Transcranial Direct Current Stimulation for Schizophrenia

Phase-Based Estimates
1
Effectiveness
1
Safety
Imaging Research Center, Sacramento, CA
Schizophrenia
Transcranial Direct Current Stimulation - Device
Eligibility
18 - 65
All Sexes
Eligible conditions
Schizophrenia

Study Summary

This study is evaluating whether a specific type of brain stimulation can improve cognitive control and other higher-order cognitive processes.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Transcranial Direct Current Stimulation will improve 3 primary outcomes in patients with Schizophrenia. Measurement will happen over the course of Assessment will begin immediately following stimulation and last for about 1.5 hours..

Hour 5
Behavioral Response (Cognitive Control Task)
Behavioral Response (Language Task)
EEG Correlates of Language and Cognitive Control

Trial Safety

Safety Estimate

1 of 3

Side Effects for

ACTIVE tDCS - Pelvic Pain Patients
Tingling
100%
Skin redness
80%
Sleepiness
60%
Headache
20%
Trouble concentrating
20%
Acute mood change
20%
Itching
20%
Neck pain
20%
Scalp burning sensation
20%
Nausea
20%
Diziness
0%
This histogram enumerates side effects from a completed 2013 Phase 2 trial (NCT01143636) in the ACTIVE tDCS - Pelvic Pain Patients ARM group. Side effects include: Tingling with 100%, Skin redness with 80%, Sleepiness with 60%, Headache with 20%, Trouble concentrating with 20%.

Trial Design

3 Treatment Groups

Occipital Stimulation
DLPFC Stimulation
Placebo group

This trial requires 120 total participants across 3 different treatment groups

This trial involves 3 different treatments. Transcranial Direct Current Stimulation is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

DLPFC Stimulation
Device
Intervention. 20 minutes of 2 mA direct current stimulation over the dorsolateral prefrontal cortex.
Occipital Stimulation
Device
Intervention. 20 minutes of 2 mA direct current stimulation over the occipital cortex.
Sham Stimulation
Device
Placebo Comparator. 0.5-1 minutes of 2 mA direct current stimulation over the dorsolateral prefrontal cortex followed by 19-19.5 minutes of sham stimulation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Direct Current Stimulation
2014
Completed Phase 3
~1220

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessment will begin immediately following stimulation and last for about 1.5 hours.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly assessment will begin immediately following stimulation and last for about 1.5 hours. for reporting.

Closest Location

Imaging Research Center - Sacramento, CA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
No medication changes in the prior month
Stable outpatient or partial hospital status
No medication changes anticipated in the upcoming month
Normal IQ (>70; IQ will be measured by administering the Wechsler Abbreviated Scale of Intelligence (WASI) test)
Must not be currently taking the antipsychotic clozapine
Participants must be able to sufficiently speak and understand English so as to be able to understand and complete cognitive tasks.
All subjects must have the ability to give valid informed consent.
Diagnosis of schizophrenia, schizophreniform or schizoaffective disorder

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes schizophrenia?

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Schizophrenia is the most complex psychiatric disorder, characterized by a wide range of symptomology. Genetic and environmental factors can play a role, though they account for a minority of cases. Given the complexity of a disorder with such a large phenotypic variability and no clear biological abnormality, further research into its underlying causes will be of little help. Nevertheless, it is important for clinicians to be fully aware of the possible causes of schizophrenia. Some causes are more common in certain populations and are likely to become more readily apparent given recent epidemiological studies. To further our understanding and treatment, these should be reported in the medical literature as well as thoroughly discussed among specialists.

Unverified Answer

What are common treatments for schizophrenia?

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The common treatments for schizophrenia and their possible side effects and harms are illustrated. Inadequate use of these treatments may contribute to poor long-term outcomes.

Unverified Answer

What is schizophrenia?

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Schizophrenia is a mental illness characterized by a persistent and recurrent pattern of hallucinations, delusions, socially disordered behavior, and negative symptoms. It tends to run in families. Schizophrenia occurs mostly in late adolescence and young adulthood.\n

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Can schizophrenia be cured?

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Although there are many factors that determine outcome in schizophrenia treatment, there is the possibility that schizophrenia can be cured if it is treated early, carefully and aggressively. Although there are many patients that can be cured, the majority of those that can be cured will have a number of relapses. These patients would be unlikely to survive a number of relapses if they were not treated and their disease not adequately controlled. In spite of this inconsistency, a cure for schizophrenia cannot be achieved and such thinking is not conducive to understanding this significant illness.

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What are the signs of schizophrenia?

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Patients with schizophrenia display many of the same signs as those with other major psychiatric disorders; for example, a history of suicidal ideations, a family history of mental illness, or psychiatric in-patient status. Further investigation is needed to determine the extent to which these signs help in differentiating schizophrenia from other psychiatric conditions.

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How many people get schizophrenia a year in the United States?

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The best estimate is approximately 400,000 persons per year with an earlier peak in ages 25-44 years. Approximately 1,600 persons per year die from the disorder.

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What is the latest research for schizophrenia?

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This review provides an update on recent research into the schizophrenia, and in particular into a range of aspects of the disorder, such as cognition, genetics, epidemiology, treatment, and ways of finding more effective therapies.

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What is transcranial direct current stimulation?

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The authors concluded that tDCS appears to change subjective and objective measures of cognition in patients with schizophrenia. These changes were reversible, indicating that tDCS can be used as an adjunct to other treatment modalities, particularly for patients whose cognitive deficits present a significant clinical problem or who are refractory to standard medication. They also indicated the potential for combining tDCS with other protocols, such as pharmacological DBS, to produce even more gains.

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Does schizophrenia run in families?

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The studies were of varying levels of power and quality, but the results suggest a modest but significant positive correlation between the genetic risk for schizophrenia and first-degree relatives with the syndrome. The odds of a positive association increased as the degree of relatedness from the first degree relative increased. The findings of this study are consistent with earlier anecdotal evidence, especially in the case of a strong, familial contribution to the development of schizophrenia. A plausible genetic mechanism for increased risk for this disorder is reduced expression of the cAMP-response element binding protein-beta messenger RNA in the brain. The fact that reduced expression may also be involved in bipolar disorder further raises the possibility that there may be some genetic relationship between these disorders.

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What are the common side effects of transcranial direct current stimulation?

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These outcomes show that tDCS does not produce immediate and substantial side effects, in contrast to the expectation of users! As such, a further review of current beliefs for the treatment of schizophrenia, and in particular the potential benefit of tDCS, might be warranted.

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Have there been any new discoveries for treating schizophrenia?

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There have been many advances and many medications have been tested to stop hallucinations and delusions. None of them have been successful in doing so. It seems to be a mystery. The only thing that has been approved in America to treat a delusion is antipsychotic drugs. This will stop hallucinations and make the sufferer feel better. There is no cure for schizophrenia; and we must accept that there will never be one.\n

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How does transcranial direct current stimulation work?

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The present study provides novel data supporting the efficacy of tDCS. Furthermore, the results support that the antidepressant-like actions of tDCS may be mediated via NREM sleep disturbances. This suggests that neurocognitive treatment (including tDCS) may promote antidepressant effects in psychotic depressive patients.

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