160 Participants Needed

Brain Stimulation for Schizophrenia

MA
EA
MA
Overseen ByMolly A Bainbridge
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Davis
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing whether a small electrical current to the forehead can help improve thinking skills in people with schizophrenia. The study will see if doing this during tasks or at rest makes a difference, and if targeting the front or back of the head is more effective. It also looks at changes in a brain chemical important for thinking. This method has been shown to enhance cognitive performance in both healthy individuals and patients with schizophrenia.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not be taking the antipsychotic clozapine. Also, you should not have had any medication changes in the past month or expect any in the next month.

Is transcranial direct current stimulation (tDCS) safe for humans?

Research shows that transcranial direct current stimulation (tDCS) is generally safe and well-tolerated in humans, including those with schizophrenia and other conditions. Studies have not reported any serious adverse effects or irreversible injuries across thousands of sessions.12345

How does transcranial direct current stimulation (tDCS) differ from other treatments for schizophrenia?

Transcranial direct current stimulation (tDCS) is a non-invasive treatment that uses a mild electrical current to stimulate specific areas of the brain, which is different from traditional drug treatments that involve medication. It has shown promise in reducing treatment-resistant symptoms like auditory hallucinations and negative symptoms by targeting the brain's frontotemporal regions, offering a novel approach for patients who do not respond well to standard antipsychotic medications.45678

What data supports the effectiveness of the treatment Transcranial Direct Current Stimulation (tDCS) for schizophrenia?

Research shows that tDCS can help reduce symptoms in people with schizophrenia, especially those who don't respond well to medication. It has been found to decrease auditory hallucinations by about 34% and improve cognitive functions like memory and attention.56789

Are You a Good Fit for This Trial?

This trial is for adults with schizophrenia, schizophreniform or schizoaffective disorder who've had stable medication for the past month and no expected changes in the coming month. They should have a normal IQ, not be on clozapine, able to understand English well enough for cognitive tasks, and capable of informed consent.

Inclusion Criteria

Normal IQ (>70; IQ will be measured by administering the Wechsler Abbreviated Scale of Intelligence (WASI) test)
No medication changes in the prior month
I am not currently taking the antipsychotic medication clozapine.
See 5 more

Exclusion Criteria

You have a pacemaker implanted in your body.
I have a history of neurological or severe psychiatric disorders.
You have vision problems that make it difficult for you to complete cognitive tests or tasks that require distinguishing colors.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial direct current stimulation (tDCS) over the dorsolateral prefrontal cortex during cognitive tasks or rest

20 minutes per session
Multiple sessions

Assessment

Electrophysiological and behavioral assessments conducted immediately following stimulation

1.5 hours per session

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Transcranial Direct Current Stimulation
Trial Overview The study tests if transcranial direct current stimulation (tDCS), which applies a small electrical current to the forehead, can improve brain function and cognition in people with schizophrenia during different conditions like rest or task performance.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: DLPFC Stimulation + TaskExperimental Treatment1 Intervention
Intervention. 20 minutes of 2 mA direct current stimulation over the dorsolateral prefrontal cortex during cognitive task completion.
Group II: DLPFC Stimulation + RestExperimental Treatment1 Intervention
Intervention. 20 minutes of 2 mA direct current stimulation over the dorsolateral prefrontal cortex during rest.
Group III: Sham Stimulation + TaskPlacebo Group1 Intervention
Placebo Comparator. 0.5-1 minutes of 2 mA direct current stimulation over dorsolateral prefrontal cortex followed by 19-19.5 minutes of sham stimulation, during cognitive task completion.
Group IV: Sham Stimulation + RestPlacebo Group1 Intervention
Placebo Comparator. 0.5-1 minutes of 2 mA direct current stimulation over dorsolateral prefrontal cortex followed by 19-19.5 minutes of sham stimulation, during rest.

Transcranial Direct Current Stimulation is already approved in United States, European Union for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Transcranial Direct Current Stimulation for:
  • Chronic pain management
  • Depression
  • Anxiety
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Transcranial Direct Current Stimulation for:
  • Chronic pain management
  • Neurological rehabilitation

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials
958
Recruited
4,816,000+

Published Research Related to This Trial

In a study of 31 adults with schizophrenia experiencing medication-refractory auditory verbal hallucinations (AVH), transcranial direct current stimulation (tDCS) showed a moderate reduction in hallucinations, with a 25%-29% improvement by the end of the second week and an additional 10% improvement maintained over four months.
The study also noted a small but significant 11% improvement in overall symptoms as measured by the Positive and Negative Syndrome Scale (PANSS-N), indicating that tDCS may provide lasting benefits for patients with persistent AVH.
Transcranial direct current stimulation for refractory auditory hallucinations in schizophrenia: Acute and 16-week outcomes.Kumar, PNS., Krishnan, AG., Suresh, R., et al.[2022]
In a study involving nine patients with schizophrenia, the combination of transcranial direct current stimulation (tDCS) and cognitive training did not show significant improvements in psychotic symptoms as measured by the Positive and Negative Syndrome Scale (PANSS).
The lack of effectiveness suggests that this specific tDCS protocol may not enhance clinical outcomes in schizophrenia, highlighting the need for larger studies to explore the potential of electric and cognitive stimulation therapies.
Effect of transcranial direct current stimulation (tDCS) over the prefrontal cortex combined with cognitive training for treating schizophrenia: a sham-controlled randomized clinical trial.Shiozawa, P., Gomes, JS., Ducos, DV., et al.[2022]
Transcranial direct current stimulation (tDCS) has shown promise in reducing treatment-resistant symptoms of schizophrenia, particularly auditory hallucinations, with an average symptom reduction of 34%.
tDCS also positively impacts cognitive functions such as learning, working memory, and attention in patients with schizophrenia, suggesting it may enhance overall cognitive performance alongside symptom relief.
Transcranial Direct Current Stimulation for the Treatment of Refractory Symptoms of Schizophrenia. Current Evidence and Future Directions.Mondino, M., Brunelin, J., Palm, U., et al.[2022]

Citations

Transcranial direct current stimulation for refractory auditory hallucinations in schizophrenia: Acute and 16-week outcomes. [2022]
Effect of transcranial direct current stimulation (tDCS) over the prefrontal cortex combined with cognitive training for treating schizophrenia: a sham-controlled randomized clinical trial. [2022]
3.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Transcranial Direct Current Stimulation for the Treatment of Refractory Symptoms of Schizophrenia. Current Evidence and Future Directions. [2022]
tDCS for auditory verbal hallucinations in a case of schizophrenia and left frontal lesion: efield simulation and clinical results. [2021]
Understanding tDCS effects in schizophrenia: a systematic review of clinical data and an integrated computation modeling analysis. [2018]
Tolerability and Safety of 219 Transcranial Direct Current Stimulation (TDCS) 2.0 mA Sessions in Adult Patients with Schizophrenia. [2023]
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]
A Literature Mini-Review of Transcranial Direct Current Stimulation in Schizophrenia. [2022]
Noninvasive direct current stimulation for schizophrenia: a review. [2021]
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