
- First submitted
- 30 Nov 2015
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Engagement of the Early Auditory Processing Network by Transcranial Direct Current Stimulation (tDCS): A Pilot Study
- ClinicalTrials.gov ID
- NCT02620267
- Acronym / sponsor ID
- 2015-050587
- Conditions
- Schizophrenia
- Keywords
- Mismatch Negativity, Transcranial Direct Current Stimulation, MMN, tDCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- VA Greater Los Angeles Healthcare SystemUS federal agency
- Study start
- 15 Dec 2015 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals with schizophrenia have difficulties in functioning in the community. No one really knows what factors determine how well patients manage in the real world. The purpose of this pilot study is to try a new approach to improving a potential determinant of good community functioning, namely how we process sounds. Specifically, we propose to examine the benefit of transcranial direct current stimulation (tDCS), a new tool that is being developed as a safe and non-invasive neurostimulation method, for improving processing of sounds. Transcranial direct current stimulation involves placing a wet sponge electrode on the head and one on the arm. Electrical current from a device powered by a 9-volt battery will flow from one electrode to the other. A small portion of the current will pass through the skull and stimulate the brain. This procedure is non-invasive and painless and it results in increase or decrease of spontaneous neuronal firing in the brain. Neurons are brain cells that send electrochemical messages to each other. Its safety and beneficial effect on mental functions has been demonstrated in healthy individuals and several clinical populations.
The purpose of this study is to determine if transcranial direct current stimulation can effect how we process sounds.
Detailed description
Neurocognitive and social cognitive deficits are increasingly recognized as core features of schizophrenia. The severity of these deficits closely correlate to functional impairment and patient outcomes in this population. Current pharmacological treatments do not address these illness domains and psychosocial interventions that do are not consistently available. Underlying these higher level cognitive domains are basic sensory processing deficits in the auditory and visual realm that contribute to higher order dysfunction. Evidence of these sensory defects are not readily apparent on clinical exam and are best appreciated using functional imaging and electrophysiological measures. Interventions that remediate these sensory deficits may lead to functional improvement as sensory level improvements may cascade up to higher cognitive domains.
Deficits in auditory processing are evidenced using EEG based event related potentials (ERP). A robust measure of early auditory processing deficits in schizophrenia is the use of an auditory oddball paradigm to elicit Mismatch Negativity (MMN). The MMN ERP is generated when a rare deviant signal is detected in the context of a series of standards. The amplitude of the MMN in schizophrenia patients is decreased compared to healthy controls which reflects a deficit in detecting novel stimuli. This decreased auditory MMN has been shown to be closely correlated with deficits in auditory emotion recognition tasks in subjects with schizophrenia and patient functional outcomes.
This deficit in early auditory processing is thought to be secondary to regions of cortical hypoactivity. Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique that targets cortical regions with direct current and can either increase or decrease cortical excitability depending on the polarity of the tDCS electrode. The MMN network is composed of several generators that serve to process the auditory signal, establish an auditory memory trace, and signal the appearance of the deviant signal. The initial aim of this proposed study will be to determine if tDCS stimulation over the auditory cortex can modulate early auditory processing as measured by the MMN response. Our second aim will be to determine the effect of tDCS stimulation over the auditory cortex on performance measures of auditory processing as assessed by a tone matching task.
Aims and Hypotheses
Aim 1 Determine whether the early auditory processing network can be engaged and modulated by tDCS of the superior temporal lobe, where the earliest generators of the network maybe located, as assessed by changes in the auditory mismatch negativity ERP.
Hypothesis 1 Active tDCS stimulation of the superior temporal lobe will modulate the early auditory processing network resulting in an effect measurable by amplitude changes in the mismatch negativity ERP compared to control sham stimulation.
Aim 2 Determine the effect of tDCS at the temporal generators on the early auditory processing network as assessed by the tone matching task performance measure
Hypothesis 2 Active tDCS stimulation of the temporal generators will modulate the early auditory processing network resulting in a performance change on the tone-matching task compared to sham control stimulation.
Study Protocol
The study will be a within subject, cross over design counterbalanced for order of both stimulation condition and post-stimulation measurement. All patients will receive anodal, cathodal and sham stimulation targeted bilaterally to the superior temporal region (unipolarity, dual-site stimulation). We do not have a directional prediction for the active stimulations (anode and cathode) in terms of increasing or decreasing the amplitude of the MMN ERP, but we do expect active stimulation to change the MMN ERP amplitude. Patients with schizophrenia will be randomly assigned to one of six block stimulation sequences counterbalanced for order of stimulation condition. The goal will be to have complete and usable data from 12 subjects, and thus up to 30 subjects will be enrolled to account for screen failures and drop-outs. At the first visit, subjects will be screened, assessed, and consented if they meet selection criteria. They will then be randomized to one of the counterbalanced stimulation sequences and receive their first stimulation session followed by EEG assessment and tone matching task. Subjects will return in one week for visit 2 and the following week for visit 3. At visits 2 and 3, subjects will receive a tDCS session followed by EEG and tone matching task assessment. All visits will be separated by at least 1 week to washout the effect from the previous stimulation. Each patient will return for a total of 3 stimulation visits.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tDCS Stimulation | Experimental | Device: tDCS StimulationEach subject will receive all three types of stimulation on separate days- anodal, cathodal, and sham stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- DSM-V diagnosis of Schizophrenia
- Estimated premorbid IQ > 70 (based on WRAT reading ability)
- Understand spoken English sufficiently to comprehend testing procedures
- Clinically stable: no psychiatric inpatient hospitalization in the last three months, no significant changes in their antipsychotic medications during the previous 6 weeks, and no significant changes in their living situation in the last two months based on data from the registry and self-report
- Ability to provide signed informed consent and cooperate with study procedures
Key exclusion criteria (6 listed)
- No metal in the cranium, intracardiac lines, cardiac pacemaker, medication pump, or increased intracranial pressure
- No clinically significant neurological or other medical disease as determined by medical history (e.g., seizure disorder, stroke, heart disease, degenerative disease)
- No history of serious head injury (e.g., loss of consciousness more than 1 hour)
- No physical, cognitive, or language impairment of such severity as to adversely affect the validity of data
- No evidence moderate or severe drug or alcohol use disorder in the past six months, and not intoxicated at time of testing
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 |
|---|---|---|
| tDCS StimulationSubjects will receive tDCS stimulation over the auditory cortex for 20 min. For anodal stimulation the anode electrodes will be placed over the auditory cortex. For cathodal stimulation, the cathode electrodes will be placed over the auditory cortex. For sham stimulation, the anode electrodes will be placed over the auditory cortex and current turned on for 30 sec before being turned off to simulate the sensation of active stimulation. | Device | tDCS Stimulation |
Primary outcome
Mismatch Negativity- Auditory Oddball Paradigm
Time frame: 20 min after each stimulation condition
1 secondary outcome
Tone Matching Task
Time frame: 40 min after each stimulation condition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS Stimulation in people with Schizophrenia, run by VA Greater Los Angeles Healthcare System.
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 5 inclusion and 6 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 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mismatch Negativity- Auditory Oddball Paradigm (time frame: 20 min after each stimulation condition). 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 7 May 2020.