120 Participants NeededMy employer runs this trial

Transcranial Direct Current Stimulation for Schizophrenia

(ButtomVP Trial)

OB
Overseen ByOdeta Beggel, MA
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Nathan Kline Institute for Psychiatric Research
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether transcranial direct current stimulation (tDCS), a brain stimulation treatment, can help people with schizophrenia better recognize facial emotions. The treatment uses gentle electrical currents applied to the scalp to enhance brain function related to processing facial emotions. Individuals with schizophrenia or schizoaffective disorder who are on medication and have no history of significant head trauma or substance abuse may be suitable for this study. Participants will receive either the active tDCS treatment or a placebo to compare outcomes. As an unphased study, this trial provides a unique opportunity to contribute to groundbreaking research that could improve understanding and treatment of schizophrenia.

What prior data suggests that transcranial direct current stimulation is safe for improving face emotion recognition in schizophrenia?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe for people with schizophrenia. In various studies, patients handled the treatment well. The most common side effects were mild, such as itching or tingling at the application site. No serious problems were reported in connection with tDCS.

These consistent results across different studies indicate that tDCS is not only safe but also may help improve symptoms of schizophrenia. Prospective participants might find this information reassuring regarding the treatment's safety.12345

Why are researchers excited about this trial?

Researchers are excited about Transcranial Direct Current Stimulation (tDCS) for schizophrenia because it offers a non-invasive way to potentially improve brain function by applying a mild electrical current to specific areas of the brain. Unlike traditional antipsychotic medications, which often target dopamine and serotonin levels, tDCS focuses on modulating brain activity directly, which might reduce symptoms with fewer side effects. Additionally, the personalized, high-definition approach of tDCS allows for targeted stimulation, which could enhance its effectiveness and precision compared to broader pharmacological approaches.

What evidence suggests that transcranial direct current stimulation is effective for improving face emotion recognition in schizophrenia?

Research has shown that transcranial direct current stimulation (tDCS), a technique participants in this trial may receive, can enhance thinking skills in people with schizophrenia. Studies have found that tDCS lessens negative symptoms, such as avoiding social interactions and showing little emotion. It has also improved focus and memory. Evidence suggests that tDCS can reduce auditory hallucinations, which are common in schizophrenia. Overall, tDCS appears promising as an additional treatment to help manage schizophrenia symptoms.25678

Who Is on the Research Team?

DC

Daniel C Javitt, MD, PhD

Principal Investigator

Nathan Kline Institute

AM

Antigona Martinez, PhD

Principal Investigator

Nathan Kline Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

SCID DSM-5 diagnosis of Sz/SzAff
Competent and willing to sign informed consent
No more than moderately ill
See 5 more

Exclusion Criteria

Significant neurological illness or history of significant head trauma
Significant risk for suicide
Has a history of an illness, disease, condition injury, or disability which, in the opinion of the principal investigator, may interfere with the completion of all study requirements per protocol, impact the quality of the data, or the validity of the study results, including unstable physical illness, significant neurological illness, significant head trauma
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessment and physiological assessments

1 week
2 visits (in-person)

Treatment

Participants receive either active or sham tDCS during ERP and fMRI sessions

2 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Sham Stimulation
  • Transcranial Direct Current Stimulation

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active tDCSExperimental Treatment1 Intervention
Group II: Sham tDCSPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nathan Kline Institute for Psychiatric Research

Lead Sponsor

Trials
40
Recruited
3,300+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Columbia University

Collaborator

Trials
1,529
Recruited
2,832,000+

Research Foundation for Mental Hygiene, Inc.

Collaborator

Trials
68
Recruited
21,100+

Citations

Transcranial direct current stimulation and its effect on ... - PMC

Recent studies indicate that tDCS can significantly improve cognitive functioning in individuals with schizophrenia, with effects persisting ...

Efficacy and Safety of Transcranial Direct Current ...

Frontotemporoparietal tDCS was an effective and safe add-on treatment for patients with schizophrenia with prominent negative symptoms. Our ...

Adjunctive transcranial direct current stimulation for ...

The results showed that tDCS improved the PASAT score of schizophrenia patients, and intervention at 15 sessions or twice daily could also ...

Investigating the effects of transcranial direct current ...

This study provides preliminary evidence for an effective augmentation of cognitive training with tDCS in individuals with schizophrenia.

A meta-analysis of transcranial direct current stimulation for ...

A recent meta-analysis of 6 RCTs in schizophrenia reported a positive effect of tDCS on working memory and attention (Mervis et al., 2017). With respect to ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40228176/

Safety and Blinding of Transcranial Direct Current ...

This study confirms that tDCS is safe and well tolerated by patients with schizophrenia. The most frequent side effects are itching/tingling ...

Transcranial direct current stimulation and its effect on ...

Recent studies indicate that tDCS can significantly improve cognitive functioning in individuals with schizophrenia, with effects persisting beyond the ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31617873/

Efficacy and Safety of Transcranial Direct Current ...

Transcranial direct current stimulation was effective and safe in ameliorating negative symptoms in patients with schizophrenia.