Brain Stimulation and Therapy for Schizophrenia

(tACS/CBTpSZ Trial)

Overseen By Adriana Farcas, PhD, Clinical Neuroscientist

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Felicia Iftene

Disqualifiers: Substance abuse, Suicidal ideation, Neurological condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 19

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment that combines brain stimulation with therapy for individuals with schizophrenia. Researchers aim to determine if a gentle electric current (transcranial alternating current stimulation, or tACS) combined with therapy (cognitive behavioral therapy for psychosis, or CBTp) can improve thinking and emotional health by targeting brain activity. Participants will be divided into two groups: one will receive both the real brain stimulation and therapy, while the other will receive therapy with a placebo version of the stimulation. Individuals who have lived with schizophrenia or schizoaffective disorder for at least five years and experience ongoing symptoms may be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative treatment combinations that could enhance mental health care.

Will I have to stop taking my current medications?

The trial does not require you to stop your current medications, but you should not have any changes in your medication regimen for at least one month before starting the trial. Minor dose adjustments or changes for symptoms like sleep or anxiety are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that transcranial alternating current stimulation (tACS) holds promise for people with schizophrenia. Studies have found that tACS can reduce symptoms and improve mental health. Most patients tolerate tACS well, experiencing only mild side effects like slight tingling on the skin.

Other research indicates that tACS can be safely combined with cognitive behavioral therapy for psychosis (CBTp). When used with CBTp, tACS might further enhance thinking and mood. Although this treatment is still under study, early results suggest it is safe for most people. Prospective trial participants should discuss any concerns with the trial team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of tACS (transcranial alternating current stimulation) and CBTp (cognitive behavioral therapy for psychosis) for schizophrenia because it introduces a novel approach to treatment. Unlike standard medications like antipsychotics, which primarily target neurotransmitters, tACS involves gamma band electric stimulation to potentially enhance brain function and connectivity during therapy. This method could make CBTp more effective by synchronizing brain waves, potentially leading to quicker and more sustained improvements in symptoms. Additionally, the non-invasive nature of tACS offers a safer alternative with fewer side effects compared to traditional drug treatments.

What evidence suggests that this trial's treatments could be effective for schizophrenia?

Research has shown that combining transcranial alternating current stimulation (tACS) with cognitive behavioral therapy for psychosis (CBTp) could offer a promising new treatment for schizophrenia. In this trial, one group of participants will receive both active tACS and CBTp, which has improved thinking skills and overall mental health in previous studies. While tACS alone might not effectively address specific symptoms like hearing voices, its combination with CBTp can enhance the therapy's effectiveness. Studies suggest that this approach may help organize brain activity, often disrupted in schizophrenia. Overall, growing evidence indicates that tACS/CBTp could be a valuable addition to current treatments for schizophrenia. ^{1 3 4 6 7}

Who Is on the Research Team?

Felicia Iftene, Associate Professor, Md, PhD

Principal Investigator

Department of Psychiatry, Queen's University

Are You a Good Fit for This Trial?

This trial is for individuals with schizophrenia or at high risk for psychosis. Participants must meet DSM V criteria for schizophrenia and can be stratified by age and sex. They should not have comorbid metabolic conditions, substance use issues, abnormal lab work (like blood sugar or cholesterol levels), or a body mass index outside the set range.

Inclusion Criteria

Provision of written informed consent

My medication has been stable for at least 1 month, with only minor adjustments.

I understand and can follow the study's requirements.

Exclusion Criteria

Current illicit drug substance abuse

Current suicidal ideation

I am currently participating in a structured therapy program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive weekly tACS/CBTp or sham tACS/CBTp sessions for 16 weeks

16 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with booster sessions

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• tACS/CBTp

Trial Overview The study tests if transcranial alternating current stimulation (tACS) before cognitive behavioral therapy for psychosis (CBTp) improves treatment outcomes in schizophrenia when added to usual medication. It's a single-blind study with two groups: one receiving real tACS/CBTp and another getting sham tACS but real CBTp over 16 weeks, plus follow-ups.

How Is the Trial Designed?

Group I: tACS/CBTp, both active/ intervention Experimental Treatment 1 Intervention

n=14; participants living with schizophrenia/schizoaffective disorder, stable under their usual medication; tACS (gamma band electric stimulation) will be applied the first 20 minutes of the CBTp session (then the device remains in place, but the electric stimulation will be automatically stopped). The CBTp will continue up until a total of 50 minutes/session.

Group II: Sham tACS and CBTp (only CBTp active, intervention) Placebo Group 1 Intervention

n=14, same diagnosis population, gender and age matched; sham tACS, CBTp for 50 minutes/session.

Who Is Running the Clinical Trial?

Felicia Iftene

Lead Sponsor

Trials

1

Recruited

30+

Felicia Iftene

Lead Sponsor

Providence Care Hospital - Providence Care

Collaborator

Trials

1

Recruited

30+

Kingston Health Sciences Centre

Collaborator

Trials

312

Recruited

112,000+

Queen's University

Collaborator

Trials

382

Recruited

122,000+

Queen's University

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06889025

Therapeutic Improvement in People With Schizophrenia ... A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37897837/

Efficacy of transcranial alternating current stimulation for ... Conclusions: Overall, this systematic review suggests that tACS has promise as a novel, effective, and adjunctive treatment approach for treating schizophrenia.

3. withpower.com withpower.com/trial/phase-psychotic-disorders-2-2025-92cd0

Brain Stimulation and Therapy for Schizophrenia (tACS ... What data supports the effectiveness of the treatment tACS/CBTp for schizophrenia? Research shows that transcranial alternating current stimulation (tACS), a ...

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2023.1308437/full

Transcranial alternating current stimulation for schizophrenia tACS appeared ineffective in treating positive psychopathology, general psychopathology, and auditory hallucinations inherent to schizophrenia.

5. researchgate.net researchgate.net/publication/393780370_PROTOCOL_Electric_and_Physiological_Markers_Underlying_Mechanisms_and_Modulation_of_Cognitive_Functioning_and_Therapeutic_Improvement_in_Response_to_tACSCBTp_transcranial_alternating_current_stimulati

PROTOCOL. Electric and Physiological Markers, ... BACKGROUND The current guidelines give to the cognitive behavioral therapy for psychosis (CBTp), in association with medication, an ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10808327/

Transcranial alternating current stimulation for schizophrenia The use of adjunctive tACS shows promise as a viable approach to alleviate overall and negative psychopathology in individuals diagnosed with schizophrenia.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9720798/

Transcranial alternating current stimulation and its effects on ... TACS has shown promise in ameliorating symptoms of both schizophrenia and depression in patients. TACS also improves cognition in both patients and healthy ...