SchizophreniaNCT03537703
Transcranial Direct Current Stimulation and Effects on Early Auditory Processing in Schizophrenia
A study testing Active tDCS + Auditory Training in people with Schizophrenia, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
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?
- Active tDCS + Auditory Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2018to 1 May 2020
- 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
- age 18-65 yrs
- At least 3 months since any hospitalization or substantial increase in level of care for an acute exacerbation of psychotic symptoms
- At least 6 months since any behaviors suggesting any potential danger to self or others; adherence to the regular administration of an antipsychotic medication if prescribed; dose of antipsychotic medication not varying by more than 25% over the 3 months prior to study participation;
- Chronic medical conditions (e.g., hypertension, diabetes, dyslipidemia) consistently treated and stable for at least 3 months prior to study participation;
- Ability to provide signed informed consent and to cooperate with study procedures.
- Able to understand spoken English sufficiently to comprehend testing procedures
Who cannot join
- History of treatment with electroconvulsive therapy within 6 months prior to study participation;
- Documented history of persistent substance use disorder within 6 months prior to study participation
- Acute medical problems
- Metallic hardware on the scalp
- Prior diagnosis of seizure or epilepsy
- Subjects requiring proxy consent or consent from a legally authorized representative (LAR)
Trial locations and contacts
1 site in 1 country.
United States1 site
West Los Angeles VA Medical Center
Los Angeles, California, 90073
About this study
Official title: Transcranial Direct Current Stimulation and Effects on Early Auditory
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, the investigators propose to examine the benefit of combining auditory training exercises with transcranial direct current stimulation (tDCS). tDCS is a new tool that is being developed as a safe and noninvasive 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 added to auditory training exercises can improve how schizophrenia patients process sound.
Read the detailed description
Neuroplasticity is the capacity of the brain to adapt and change in response to stimuli. In schizophrenia, structural and synaptic neuroplastic impairments potentially contribute to early perceptual processing deficits that in turn contribute to downstream higher cognitive dysfunction. The N-methyl-D-aspartate receptor (NMDA-R) hypofunction hypothesis of schizophrenia potentially explains the synaptic neuroplastic impairments as the NMDA receptor is a key component of synaptic plasticity. A rational treatment strategy involves targeting the underlying synaptic neuroplastic and perceptual processing deficits. That is, modulating the capacity for synaptic plasticity and remediating the processing deficits could then cascade into improved perceptual processing and eventually lead to better cognitive functioning.
Transcranial direct current stimulation (tDCS) is a non-invasive neurostimulation technique that has been shown to modulate synaptic plasticity. tDCS is promising because the technology is low cost and the treatment is well-tolerated and has a good safety profile. Both human and animal studies have implicated an essential role of the NMDA receptor in tDCS induced neuroplastic changes. Recent animal studies demonstrated that tDCS increased levels of an NMDA-R agonist and induced neuroplastic changes.
Cognitive training has been shown to induce both synaptic and structural neuroplastic changes in control and psychiatric patient populations. This approach targets specific neural systems with directed exercises that employ a combination of repetition, reward, and motivation to induce adaptive neuroplastic changes.
While both tDCS and cognitive training can induce synaptic plasticity changes, each approach has specific strengths that could converge in a cooperative manner. tDCS modulates NMDA-R activity and creates an environment that enhances the likelihood of synaptic changes to occur. However, tDCS alone has no inherent mechanism that drives change with specificity or directionality. Cognitive training employs targeted and repeated exercises, which confers specificity and directionality to synaptic changes. However, the extent of change that occurs is limited by the impaired state of neuroplasticity in schizophrenia. Conceivably, employing cognitive training in an environment enriched for plasticity could lead to enhanced and adaptive synaptic neuroplastic change.
Subjects who have a psychiatric illness and may be cognitively impaired will be included in the study. Persons with schizophrenia commonly have cognitive impairments that affect attention, memory, and executive functioning. There is considerable evidence that these deficits are linked to impairments in social and occupational functioning that are characteristic of the disorder.
The cognitive deficits and functional impairments of the illness are the target of interest in the study and therefore this patient population will be the specific targets for subject recruitment.
Objectives and Aims
The purpose of this proposal is to determine the effect of adding adjunctive cognitive training to tDCS in improving early auditory processing in schizophrenia patients.
Specific Aims
- Determine if adding a cognitive auditory training exercise concurrently to cathodal tDCS offers an advantage to improving early auditory processing over tDCS alone in schizophrenia patients.
- Determine if adding cathodal tDCS to a cognitive auditory training exercise offers an advantage to improving early auditory processing over auditory training alone in schizophrenia patients.
Study Protocol
30 individuals with schizophrenia will be randomly divided into 3 groups.
Group 1- Cathodal tDCS + auditory training exercise
Group 2- Cathodal tDCS + control condition
Group 3- Sham tDCS + auditory training exercise
Subjects in Group 1 and 2 will receive cathodal stimulation while Group 3 will receive Sham stimulation. The training component for Groups 1 and 3 will be an active auditory training program while Group 2 will engage in a control condition. On day 1, subjects will receive a baseline Tone Matching Task (TMT) and Mismatch Negativity (MMN) assessment followed by 2 sessions of tDCS. Subjects will received tDCS + training for 20 min followed by a 20 min rest period, and then a second 20 min tDCS + training session. Subjects will return the following day (approximately 21 hrs later) where they will undergo tDCS + training, a 20 min rest, and a final tDCS + training session. The post-stimulation TMT and MMN assessment will be conducted immediately following the final tDCS + training session. Each of these sessions will take approximately 3 hrs hours to complete.
- Conditions
- Schizophrenia
- Being tested
- Active tDCS + Auditory Training, Active tDCS + Control Condition, Sham tDCS + Auditory Training
- Keywords
- Transcranial Direct Current Stimulation, tDCS, Auditory Processing, tone matching
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCS + Auditory TrainingCombination product
Active tDCS will be cathodal tDCS applied bilaterally over the auditory cortex for 20 min. The auditory training exercise will 20 min of computerized auditory training using the Sound Sweeps module of the Posit Science Brain HQ
Active tDCS + Control ConditionCombination product
Active tDCS will be cathodal tDCS applied bilaterally over the auditory cortex for 20 min. The control condition will be subjects watching a silent movie for 20 min during active tDCS stimulation.
Sham tDCS + Auditory TrainingCombination product
Sham tDCS will be cathodal tDCS applied bilaterally over the auditory cortex for 1 min with the current then slowly ramped down to 0 amps over the course of another minute. The auditory training exercise will 20 min of computerized auditory training using the Sound Sweeps module of the Posit Science Brain HQ
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS + Auditory Training | Experimental | Cathodal tDCS plus concurrent active auditory training exercise Receives: Combination Product: Active tDCS + Auditory Training |
| Active tDCS + Control Condition | Active comparator | Cathodal tDCS plus concurrent control condition Receives: Combination Product: Active tDCS + Control Condition |
| Sham tDCS + Auditory Training | Active comparator | Sham tDCS plus concurrent active auditory training exercise Receives: Combination Product: Sham tDCS + Auditory Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
tone matching
Performance based measure of tone discrimination
Measured: 40 min after last stimulation/training condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start20 May 2018
- Primary completion1 May 2020
- Study completion1 May 2020
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 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
- Investigators
- Walter Dunn, Principal investigator, VA Medical Center-West Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537703
- Sponsor's protocol ID
- PCC 2017-080780
- Status last verified
- May 2020
- First submitted
- 15 May 2018
- Last updated
- 8 May 2020
- Results posted
- No
- 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 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation and Effects on Early Auditory
- ClinicalTrials.gov ID
- NCT03537703
- Acronym / sponsor ID
- PCC 2017-080780
- Conditions
- Schizophrenia
- Keywords
- Transcranial Direct Current Stimulation, tDCS, Auditory Processing, tone matching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- VA Greater Los Angeles Healthcare SystemUS federal agency
- Study start
- 20 May 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 25 May 2018 (actual)
- 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, the investigators propose to examine the benefit of combining auditory training exercises with transcranial direct current stimulation (tDCS). tDCS is a new tool that is being developed as a safe and noninvasive 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 added to auditory training exercises can improve how schizophrenia patients process sound.
Detailed description
Neuroplasticity is the capacity of the brain to adapt and change in response to stimuli. In schizophrenia, structural and synaptic neuroplastic impairments potentially contribute to early perceptual processing deficits that in turn contribute to downstream higher cognitive dysfunction. The N-methyl-D-aspartate receptor (NMDA-R) hypofunction hypothesis of schizophrenia potentially explains the synaptic neuroplastic impairments as the NMDA receptor is a key component of synaptic plasticity. A rational treatment strategy involves targeting the underlying synaptic neuroplastic and perceptual processing deficits. That is, modulating the capacity for synaptic plasticity and remediating the processing deficits could then cascade into improved perceptual processing and eventually lead to better cognitive functioning.
Transcranial direct current stimulation (tDCS) is a non-invasive neurostimulation technique that has been shown to modulate synaptic plasticity. tDCS is promising because the technology is low cost and the treatment is well-tolerated and has a good safety profile. Both human and animal studies have implicated an essential role of the NMDA receptor in tDCS induced neuroplastic changes. Recent animal studies demonstrated that tDCS increased levels of an NMDA-R agonist and induced neuroplastic changes.
Cognitive training has been shown to induce both synaptic and structural neuroplastic changes in control and psychiatric patient populations. This approach targets specific neural systems with directed exercises that employ a combination of repetition, reward, and motivation to induce adaptive neuroplastic changes.
While both tDCS and cognitive training can induce synaptic plasticity changes, each approach has specific strengths that could converge in a cooperative manner. tDCS modulates NMDA-R activity and creates an environment that enhances the likelihood of synaptic changes to occur. However, tDCS alone has no inherent mechanism that drives change with specificity or directionality. Cognitive training employs targeted and repeated exercises, which confers specificity and directionality to synaptic changes. However, the extent of change that occurs is limited by the impaired state of neuroplasticity in schizophrenia. Conceivably, employing cognitive training in an environment enriched for plasticity could lead to enhanced and adaptive synaptic neuroplastic change.
Subjects who have a psychiatric illness and may be cognitively impaired will be included in the study. Persons with schizophrenia commonly have cognitive impairments that affect attention, memory, and executive functioning. There is considerable evidence that these deficits are linked to impairments in social and occupational functioning that are characteristic of the disorder.
The cognitive deficits and functional impairments of the illness are the target of interest in the study and therefore this patient population will be the specific targets for subject recruitment.
Objectives and Aims
The purpose of this proposal is to determine the effect of adding adjunctive cognitive training to tDCS in improving early auditory processing in schizophrenia patients.
Specific Aims
- Determine if adding a cognitive auditory training exercise concurrently to cathodal tDCS offers an advantage to improving early auditory processing over tDCS alone in schizophrenia patients.
- Determine if adding cathodal tDCS to a cognitive auditory training exercise offers an advantage to improving early auditory processing over auditory training alone in schizophrenia patients.
Study Protocol
30 individuals with schizophrenia will be randomly divided into 3 groups.
Group 1- Cathodal tDCS + auditory training exercise
Group 2- Cathodal tDCS + control condition
Group 3- Sham tDCS + auditory training exercise
Subjects in Group 1 and 2 will receive cathodal stimulation while Group 3 will receive Sham stimulation. The training component for Groups 1 and 3 will be an active auditory training program while Group 2 will engage in a control condition. On day 1, subjects will receive a baseline Tone Matching Task (TMT) and Mismatch Negativity (MMN) assessment followed by 2 sessions of tDCS. Subjects will received tDCS + training for 20 min followed by a 20 min rest period, and then a second 20 min tDCS + training session. Subjects will return the following day (approximately 21 hrs later) where they will undergo tDCS + training, a 20 min rest, and a final tDCS + training session. The post-stimulation TMT and MMN assessment will be conducted immediately following the final tDCS + training session. Each of these sessions will take approximately 3 hrs hours to complete.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Active tDCS + Auditory Training | Experimental | Combination Product: Active tDCS + Auditory TrainingCathodal tDCS plus concurrent active auditory training exercise |
| Active tDCS + Control Condition | Active comparator | Combination Product: Active tDCS + Control ConditionCathodal tDCS plus concurrent control condition |
| Sham tDCS + Auditory Training | Active comparator | Combination Product: Sham tDCS + Auditory TrainingSham tDCS plus concurrent active auditory training exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18-65 yrs
- At least 3 months since any hospitalization or substantial increase in level of care for an acute exacerbation of psychotic symptoms
- At least 6 months since any behaviors suggesting any potential danger to self or others; adherence to the regular administration of an antipsychotic medication if prescribed; dose of antipsychotic medication not varying by more than 25% over the 3 months prior to study participation;
- Chronic medical conditions (e.g., hypertension, diabetes, dyslipidemia) consistently treated and stable for at least 3 months prior to study participation;
- Ability to provide signed informed consent and to cooperate with study procedures.
Key exclusion criteria (6 listed)
- History of treatment with electroconvulsive therapy within 6 months prior to study participation;
- Documented history of persistent substance use disorder within 6 months prior to study participation
- Acute medical problems
- Metallic hardware on the scalp
- Prior diagnosis of seizure or epilepsy
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 tDCS + Auditory TrainingActive tDCS will be cathodal tDCS applied bilaterally over the auditory cortex for 20 min. The auditory training exercise will 20 min of computerized auditory training using the Sound Sweeps module of the Posit Science Brain HQ | Combination product | Active tDCS + Auditory Training |
| Active tDCS + Control ConditionActive tDCS will be cathodal tDCS applied bilaterally over the auditory cortex for 20 min. The control condition will be subjects watching a silent movie for 20 min during active tDCS stimulation. | Combination product | Active tDCS + Control Condition |
| Sham tDCS + Auditory TrainingSham tDCS will be cathodal tDCS applied bilaterally over the auditory cortex for 1 min with the current then slowly ramped down to 0 amps over the course of another minute. The auditory training exercise will 20 min of computerized auditory training using the Sound Sweeps module of the Posit Science Brain HQ | Combination product | Sham tDCS + Auditory Training |
Primary outcome
tone matching
Time frame: 40 min after last stimulation/training condition
Performance based measure of tone discrimination
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 8 May 2020.
- 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.
Walter Dunn principal investigator
VA Medical Center-West Los Angeles
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 tDCS + Auditory Training in people with Schizophrenia, run by VA Greater Los Angeles Healthcare System 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 6 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 8 May 2020. 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. 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?
tone matching (time frame: 40 min after last stimulation/training 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 8 May 2020.